Annals of Physical and Rehabilitation Medicine 63 (2020) 181–188

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Original article

Limited effect of a self-management exercise program added to spa

therapy for increasing physical activity in patients with knee
osteoarthritis: A quasi-randomized controlled trial
Chloé Gay a, Candy Guiguet-Auclair a, Nicolas Coste b, Nathalie Boisseau c,
Laurent Gerbaud a, Bruno Pereira d, Emmanuel Coudeyre d,*
a
Service d’épidémiologie et de santé publique, Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut Pascal,
63000 Clermont-Ferrand, France
b
Service de Médecine Physique et de Réadaptation, CHU de Clermont Ferrand, INRA, Université Clermont Auvergne, Clermont Ferrand, France
c
Laboratoire des Adaptations Métaboliques à l’Exercice en condition Physiologiques et Pathologiques (AME2P), Université Clermont Auvergne, Clermont-
Ferrand, France
d
Délégation Recherche Clinique et Innovation, CHU de Clermont Ferrand, Université Clermont Auvergne, Clermont Ferrand, France

A R T I C L E I N F O A B S T R A C T

Article history: Background: The efficacy of spa therapy in osteoarthritis (OA) has ever been demonstrated, with a good
Received 22 October 2018 level of evidence for pain and disability. The effect of a self-management program with spa therapy on
Accepted 31 October 2019 physical activity (PA) level has never been demonstrated.
Objective: This study aimed to assess, at 3 months, the effectiveness of 5 sessions of a self-management
Keywords: exercise program in patients with knee OA (KOA) who benefit from 18 days of spa therapy and received
Physical activity level an information booklet (on proposed physical exercises) on improvement in at least one PA level.
Exercise
Methods: This was an interventional, multicentre, quasi-randomized controlled trial with a cluster
Osteoarthritis
Education
randomized design (1-month period). People 50 to 75 years old with symptomatic knee OA were included in
Self-management 3 spa therapy centres in France (Bourbon Lancy, Le Mont Dore, Royat). Both groups received conventional spa
therapy sessions during 18 days and an information booklet on the benefits of PA practice for KOA. The
intervention group additionally received 5 self-management exercise sessions. The main outcome was
improvement in at least one PA level according to the International Physical Activity Questionnaire (IPAQ)
short-form categorical score (low to moderate or high, or moderate to high) at 3 months. Secondary outcomes
were the evolution of PA (MET-min/week), disability, pain, anxiety, depression, self-efficacy, fears and beliefs
concerning KOA, barriers to and facilitators of regular PA practice, consumption of painkillers and adherence to
physical exercise program at 3 months. Assessors but not participants or caregivers were blinded.
Results: In total, 123 patients were randomized, 54 to the intervention group and 69 to the control group.
Considering the main outcome, at 3 months, 37% of patients in the intervention group showed
improvement in at least one PA level according to the IPAQ categorical score versus 30.4% in the control
group (P = 0.44). In the intervention group, 13 (24.1%) patients showed improvement from low to
moderate PA level (vs. 8 [11.6%] in the control group), 2 (3.7%) from low to high (vs. 2 [2.9%]) and 5 (9.3%)
from moderate to highvs. 11 [15.9%]). Both intervention and control groups showed increased IPAQ
continuous scores (MET-min/week) at 3 months, although not significantly. HAD anxiety and depression
scores were significantly reduced in the intervention group (P = 0.001 and P = 0.049, respectively) and
the perception of PA was better in the intervention than control group for motivation and barriers scores
(P = 0.019 and P = 0.002, respectively).
Conclusions: This study showed the lack of impact of a short self-management program on PA level in
addition to 18-day spa therapy for KOA, but both intervention and control groups showed improved PA level.
C 2019 Elsevier Masson SAS. All rights reserved.

* Corresponding author.
E-mail address: ecoudeyre@chu-clermontferrand.fr (E. Coudeyre).

