Group-Based Cardiac Rehabilitation Interventions. A Challenge For Physical and Rehabilitation Medicine Physicians: A Randomized Controlled Trial

European Journal of Physical and Rehabilitation Medicine
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Group-based cardiac rehabilitation interventions. A

challenge for physical and rehabilitation medicine
physicians: a randomized controlled trial
Jannis Vasileios PAPATHANASIOU, Ivo PETROV, Maria TOKMAKOVA, Donka
DIMITROVA, Liubomir SPASOV, Nigyar DZHAFER, Dortothea TSEKOURA, Yannis
DIONYSSIOTIS, Agnaldo José LOPES, Arthur Sá FERREIRA, Eugenia
ROSULESCU, Calogero FOTI
European Journal of Physical and Rehabilitation Medicine 2020 Jan 23

DOI: 10.23736/S1973-9087.20.06013-X
Article type: Original Article
© 2020 EDIZIONI MINERVA MEDICA
Article first published online: January 23, 2020

Manuscript accepted: January 20, 2020
Manuscript revised: January 14, 2020
Manuscript received: September 24, 2019
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Group-Based Cardiac Rehabilitation Interventions. A Challenge for Physical and
Rehabilitation Medicine Physicians: a randomized controlled trial
Running Title: Group-based cardiac rehabilitation a challenge
Jannis V.PAPATHANASIOU1, Ivo PETROV2, Maria P. TOKMAKOVA3, Donka
D.DIMITROVA4, Liubomir SPASOV 5, Nigyar S. DZHAFER 6, Dorothea
TSEKOURA7, Yannis DIONYSSIOTIS 8, Arthur S. FERREIRA9, Agnaldo J.LOPES 9,
Eugenia ROSULESCU 10, Calogero FOTI 11
Institutional affiliations and locations:

1
Department of Medical Imaging, Allergology & Physiotherapy, Faculty of Dental
Medicine, Medical University of Plovdiv, Bulgaria, Department of Kinesitherapy, Medical

2
University of Sofia, Bulgaria; Clinic of Cardiology and Angiology, Acibadem City Clinic
3
Cardiovascular Center University Hospital, Sofia, Bulgaria; Department of Cardiology at
Medical University of Plovdiv, Bulgaria; 4Department of Health Management and Health

5
Economics, Faculty of Public Health, Medical University of Plovdiv, Bulgaria; Cardiac
Surgery Clinic Lozenets, University Hospital, Faculty of Medicine, Sofia University "St.
6
Kliment Ohridski" Bulgaria; Department of Health Policy and Management Faculty of
Public Health, Medical University of Sofia, Bulgaria; 7Aretaieio Hospital, Athens Medical
8
School, Athens, Greece; 1st Physical Medicine & Rehabilitation Department, National
Rehabilitation Center, Athens, Greece; 9Rehabilitation Sciences Post-graduate Program,

10
Augusto Motta University Centre, Rio de Janeiro, Brazil; Department of Physical Therapy
and Sports Medicine, Faculty of Physical Education and Sport, University of Craiova,
11
Romania; Department of Physical Medicine and Rehabilitation, Clinical Sciences and
Translational Medicine, Tor Vergata University, Rome, Italy.
Corresponding author: Jannis Papathanassiou, MD, PhD, Department of Medical Imaging,
Allergology & Physiotherapy, Faculty of Dental Medicine, Medical University of Plovdiv, Bulgaria
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Department of Kinesitherapy, Faculty of Public Health, Medical University of Sofia, 8 Bialo More str.,
Sofia, Bulgaria, E-mail: giannipap@yahoo.co.uk
ABSTRACT
BACKGROUND: In recent decades, many studies are focused on different training
modalities comparison in patients with cardiac diseases. High intensity aerobic interval
training (HIAIT) has been considered as an alternative approach to moderate-intensity
continuous training (MICT) in rehabilitation of patients with chronic heart failure (CHF).
AIM: To highlight the superiority of the modified group-based HIAIT intervention (m-
Ullevaal) compared to the moderate-intensity continuous training (MICT), also to encourage
physical and rehabilitation medicine (PRM) physicians to apply the m-Ullevaal intervention
in routine cardiac rehabilitation (CR) practice.
DESIGN: А single-blind, prospective randomized controlled trial.
SETTING: Medical Center of Rehabilitation and Sports Medicine, Plovdiv, Bulgaria
outpatients were enrolled.
POPULATION: One hundred and twenty subjects of both genders, mean age of 63.73 ± 6.68
years, with stable CHF, NYHA classes II to IIIB, were randomly assigned to m-Ullevaal
group (N=60) or to MICT (N. =60) group. Both CR protocols were conducted throughout a
12 week period.
METHODS: Functional exercise capacity (FEC), assessed with six-minute walk test
(6MWT), and peak oxygen uptake (VO2 peak), left ventricular ejection fraction (LVEF), m-
Borg’s perceived exertion scale (mBPES), and quality of life (QoL) were outcome measures
evaluated.
RESULTS: Significant improvement in FEC (P<0.001), LVEF (P<0.001), mBPES and QoL
(P<0.001), was observed 12 weeks after both CR interventions (T2). However, the
participants performed m-Ullevaal protocol achieved a greater improvement compared to
those performed MICT (P<0.001).
CONCLUSIONS: The m-Ullevaal protocol seems to be more beneficial and more effective
compared to MICT. PRM physicians can efficiently apply the m-Ullevaal protocol in CHF
patients rehabilitation.
CLINICAL REHABILITATION IMPACT: Group-based HIAIT interventions can be

