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SHORT-TERM AND LONG-TERM

FEASIBILITY, SAFETY, AND EFFICACY


OF HIGH-INTENSITY INTERVAL
TRAINING IN CARDIAC
REHABILITATION
The FITR Heart Study Randomized Clinical Trial
Introduction
Cardiac rehabilitation (CR)  essential component in the
secondary prevention of coronary artery disease (CAD)

Proven reduction in cardiovascular and all-cause mortality

Exercise plays an important role as cardiorespiratory fitness


exerts the largest influence on cardiovascular disease prognosis
in this population
Introduction
High-intensity interval training (HIIT) has shown
superior improvements in VO2 peak compared with
moderate-intensity continuous training (MICT) in
patients with CAD.

Current international CR guidelines dictate a need for


further investigation into the feasibility, safety, and long-
term adherence associated with HIIT
Aim
Primary Secondary
• To compare the efficacy of HIIT • The efficacy of HIIT compared
with MICT for improving VO2 with MICT for improving VO2
peak during a 4-week supervised peak following a supervised CR
hospital-based CR program. program over 12-month follow-up
and whether implementation of a
HIIT program was safe and
feasible, promoted greater exercise
adherence, modified
cardiovascular risk factors, and
improved quality of life.
METHODS
Patient Selection and Allocation
Inclusion:
angiographically Patients were
proven CAD, age further excluded
18 to 80 years, Participants All participants from the study if
eligible to underwent underwent a abnormal results
participate in the baseline testing medically identified from the
hospital CR baseline CPET
before 1:1 supervised resulted in further
program randomization cardiopulmonar angiography or
Exclusion: to either HIIT or y exercise test recommended
absolute or MICT (CPET) exclusion by the
relative patients’ treating
contraindications physician
to exercise testing
Outcome Measures
Primary outcome • Measured by CPET at baseline and 4 weeks
(VO2 peak) • Further testing occurred at 3, 6, and 12 months

Safety • Assessed continuously throughout the study period

Adherence to the • Assessed as 70% attendance or higher at the recommended number of


exercise sessions when training at the prescribed exercise intensity during
exercise protocol the exercise sessions

• Anthropometric measures, fasting blood markers, supine blood pressure,


habitual dietary intake, physical activity (by accelerometry), and
Other Data participant questionnaires related to feasibility, quality of life, and
exercise enjoyment
Exercise Protocols
The HIIT protocol involved 4 × 4-minute high-intensity intervals
corresponding to a rating of perceived exertion (RPE) of 15 to 18
on the Borg 6 to 20 scale, interspersed with 3-minute active
recovery intervals (RPE of 11 to 13)

The MICT protocol involved usual care exercise of 40-


minute moderate- intensity exercise at an RPE of 11 to 13

Participants were instructed to complete 3 sessions of their


allocated training per week (2 supervised and 1 home-based
session) during the 4-week CR program and then to continue
home-based training (at least 3 sessions per week of their
allocated training) for a further 11 months
CONSORT Flowchart
of Study Enrollment,
Allocation, and
Follow-up
Statistical Analysis
Baseline characteristics
Intention- to-treat
Sample size calculation and exercise adherence Sensitivity analyses
analyses
data
• Conducted for the • Using linear mixed • Compared using t tests • Conducted to account
primary outcome, the modelling were for continuous variables for medication changes
comparison of groups performed to investigate and Fisher exact test for
for change in VO2 peak the time and group categorical data
over a 4-week interaction effects for
supervised program, the supervised study
determined 80 period (baseline to 4
participants (40 per weeks) and 12- month
group) would be period (all time points)
sufficient to detect a 1–
metabolic equivalent
difference (3.5
mL/kg/min) between
groups with an SD of
4.75 mL/kg/min and a
power of 0.9 at an α of .
05
Result
3 of 96 participants 1 of 96 participants
(3%) were medically (1%) requiring
excluded following further coronary
baseline CPET intervention
96 participants were
recruited between
May 2016 and
November 2017 47 MICT DO : 8 (17%)
78 (84%) were male
93 randomized
and the mean (SD)
participants
age was 65 (8) years
46 HIIT DO : 12 (26%)

A total of 86 participants completed testing at 4 weeks for the primary outcome, including 43 in the HIIT group
and 43 in the MICT group; 69 completed testing at 12 months for VO2 peak, including 32 in the HIIT group and
37 in the MICT group.
Participant Characteristics
at Baseline
Medication
adjustments
throughout the
study period
Cardiorespiratory Fitness
Following the 4-week supervised program, VO2 peak increased by 10% with HIIT and 4% with MICT (mean
[SD] oxygen uptake: HIIT, 2.9 [3.4] mL/kg/min; MICT, 1.2 [3.4] mL/kg/ min; mean difference [MD], 1.7
mL/kg/min; P = .02)