widely applied by PRM physicians in CHF patients rehabilitation.Кеy words: M-Ullevaal-
Moderate continuous training- Six-minute walk test- Intervention
Introduction
Exercise training (ET) is the mainstay and the most studied component of cardiac
rehabilitation (CR) programs with varying recommendations in specific guidelines across
countries. 1 The clinical benefits of ET in patients with chronic heart failure (CHF) are well
documented and include improvements in cardiovascular, lung and skeletal muscle functions,
endurance, quality of life (QoL), inflammation, depressive symptoms, stress and cognitive
functions.2 Before prescribing an appropriate CR program, assessment focused on functioning
is the major step which can be done using the brief International Classification of
Functioning, Disability and Health (ICF) Core Sets for cardiopulmonary conditions for acute
and post-acute care as well as ICF Core Sets for chronic ischemic heart disease.3 In recent
decades, many studies are focused on comparison of different training modalities in patients
with cardiac diseases.4,5 High-intensity aerobic interval training (HIAIT), defined as repeated
short bouts of exercise exceeding 90% of VO2 peak interspersed by recovery periods of no or
very low intensity activity (< 40% of VO2 peak). 6, 7 The influence of HIAIT is beneficial on the
diastolic function of the left ventricle, on elastic properties of the aorta, and on the QoL of
patients with CHF, even among individuals having an implantable cardioverter-defibrillator or
being in higher NYHA class. HIAIT has been considered as an alternative approach to
moderate-intensity continuous training (MICT). Various HIAIT protocols with different stage
durations, intensities, and nature of recovery are applied in rehabilitation of patients with
8
chronic heart failure (CHF). Group-based Ullevaal protocol is a widely used HIAIT
intervention applied in Scandinavian countries, among patients with CHF. The above
mentioned protocol is consisted of 3 high intensity intervals and 2 moderate intensity
intervals. 9 During 3 high intensity intervals, subjects are encouraged to achieve 15 to 18 on
the Borg scale as well as 11 to 13 points during the two moderate intervals in the same scale.
Group-based Ullevaal protocol improves the functional exercise capacity (FEC) of CHF
patients, as well as the symptoms of anxiety and depression as the limited activities of daily
living (ADL) resulting in poor QoL.11 10

It has been shown that the depression in patients with
CHF is associated with mortality, worse health related QoL(HRQoL), and the frequent use of
health services and costs/economic burden.12 Patients with CHF have markedly impaired
HRQoL, compared to with other chronic diseases as well as healthy population.13
The aim of the present study was to highlight the superiority of the m-Ullevaal intervention
compared to the MICT, and to encourage PRM physicians to apply this protocol intervention
in rehabilitation of patients with CHF. In order to compare and quantify the effect of both CR
interventions applied in the present study, we used outcome measures for FEC, BPES, LVEF
and QoL.14, 15
Materials and methods
Data collection
This prospective randomized controlled trial with a single-blinded (assessor-blinded), design
was conducted in Medical Center of Rehabilitation and Sports Medicine, Plovdiv, between
January 2012 and June 2015. The study was approved by the Ethics Committee of the
Medical University of Plovdiv under number (approval # R 3/, date 05/07/2015) and was in
accordance with the World Medical Association’s code of Ethics (Declaration of Helsinki,
1967). All participants agreed to participate were informed about the aims, procedures,
benefits and potential risks of the trial, and signed the consent form.
Participants
One-hundred and twenty patients with stable CHF, New York Heart Association (NYHA)
classes II to IIIB; left ventricular ejection fraction ≤40; clinically and pharmacologically
stable (>3 months) prior to participation, who were diagnosed by experienced cardiologists
(I.P, M.T) from the Department of Cardiology at Medical University of Plovdiv were
included in the study. The study participants were recruited by cardiologists from the
Department of Cardiology at Medical University of Plovdiv and were from the Plovdiv
Region. There were no eligibility criteria of age and gender. Inclusion criteria were: adult
patients of both genders with stable CHF, New York Heart Association (NYHA) classes II to
IIIB; left ventricular ejection fraction ≤40; clinically and pharmacologically stable (>3
months) prior to participation.
Exclusion criteria applied were the diagnosis of diabetes, major surgery or recent myocardial
infarction within <4 weeks, unstable angina, uncontrolled ventricular and supraventricular
arrhythmias, average grade or high-grade aortic stenosis, ΝΥΗΑ ΙV class, blood pressure ≥
200/110 mmHg, six-minute walking distance (6MWD) >550 m; hypertrophic obstructive
cardiomyopathy, recent pulmonary embolism, deep vein thrombosis, fever, recent stroke,
physical disability that precluded safe and adequate testing, and mental impairment with
limited ability to cooperate.
The included subjects (N. =120) were randomly allocated to m-Ullevaal group or to MICT
group, using a stratified block randomization (www.randomization.com) by age, gender,
NYHA class, and cause of CHF. The investigator (I.P) determined if a subject was eligible for
inclusion in the trial was unaware, when this decision was made, of which group the subject
would be allocated. Another investigator (D.T) checked correct patient allocation according to
the block randomization. When the size of blocks (number of patients) was even numbers
allowing for subjects to be randomly assigned to the two CR groups. After unmasking at the
end of the study, we checked that no errors had been made in allocation.
Our study was performed by a multiprofessional CR team, composed of PRM physicians,
cardiologist, physiotherapists, exercise physiologist, rehabilitation nurse, occupational
therapist, clinical psychologist, social worker and dietician, all with expertise in CR.
This study conforms to all TIDieR and CONSORT checklists and reports the required
information accordingly (see Supplementary Checklist).16,17 All outcome measures before and
after both CR interventions were performed by a research assistant who was blinded to the
allotment.
Interventions
All participants received baseline evaluations before both CR interventions and then 12 weeks
post-intervention (T2). Outcome measures included FEC (6MWT, VO2peak), (LVEF), mBPES
and QoL. Demographic data were collected.
Six-minute walk test - (6MWT)
Functional exercise capacity (FEC) was estimated using the 6MWT, which has been used
extensively in clinical trials to estimate aerobic capacity in patients with chronic heart and
lung diseases, as well as in the assessment of various rehabilitative interventions. 18 It’s proven
that 6ΜWT is more representative of ADLs when compared with other field tests, and is a
predictor of morbidity and mortality in many clinical conditions. 19

The 6ΜWT was
20
performed following the most current American Thoracic Society (ATS) guidelines.
Participants were asked to walk the greatest possible distance in six minutes, going back and
forth between the cones, without running in a marked corridor (30 meters). The subjects were
familiar with the 6ΜWT and standardized encouragement phrases were used every minute
throughout the test. The participants were instructed to discontinue the 6ΜWT if they felt
dizzy or experienced leg cramps, chest pain, intolerable dyspnea, angina, etc. Two tests with
30-m rest times were performed on the same day. The 6ΜWT with the longest distance
covered was selected for analysis, and the distance covered was expressed in meters. The
subjects performed the 6ΜWT at baseline (T1) and after 24 training sessions (T2).
Cardiopulmonary exercise testing-(CET)
The eligible subjects performed a standard ramp protocol on electronically braked cycle
ergometer (Pure Bike 4.1, Tunturi, Almere, Finland). After 10 minutes of cycling at 5W, the
load was increased by 25 W every 10 seconds until exhaustion. Participants were encouraged
to cycle at a pedal frequency between 65 and 80 revolutions per minute (rpm). The test was
ended when the pedal frequency fell below 40 rpm and the subjects were exhausted.
-Gas exchanges were collected and analyzed during the exercise stress test by a metabolic
monitor VO2000 (Med Graphis, St Paul, Minnesota, USA) using the breath-by-breath
technique. Maximal aerobic power (VO2 peak) was determined as the VO2 achieved at the
patient’s peak workload, an average over the last 15 s. VO2 peak is an independent predictor of
mortality and morbidity in CHF patients.6 The portable gas analyzer VO2000 (Med Graphis,
St Paul, Minnesota, USA) and the HR monitor (Onyx, Nonin, Plymouth, Minnesota, US)
were calibrated before each test according to manufacturer instructions. The VO2 peak was
measured at the baseline (T1), and after 24 training sessions (T2). The CET was supervised by
PRM physician and exercise physiologist of multiprofessional CR team.
Left ventricular ejection fraction - (LVEF)
The left ventricular ejection fraction - (LVEF) was evaluated by a cardiologist (M.T) member
of CR team, using dedicated echocardiographic equipment (Vivid 7, General Electric, Boston,
MA, USA), according to the recommendations of the American Society of Echocardiography.
LVEF was calculated using Simpson’s method at the baseline (T1), and after 24 training
sessions (T2).
Quality of Life - (QoL)
QoL was evaluated using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Participants completed the validated in Bulgaria version of MLHFQ at baseline (T1) and after
24 training sessions. The MLHFQ is a 21-item questionnaire that includes 8 items on physical
aspects, 6 on emotional aspects, and 7 other items that cover social, work, and sexual topics.
15
It measures the patient’s perception of how CHF symptoms have affected their life during
the preceding month. The MLHFQ score can range from 0–105 with higher scores indicating
greater perception of severity and intrusiveness of heart failure related symptoms.
The MLHFQ was administered by investigators (D.D and N.D) and social worker blinded to
group assignment at baseline (T1) and after 24 training sessions (T2).
M-Ullevaal protocol
The m-Ullevaal protocol is a modified group-based HIAIT intervention consisting of three
high-intensity intervals (HR max: 90%) and two intervals of moderate intensity (HR max:
70%) over a 12-week period, for a total of 24 training sessions. 21 The training in cases of
missed training sessions because of illness or public holidays, the training period was
extended up to 18 weeks. The benefits of group-based CR interventions in improvement of
functional capacity, body awareness and QoL of patients with heart diseases are well-
9
documented. They are widely used interventions in Scandinavian hospitals due to cost
effectiveness, close supervision and peer encouragement from the PRM physician. Warm-up
and cool-down periods were included in accordance with American College of Sports
Medicine guidelines.22 Figure 2 Panel A, presents the exercise intensity curve of the m-
Ullevaal protocol which was adjusted based on the individual pre-programmed target heart
rate (HR)23, and was gradually increased in order to prevent participants from myocardial
24
ischemia, injuries and falls. During high intensity intervals participants performed various
exercises for upper and lower limbs (i.e. flexion, extension, abduction, adduction and
rotations) (Figure 2 Panel B).25 The main goal of the high-intensity intervals was to improve
the oxygen uptake of the subjects. During high-intensity intervals subjects achieved 90% of
the HR max as well as 70% of the HR max during the moderate intensity intervals.
Furthermore, specially selected music pieces were applied to adjust the intensity of each
training interval. 26
Flexibility and strength exercises were core components of the two moderate intensity
intervals (Figure 2 Panel C). The main goal of these intervals was to increase the range of
motion of large joints. 27, 28 The perceived exertion during the various training intervals of m-
Ullevaal protocol was evaluated using the m-Borg’s perceived exertion scale (mBPES) which
14
ranges from 0 (nothing at all) to 10 (extremely severe). Prior the application of the mBPES
a physiotherapist explained what the points meant. Participants were encouraged to achieve 5
to 7 on mBPES (i.e. 90% of the maximum (HRmax) during high-intensity intervals, and 2 to
4 on mBPES (i.e. 70% of the HRmax) during the moderate intensity intervals.
Each training session of the m-Ullevaal protocol lasted 40 minutes, which is 10 min shorter
than the original protocol. 9 By shortening the duration of the m-Ullevaal intervention, the risk
of early exhaustion and boredom among the participants were avoided.29 Current national and
international guidelines state that exercise and education should be included in CR programs.
It’s proven that integrated patient’s education may reduce fatal and/or non-fatal
30
cardiovascular events and improve health related quality of life (HRQoL). In order to
reduce the overall cost of the m-Ullevaal intervention a total of twelve (N. =12) group
counseling sessions were offered to the participants (Table II). The counseling sessions were
provided by health professionals (i.e. occupational therapist, clinical psychologist, social
worker, rehabilitation nurse, and dietician) of the multiprofessional CR team.
Various educational topics, focused on deficits in patients' knowledge on CHF, dietary,
psychological and welfare benefits system were discussed. One of the most important tasks of
the counseling sessions was to motivate participants for maintaining, and adhering to lifelong
31
exercise at different settings. Each counseling session lasted 40 minutes. Individual
counseling sessions were offered to participants, who expressed further interest. 32
Both CR protocols were conducted throughout a period containing on average 24 free of
charge training sessions and followed the principles of the Helsinki Declaration. During the
intervention period, medical treatment did not change, except for alterations in diuretic