Similar for VO2 peak normalized for lean body mass (mean [SD] oxygen uptake: HIIT, 4.1 [4.9] mL/kg/min
[10% improvement]; MICT, 1.0 [5.0] mL/kg/min [2% improvement]; MD, 3.1 mL/kg/min; P = .004)

After 12-month follow-up, participants in the HIIT and MICT groups showed similar improvement in VO2 peak
from baseline, with a 10% improvement in the HIIT group and a 7% improvement in the MICT group (mean
[SD] oxygen uptake: HIIT, 2.9 [4.5] mL/kg/min; MICT, 1.8 [4.3] mL/kg/min; MD, 1.1 mL/kg/min; P = .30)
Efficacy Results for Cardiorespiratory Fitness, Exercise Testing
Variables, Cardiorespiratory Risk Factors, and Quality of Life
Efficacy Results for Cardiorespiratory Fitness, Exercise Testing
Variables, Cardiorespiratory Risk Factors, and Quality of Life
Serious adverse events
Exercise Adherence
◦ Average training RPE was higher for HIIT compared with MICT (mean [SD] RPE: HIIT, 16.3 [1.3]; MICT, 12.4
[0.6]; P < .001), as was average training heart rate as a percentage of peak heart rate (mean (SD) percentage: HIIT,
87% [6]; MICT, 71% [8]; P < .001)
Adherence to exercise training protocols
Exercise Adherence
Exercise adherence was high during the initial supervised stage (HIIT,
39 of 44 [91%]; MICT, 39 of 43 [91%]; P > .99) and reduced over the
12-month study period (HIIT, 18 of 34 [53%]; MICT, 15 of 37 [41%]; P
= .35), with no differences between groups

After 6 months of home-based training, we observed a reduction in the


number of participants training at the prescribed intensity, with 15 of
39 participants in the MICT group (38%) exercising at a higher
intensity on their own accord and 9 of 37 participants in the HIIT
group (24%) exercising at a lower intensity
Exercise Adherence
◦ Based on adherence to attendance and intensity, per-protocol analysis showed
that HIIT was superior to MICT for improving VO2 peak at 12 months (HIIT,
5.2 [4.1] mL/kg/min [18% improvement]; MICT, 2.2 [4.1] mL/kg/min [8%
improvement]; MD, 3.0 mL/kg/min; P = .02)
Results
Feasibility
• Both HIIT and MICT reported high feasibility of the exercise protocols throughout
the study period
Additional Outcomes
• Following supervised training, there was a decrease in blood pressure after MICT
compared with HIIT for both systolic pressure and diastolic pressure
• There were no group differences for any other cardiovascular risk factors or
measures related to diet and physical activity
• All QoL domains improved over the study period, with no differences between
groups
Discussion

A 4-week supervised
The superior effect of
HIIT program improved Implementation of the
HIIT was not maintained
cardiorespiratory fitness HIIT protocol using RPE
long term, with similar
more than MICT without for exercise intensity was
improvements to MICT
adversely affecting feasible
at 12 months
patient safety
Discussion
The greater efficacy of HIIT for improving VO2 peak
compared with MICT during supervised training (MD,
1.7 mL/kg/ min) is similar to previous meta-analyses
reporting group differences of 1.5 to 1.6 mL/kg/min

Each 1 mL/kg/min improvement in VO2 peak during a


CR program has been associated with a 6% reduction in
hospital readmissions and 13% reduction in all-cause
mortality

At 12 months, both groups showed similar improvement


in VO2 peak; however, the MD between HIIT and MICT
of 1.1 mL/kg/min could be considered clinically
meaningful
Discussion

Greater reduction in
systolic and diastolic
blood pressure after short-
term MICT compared In patients with Similar to the findings by
with HIIT is in contrast to hypertension at baseline, Sosner et al, where HIIT
a recent meta-analysis both HIIT and MICT only reduced blood
reporting similar mean reduced systolic and pressure in those with
reductions in systolic (6 diastolic blood pressure initially elevated levels
mm Hg) and diastolic (4
mm Hg) pressures for
HIIT and MICT
Discussion
No deaths or cardiovascular events directly caused by the exercise interventions

One serious adverse event in the HIIT group occurred in relation to exercise training (postexercise
hypotension)