dosages as is normal in clinical practice.
All training sessions were supervised by PRM physician, cardiologist and physiotherapist
with more than 10 years’ experience in CR. 33MICT protocol
The MICT intervention was performed on electromagnetically braked cycle ergometers (Pure
Bike 4.1, Tunturi, Almere, Finland). Participants trained in groups consisted of 5-8
individuals throughout a period containing on average 24 training sessions for twelve
consecutive weeks. The participants were encouraged to achieve 2 to 4 on mBPES (i.e. 70%
of the HRmax). Each MICT session lasted 40 minutes, and was supervised by PRM physician
and exercise physiologist of CR team.
Statistical Analysis
The Shapiro–Wilk statistic was used to test the normality of the distribution of all variables.
The sample size was calculated based on pilot study with 75 patients. A mixed-model
ANOVA analysis was performed on outcome measures (6MWT, VO2peak, LVEF, mBPES and
MLHFQ score). Mixed ANOVA has only one "within-subjects" factor and the other factor is
a "between-subjects" factor. In our study time (levels: T1 and T2) was the within-subjects
factor. Subjects had been separated in two groups by the type of applied intervention - m-
Ullevaal and MICT respectively i.e. the between-subjects factor was the type of the applied
intervention. We also controlled for health characteristics and behavior (NYHA class, causes
of CHF, smoking, compliance). Statistical significance level was set at p<0.05 for both main
and interaction effects. Data are expressed as mean ± standard deviation (SD). In all statistical
analyses the SPSS 18.0 statistical software package for Windows (SPSS Inc. 2010, Chicago,
IL, USA) was utilized.
Results
A flow chart summarizing the distribution of the participants during each stage of the study is
presented in Figure 1. One hundred and forty six subjects (N. =146) were initially recruited to
Medical Center of Rehabilitation and Sports Medicine, Plovdiv, between January 2012 and
June 2015. Fourteen subjects (N. =14) were excluded, as well 12 were lost to follow up. Thus,
the sample included one hundred and twenty (N. =120) subjects (70 males and 50 women),
with stable CHF, NYHA classes II to IIIB, with mean age of 63.73 ± 6.68 years, randomly
assigned to m-Ullevaal (N. =60) or MICT group (N. =60) for 12-week intervention. All 120
patients included in the study (male-to-female ratio: 70/50, age 63.73 ± 6.68 years) completed
both CR interventions. No adverse events were observed during the study period in either CR
group. Demographic and clinical characteristics of the two CR groups, as well as subject’s
baseline performances according to different tests are reported in Table I. There were no
missing values.
No significant between-group differences were observed at baseline concerning age, gender,
FEC (6MWT, VO2 peak), (LVEF), mBPES, and QoL (Table I). After 24 training sessions
significant improvement was observed in FEC, measured by 6MWT in both CR groups.
The improvement observed in the six-minute walking distance (6MWD) was significantly
greater in the m-Ullevaal group (73 m) compared to the MICT group (46 m). Participants
from m-Ullevaal group achieved 16.86% average improvement of baseline 6MWD vs 10.58%
improvement achieved by the MICT group respectively, p<0.001] (Table II). VO2 peak
increased by 29.16% in the m-Ullevaal group (13.49±3.78 to 16.97±3.65 ml·kg-1·min-1,
p<0.001), and by 19.68% in the MICT group (12.51±3.56 to 14.53±3.09 ml·kg-1·min-1,
p<0.001) (Table II). LVEF improved significantly among both CR groups after 24 training
sessions. The LVEF improvement achieved in the m-Ullevaal group was significantly higher
compared to the MICT group (respectively, 13.44±2.08 vs. 10.48±1.50, p<0.001). A high,
statistically significant decrease was observed in mBPES from baseline to T2 in both CR
groups. However the decrease observed in m-Ullevaal group was significantly greater than the
MICT group (respectively, -29.79±8.88 % vs.-25.71±11.29%, p<0.001), (Table II).
A significant improvement in MLHFQ scores was also found from baseline to T2 in both CR
groups. The mean MLHFQ scores was significantly higher in the m-Ullevaal group than in
MICT group (average pre-post difference of 20% vs. 6%, p<0.001) (Table II). Compliance of
the m-Ullevaal group was higher compared to MICT group, respectively 88.61%
(21.27±1.58) vs. 87.22 % (20.83±1.76) (Table II).
The mixedANOVA analysis indicated that the group-time interaction had significant effects
after controlling for age, gender, health status on the MLHFQ score [F(1,113)=77.66;
p=0.026, 2=0.41] (Figure 3).
The multivariate test of pre-post changes in outcome measures (6MWT, VO2 peak, LVEF, m-
BPES and MLHFQ) found that the effect of rehabilitation intervention was significant [F
(5.114) = 59.646; p<0.001] and accounted for 72.3% of variance. Preliminary results of the
present study were published elsewhere. 21
Discussion
The main aim of this study was to highlight the superiority of the m-Ullevaal intervention
compared to the MICT, as well as to encourage the PRM physicians to apply the m-Ullevaal
protocol in CHF patients rehabilitation.
Not surprisingly, differences in FEC measured by 6MWT and VO2 peak have been observed
among both CR interventions. An important aspect of the 6MWT is its ability to predict a
patient’s prognosis and evaluate the changes in a patient’s FEC. Subjects of both CR groups
of our study showed better performances at six-minute walking distance (6MWD). However,
the improvement was superior in m-Ullevaal intervention (p=0.0026). The intragroup increase
observed in the 6MWD was respectively 17% and 11% for m-Ullevaal and MICT
interventions. Freyssin et al. conducted a study with methodology similar to the present study,
34
using the 6MWT to assess functional capacity of patients with CHF. These authors found
that patients performed high intensity interval training (HIIT) protocol achieved average
increase by 12% in the 6MWD. In our study, participants performed m-Ullevaal intervention
reported greater improvement in the 6MWD respectively 17 % compared to the increase
referred in the above mentioned study.
Since CR groups of our study can be comparable with training groups from other studies with
similar methodology, it is evident that m-Ullevaal showed the similar statistical improvement
regarding the 6MWT. 9 Subjects performed the m-Ullevaal protocol achieved greater average
improvement in 6MWD (73 m), than the improvement achieved by MICT group (46 m).
Shoemaker et al. reported good alignment of the minimum detectable difference (MDD95%)
and minimal clinical important difference (MCID) for the 6MWT, suggesting that a change of
approximately 30 meters to 32 meters can be considered to be clinically meaningful.35
Therefore, clinically meaningful changes regarding 6MWD were observed in both CR groups.
However, the clinically meaningful change was superior in m-Ullevaal intervention compared
to MICT group.
In many studies have been shown that HIAIT interventions improves VO2peak values in CHF
patients to a greater extent with respect to MICT.6-8 Most recently, Elliott et al. referred the
36
superiority of HIAIT comparable to MICT in improving the VO2peak. In our study VO2 peak
increased in both CR groups after 12 weeks of rehabilitation, however the improvement was
greater in the m-Ullevaal group. Moreover the 29% increase in VO2 peak observed in m-
Ullevaal group was greater compared to the increase published from other investigators in
other studies. 37 The significant improvement in VO2 peak could possibly be explained with the
poor baseline FEC (VO2peak= 13 mL/kg/min) of the included subjects, as well as with the
influence of the m-Ullevaal protocol.
Swank et al. concluded that every 6% increase in VO2peak (adjusted for other significant
predictors) is associated with a 5% lower risk of the primary endpoint (hazard ratio [HR] =
0.95; CI = 0.93–0.98; p < 0.001) and a 7% lower all-cause mortality (HR = 0.93; CI 0.90–
0.97; p < 0.001).38
The improvement on LVEF achieved among subjects performed m-Ullevaal protocol suggests
that model was highly effective in improving SF. LVEF increased by 5 percentage points,
which corresponds to 13.4% in relative terms (P<0.001) (Table II).
In fact, the above mentioned improvement in LVEF was achieved after 24 training sessions of
HIAIT and was higher compared to the improvement referred in the study of Angadi et al. 39
The mBPES applied in our study is considered as a simple and cheap method of self-
monitoring that correlates with submaximal effort. The positive correlation of mBPES with
HR among patients with CHF even those on beta blocker medication also can be quite useful
40
in prescribing exercise training intensity. Participants did not have any difficulties
understanding the various training intervals in m-Ullevaal as guided by the mBPES.
The greater decrease in m-Borg scale achieved in m-Ullevaal (-29.79±8.88 %) demonstrating
its better acceptance from the participants with CHF compared to MICT (-25.71±11.29%).
The MLHFQ is a tool specifically designed to measure QoL of patients with CHF. The
improvement in MLHFQ scores achieved in both CR groups at 12 weeks post intervention
may be associated to the ‘poor’ MLHFQ scores at baseline, which were lower, compared to
the MLHFQ scores from other studies with similar design and consequently, provide big
space for further improvement. 41 However the improvement in MLHFQ score observed in the
m-Ullevaal group, with a mean difference of 7.08 points was significantly greater than the
MLHFQ score achieved in the MICT group resp. 2.32 points, which was a clinical meaningful
difference (CMD) for the m-Ullevaal group (Table II). Rector et al. argued that a 5-point
change in the total MLHFQ score can be considered clinically significant, allowing
conclusions to be drawn about the clinical effectiveness of an intervention.15 The related
changes in MLHFQ score and changes in 6MWD in our study indicated that changes in QoL
were associated to the improved FEC.
The reduced number of participants (N. =8) included in each subgroup for both CR
interventions of our study was suggested on one hand to facilitate the work of the CR team,
and on another to reduce the overall cost of the rehabilitation intervention. 29 It is also evident
that any cost reduction is well accepted in the times of deepening economic crisis and the
prolonged reforms of the Bulgarian health-care system, especially taking into consideration
the progressive increase in cardiac diseases. As in the original Ullevaal protocol high
compliance was observed also in our study among participants performed the m-Ullevaal
9
group (average 88.61). This finding may be attributed to the lack of any financial
contribution from the participants on the one hand, and to the other with the nature of group-
based m-Ullevaal intervention. The socialization is another important component of group
based interventions that may especially benefit older patients suffered from CHF.
Table III presents the differences between m-Ullevaal protocol and the original Ullevaal
protocol. Based on these promising results, the m-Ullevaal protocol appears to be superior and
more beneficial group-based intervention compared to MICT in terms of FEC, LVEF,
mBPES, and QoL. It’s important to note that the overall benefits of the m-Ullevaal
intervention over count the corresponding of the MICT group. Further evidence and studies
such as the current study are needed for its solid clinical application.
Limitations of the study
Our study had some limitations that must be considered. A strong limitation of the present
study was the lack of long-term follow-up, in order to confirm the retention of the m-Ullevaal
effects on the FEC (6MWT, VO2 peak), (LVEF), mBPES, and QoL. This was due to lack of
additional funding required to cover all the expenditures related to follow-up process (i.e
salaries of the CR team, travel expenditures of the participants etc). Our study didn’t receive
any government funding for its implementation. As the clinical heterogeneity and origin of
CHF is wide, we didn’t cover the whole spectrum of the disease. We only included patients
suffering from ischemic cardiomyopathy, hypertensive heart failure and few patients with
idiopathic dilated cardiomyopathy. Another limitation was that we didn’t show control group
data, as the aim of the study was to compare two rehabilitation interventions in patients with
CHF in order to highlight the superiority of the m-Ullevaal protocol. The 6MWT was not
always supervised by same test-administrator, however, the testing was standardized and the
test administrators were trained. Given that this was a single-blind, prospective randomized
controlled trial, our investigative approach was acceptable.
The described problems and limitations are common experiences and occurrences within such
patient groups in real-life outpatient rehabilitation settings.
Conclusions
In this trial the superiority of the group-based m-Ullevaal protocol among CHF patients in
parameters evaluating FEC, LVEF, mBPES, and QoL in a short-term of intervention (12
weeks) was highlighted. These clinical benefits may encourage the PRM physicians involved
in CR to apply this intervention in rehabilitation of patients with CHF. Despite the promising
results of this group-based intervention, further research and evidence are needed.
NOTES
Confilcts of interest: The authors declare that there is no conflict of interest with any financial
organization regarding the material discussed in the manuscript.
Funding: This research did not receive any specific grant from funding agencies in the
public, or commercial, or not-profit sectors.
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TITLES OF TABLES
Table I.—Baseline demographic and clinical characteristics of participants.
TABLE II. —FEC (6MWT, VO2 peak), (LVEF), mBPES, QoL and Compliance in m-Ullevaal
and MICT groups at baseline and 12 weeks after both CR interventions (T2).
TABLE III. —Description of both CR interventions.
TITLES OF FIGURES
Figure 1.—CONSORT 2010 Flow diagram.
Figure 2. —The modified m-Ullevaal model. Panel A: The exercise intensity curve of m-Ullevaal
model.
Panel B: High-intensity exercises. Panel C: Exercises for flexibility and coordination.
Figure 3. —Changes in mean values for MLHFQ scores in CR groups at baseline (T1) and 12 weeks
after both CR interventions (T2).
TABLE I. — Baseline demographic and clinical characteristics of participants.