The treating physician diagnosed the cause as diuretic-induced dehydration

These findings are consistent with previous trials, which consistently demonstrate a favourable safety profile
of HIIT programs

In the current study, medical exclusion following baseline CPET (3%) and further coronary intervention (1%)
were very low
Discussion
During unsupervised training, a large proportion of participants
in the MICT group (38%) exercising at a higher intensity (RPE
of 15 or greater), indicating that prescribing exercise at
moderate intensity is potentially not challenging enough for
some patients

HIIT demonstrated a superior effect on VO2 peak compared


with MICT, with a mean group difference of 3.0 mL/kg/min
Limitations
Patients were recruited from a
single center, there were low rates There is limited published
Optimization of drug therapy was
of female patients and patients evidence that patients targeting an
at the discretion of the treating
with left ventricular dysfunction, RPE range will inherently increase
physician
type 2 diabetes, and a history of their workload over time
tobacco smoking

The provision of heart rate


monitors only for participants in
Some participants in the MICT
the HIIT group during the initial 3
There were a number of patients group exercised more frequently
months could have enhanced
who failed to maintain adherence and at higher intensities than
exercise adherence, motivation,
to the prescribed exercise program prescribed, increasing the
and achievement of intended heart
likelihood of type 2 error
rate targets during the initial stages
of home-based exercise
Conclusion
◦ HIIT is superior to MICT for improving cardiorespiratory fitness during a 4-
week hospital- based CR program in patients with CAD but offers similar
improvement to MICT at 12 months.
◦ The HIIT protocol was safe, feasible, and successfully implemented in a home-
based environment with similar adherence to MICT over 12 months.
◦ Further improvement in cardiorespiratory fitness after 12 months in patients
undertaking HIIT was limited to those with good exercise adherence.
◦ These findings support the inclusion of HIIT in CR programs as an alternative
or an adjunct to standard moderate-intensity exercise, allowing for prescription
based on patient goals, preferences, and capabilities.
CRITICAL
APPRAISAL
ARE THE RESULTS OF THE
TRIAL VALID? (INTERNAL
VALIDITY)
PICO Analysis

P A total of 96 participants with angiographically proven CAD aged


18 to 80 years were enrolled, and 93 participants were medically Yes
(Population/patients/clinical cleared for participation following a cardiopulmonary exercise test.
problem)
PICO Analysis

I (intervention, Prognostic A 4 × 4-minute HIIT program or a 40-minute MICT program


(usual care). Patients completed 3 sessions per week (2 supervised
Yes

factors, or Exposure) and 1 home-based session) for 4 weeks and 3 home-based sessions
per week thereafter for 48 weeks.
PICO Analysis

C (Comparison or Of 93 randomized participants, 46 were randomized to HIIT and 47


to MICT. Dropout rates between HIIT (12 of 46 [26%]) and MICT
Yes

Intervention) (8 of 47 [17%]) were not different over 12- month follow-up (P = .


32).
PICO Analysis
O (Outcome ) Primary outcome  change in VO2 peak during the Yes
cardiopulmonary exercise test from baseline to 4 weeks. Further
testing occurred at 3, 6, and 12 months.
Secondary outcomes  feasibility, safety, adherence,
cardiovascular risk factors, and quality of life.
Was the assignment of patients to
treatments randomised?
◦ After providing consent, participants underwent baseline testing before
1:1 randomization to either HIIT or MICT (usual care)

Answer = YES
Were the groups
similar at the start
of the trial?
Answer = YES
Aside from the allocated treatment,
were groups treated equally?

Answer = YES
Were all patients who entered the
trial accounted for? And were they
analysed in the groups to which
they were randomised?

Answer = YES
Were measures objective or were the patients and clinicians
kept “blind” to which treatment was being received?

◦ In this study it is not stated


whether this study is blinded
or not

Answer = NO
WHAT WERE THE
RESULTS?
How large was the treatment effect?

HIIT demonstrated a superior effect on VO2 peak compared


with MICT, with a mean group difference of 3.0 mL/kg/min
How precise was the estimate of the
treatment effect?
Conducted for the primary outcome, the
comparison of groups for change in VO2
peak over a 4-week supervised program,
determined 80 participants (40 per
group) would be sufficient to detect a 1–
metabolic equivalent difference (3.5
mL/kg/min) between groups with an SD
of 4.75 mL/kg/min and a power of 0.9 at
an α of .05
EXTERNAL
VALIDITY
Will the results help me in caring for
my patient?
Yes, although this study was conducted on a population of a developed country
with a high socioeconomic status
THANK YOU

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