m-Ullevaal group MICT group
(N.=60) (N. =60) P value
Age (years) 63.65 ±6.71 63.82± 6.71 >0.05

Gender (men/women) 35/25 35/25 >0.05
Smoking status
Never 40 (66. 6%) 38 (63. 3%) >0.05
Ever 17 (28.3%) 1 8 (30.1%) >0.05
Current 3 (5.06%) 4 (6.6%) >0.05
NYHA class II/III 48/12 46/14 >0.05
Cause of CHF
Coronary artery disease 37 (61.6%) 36 (60%) >0.05
Hypertension 15 (25%) 16 (26.7%) >0.05
Cardiomyopathy 8 (13.4%) 8 (13.3 %) >0.05
LVEF 35. 88±2.3 36.03±2 >0.05
HR (beats/min) 62. 89±6. 08 63.05±4.8 >0.05
SBP (mm Hg) 121.05±8.8 121.08±7 >0.05
DBP (mm Hg) 75. 92±6.8 77.97±6.2 >0.05
6MWT (m) 440.58±39.7 442.90± 42.5 >0.05
mBPES 6.60±0.64 6.42±0.62 >0.05
VO2 peak 13.49±3.7 12.51±3. 5 >0.05
MLHFQ score 36.88±5.1 37.40±7.7 >0.05
Data presented as mean ± SD or number of patients (percent).
MICT: moderate intensity continuous training; CHF: Chronic heart failure; LVEF: Left ventricular ejection
fraction; HR: Heart Rate; SBP: Systolic Blood Pressure; DBP: Diastolic Blood Pressure; 6MWT: six-minute
walk test; mBPES: modified Borg’s Perceived Exertion Scale; VO 2peak: peak oxygen uptake; MLHFQ:
Minnesota living with the Heart Failure Questionnaire.
TABLE II.—FEC (6MWT, VO2 peak), (LVEF), mBPES, QoL and Compliance in m-Ullevaal and MICT groups at baseline (T1) and 12 weeks after
both CR interventions (T2).
CR Groups
m-Ullevaal group MICT group P value
(N. =60) (N. =60)
Variable Baseline (T1) Follow up % change P Baseline (T1) Follow up % change P

(T2) (95% CI) (T2) (95% CI)
6ΜWT (m) 440.58±39.79 513.38±37.73 16.86±6.43 <0.001 442.90±42.53 489.32±43.45 10.58±2.91 <0.001 <0.001
(15.20÷18.52) (9.83÷11.33)
VO2 peak 13.49±3.78 16.97±3,65 29.16±21.77 <0.001 12.51±3.56 14.53±3.09 19.68±21.69 0.001 <0.001
(24.99÷34.88) (14.57÷24.94)
mBPES 6.60±0.64 4.62±0.61 -29.79±8.88 <0.001 6.42±0.62 4.73±0.66 -25.71±11.29 <0.001 <0.001
(-32.58÷-21.17) (-29.45÷-22.40)
LVEF 35.88±2.30 40.68±2.32 13.44±2.08 < 0.001 36.03±2.03 39.80±2.11 10.48±1.50 <0.001
(12.91÷13.98) (10.10÷10.87) <0.001
MLHFQ 36.88±5.19 29.80±5.37 -19.46±6.04 <0.001 37.40±7.73 35.65±7.80 -6.41±4.23 <0.001
(-20.63÷ -18.02) (-7.03÷-5.26) <0.001
Compliance 88.61±6.59 87.22±7.31 >0.05
(%) (86.91÷90.31) (85.93÷89.11)
Data presented as mean ± SD; *P values are related to the % change.6MWT: six-minute walk test; VO2peak: peak oxygen uptake; mBPES: modified Borg’s Perceived
Exertion Scale; LVEF: Left ventricular ejection fraction; MLHFQ: Minnesota Living with the Heart Failure Questionnaire.
TABLE III. — Description of both CR interventions.
Variable Ullevaal m- Ullevaal

Duration 16 weeks 12 weeks
Number of included subjects in subgroups 8-12 5-8

Duration of each training session 50 min 40 min
mBPES Original (6-20) Modified (0-10)
Strength exercises included Moderate intensive intervals Moderate & high intensive intervals
HR max High intensive intervals High intensive intervals
(90-95%) (90%)
Moderate intensive intervals (50-60%) Moderate intensive intervals (70%)
Music Yes Yes

Number of counseling sessions 32 12
Duration of each counseling session 15-30 min 40 min
mBPES: modified Borg’s Perceived Exertion Scale; HR max: Maximum Heart Rate.

Group-Based Cardiac Rehabilitation Interventions. A Challenge For Physical and Rehabilitation Medicine Physicians: A Randomized Controlled Trial

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European Journal of Physical and Rehabilitation Medicine

EDIZIONI MINERVA MEDICA

Group-based cardiac rehabilitation interventions. A

European Journal of Physical and Rehabilitation Medicine 2020 Jan 23

Article type: Original Article

© 2020 EDIZIONI MINERVA MEDICA

Article first published online: January 23, 2020

Subscription: Information about subscribing to Minerva Medica journals is online at:

EDIZIONI MINERVA MEDICA

Group-Based Cardiac Rehabilitation Interventions. A Challenge for Physical and

Rehabilitation Medicine Physicians: a randomized controlled trial

Running Title: Group-based cardiac rehabilitation a challenge

Jannis V.PAPATHANASIOU1, Ivo PETROV2, Maria P. TOKMAKOVA3, Donka

D.DIMITROVA4, Liubomir SPASOV 5, Nigyar S. DZHAFER 6, Dorothea

TSEKOURA7, Yannis DIONYSSIOTIS 8, Arthur S. FERREIRA9, Agnaldo J.LOPES 9,

Eugenia ROSULESCU 10, Calogero FOTI 11

Institutional affiliations and locations:

Medicine, Medical University of Plovdiv, Bulgaria, Department of Kinesitherapy, Medical

Medical University of Plovdiv, Bulgaria; 4Department of Health Management and Health

Rehabilitation Center, Athens, Greece; 9Rehabilitation Sciences Post-graduate Program,

Translational Medicine, Tor Vergata University, Rome, Italy.

Corresponding author: Jannis Papathanassiou, MD, PhD, Department of Medical Imaging,

Sofia, Bulgaria, E-mail: giannipap@yahoo.co.uk

BACKGROUND: In recent decades, many studies are focused on different training

training (HIAIT) has been considered as an alternative approach to moderate-intensity

Ullevaal) compared to the moderate-intensity continuous training (MICT), also to encourage

in routine cardiac rehabilitation (CR) practice.

DESIGN: А single-blind, prospective randomized controlled trial.

SETTING: Medical Center of Rehabilitation and Sports Medicine, Plovdiv, Bulgaria

outpatients were enrolled.

participants performed m-Ullevaal protocol achieved a greater improvement compared to

those performed MICT (P<0.001).

CLINICAL REHABILITATION IMPACT: Group-based HIAIT interventions can be

rehabilitation (CR) programs with varying recommendations in specific guidelines across

functions.2 Before prescribing an appropriate CR program, assessment focused on functioning

patients with CHF, even among individuals having an implantable cardioverter-defibrillator or

mentioned protocol is consisted of 3 high intensity intervals and 2 moderate intensity

intervals. 9 During 3 high intensity intervals, subjects are encouraged to achieve 15 to 18 on

living (ADL) resulting in poor QoL.11 10

HRQoL, compared to with other chronic diseases as well as healthy population.13

Materials and methods

This prospective randomized controlled trial with a single-blinded (assessor-blinded), design

months) prior to participation.

200/110 mmHg, six-minute walking distance (6MWD) >550 m; hypertrophic obstructive

limited ability to cooperate.

group, using a stratified block randomization (www.randomization.com) by age, gender,

Our study was performed by a multiprofessional CR team, composed of PRM physicians,

cardiologist, physiotherapists, exercise physiologist, rehabilitation nurse, occupational

and QoL. Demographic data were collected.

Six-minute walk test - (6MWT)

predictor of morbidity and mortality in many clinical conditions. 19

Cardiopulmonary exercise testing-(CET)

PRM physician and exercise physiologist of multiprofessional CR team.

Left ventricular ejection fraction - (LVEF)

of CR team, using dedicated echocardiographic equipment (Vivid 7, General Electric, Boston,

MA, USA), according to the recommendations of the American Society of Echocardiography.

Quality of Life - (QoL)

greater perception of severity and intrusiveness of heart failure related symptoms.

group assignment at baseline (T1) and after 24 training sessions (T2).

The m-Ullevaal protocol is a modified group-based HIAIT intervention consisting of three

extended up to 18 weeks. The benefits of group-based CR interventions in improvement of

provided by health professionals (i.e. occupational therapist, clinical psychologist, social

worker, rehabilitation nurse, and dietician) of the multiprofessional CR team.