https://doi.org/10.1016/j.rehab.2019.10.006
1877-0657/
C 2019 Elsevier Masson SAS. All rights reserved.
182 C. Gay et al. / Annals of Physical and Rehabilitation Medicine 63 (2020) 181–188
1. Introduction
Knee osteoarthritis (KOA) affects more than 250 million people
worldwide [1]. According to the World Health Organization (WHO),
chronic disease will be the main source of disability in 2020. Lower-
limb osteoarthritis (OA) contributes to functional limitations and
loss of autonomy by reducing the activities of older people.
International practice guidelines prioritize the association of
non-pharmacological and pharmacological treatment [2,3]. Non-
pharmacological interventions include exercise programs, OA self-
management with the necessary knowledge about the nature of
the disease, and the objectives of treatment/lifestyle changes and
losing weight if necessary. Exercise programs include specific
exercises focused on the lower limb (strength and/or endurance
training, range of motion) and an increase in general physical
activity (PA) level [4].
The peak muscle mass is reached at about age 30 years and
decreases faster after age 60 [5]. In the absence of regular PA,
muscular strength is reduced. To favor knee stabilization and limit
OA development, strengthening quadriceps and peripheral mus-
cles of the knee joint is essential [5]. Moreover, a target muscle
strength can limit joint malalignment and minimize the load on
the extensor apparatus. Active and passive mobilization of the joint
allows for gains in range of motion. Endurance training aims to
alleviate pain and disability and improve quality of life [6].
PA level is lower in people with OA than the general population
[7,8]. Comorbidities and risk of death are increased with OA. People
with more disease are less active [9]. According to Rosemann et al.
[10], the level of PA for people with knee OA (KOA) using the
International Physical Activity Questionnaire (IPAQ) categorical score
was low, moderate and high for 52.8%, 28.5% and 8.6%, respectively.
Reduced PA activity increases with age, body mass index (BMI) and
sex (women). PA practice may have 2 main effects: reducing the
impact of comorbidities and alleviating KOA symptoms.
However, adherence to non-pharmacological treatments is still
incomplete [11,12]. To be fully effective, endurance and resistance
training programs must be accompanied by ways to promote
adherence [13]. Among these measures, self-management educa-
tion, centred on exercise, can improve adherence to guidelines [14].
The efficacy of spa therapy in OA has been demonstrated, with a
good level of evidence for pain and disability [15,16], but the effect
on PA level with or without a self-management exercise program
has never been demonstrated. Many people with OA, with varied
phenotypes, attend spa therapy resorts in Europe. Spa therapy has
a therapeutic effect and also contributes to secondary prevention.
It allows for a spatial and temporal break, with the assistance of
medical and multidisciplinary medical staff. This context can be
helpful for managing lifestyle modifications and could be an
opportunity for a self-management education exercise program.
However, the synergistic effect of a self-management exercise
program associated with spa therapy for KOA remains to be
demonstrated. We hypothesized that a self-management exercise
program could potentiate and bring complementary benefits to
spa therapy. This study aimed to assess, at 3 months, the
effectiveness of 5 sessions of a self-management exercise program
in patients with KOA who benefit from 18 days of spa therapy and
received an information booklet (on proposed physical exercises);
we assessed improvement in at least one PA level according to the
IPAQ short-form categorical score [17] (low to moderate or high, or
moderate to high). Secondary objectives were to assess the change
from baseline to 3 months in PA measured in MET-min/week,
disability, pain, anxiety, depression, self-efficacy, fears and beliefs
concerning KOA, barriers to and facilitators of regular PA practice,
consumption of painkillers, and adherence to physical exercises
proposed to be performed.
2. Methods
2.1. Trial design
This was an interventional, multicentre, quasi-randomized
controlled trial with a cluster randomized trial for which time
periods (1 month) were randomized. This study was conducted in
3 spa therapy resorts in France.
The study protocol was published [18] and approved by the
medical ethics committee of Sud-Est 6, (no. 2015/CE38) and
registered at ClinicalTrials.gov (NCT02598804). The trial was
conducted in compliance with both Good Clinical Practices and
the Declaration of Helsinki. All patients provided written consent
to participate in the study after being informed in detail about the
study procedures. This trial was conducted in accordance with the
CONsolidated Standards Of Reporting Non Pharmacological Trials
(CONSORT) [19].
2.2. Participants
Men and women aged 50 to 75 years were recruited on a
volunteer basis among the usual people attending 3 spa therapy
centres involved in treating rheumatic diseases in the French
Auvergne region (Bourbon-Lancy, le Mont Dore and Royat spa
centres). People were eligible if they:
 gave their written consent to participate;
 had symptomatic KOA according to the classification criteria of
the American College of Rheumatology [20], as confirmed by
physical examination and plain radiography, with Kellgren and
Lawrence score I to IV.
We excluded people with:
 behavioral and comprehension disorders and thus not able to be
assessed;
 a high PA level defined by the IPAQ Short Form questionnaire
categorical score [21];
 unstable angina or decompensated cardiac insufficiency.
These eligibility criteria were checked by the physician in
charge of the patient.
2.3. Interventions
Patients were randomly assigned to the intervention or control
group. Both groups received 18 conventional spa therapy sessions
during 3 weeks and an information booklet on the benefits of PA
practice with KOA and a description of exercises that could be
practiced (Appendix: Card 1). The intervention group additionally
received 5 self-management exercise sessions of 1.5 hr each
(education, endurance and resistance training, range of motion).
Each conventional spa therapy session of 1 hr comprised a
mineral hydrojet session at 37 8C for 15 min, thigh massage under
mineral water at 38 8C by a physiotherapist for 10 min, the
application of mineral-matured mud at 45 8C to the knees for
15 min, and supervised general mobilisation in a collective mineral
water pool at 32 8C per groups of 8 patients for 15 min.
The interventions were designed by a multidiscplinary steering
committee, standardized and reproducible for the 3 centres. Each
self-management exercise session consisted of 45 min of self-
management education (Appendix: Box 1) and 45 min of PA
practice (Appendix: Box 2). This exercise program aimed to allow
people to understand the importance of physical exercise practice
and learn when, where and how to practice exercise, in order to
 C. Gay et al. / Annals of Physical and Rehabilitation Medicine 63 (2020) 181–188
adapt their PA practice to their phenotype and to integrate it in their
daily lives in the long term. For each session, a specific objective and
operational objectives were defined, linked to criteria and
indicators (Appendix: Box 1). The exercise program was tailored
to each participant and was supervised by the same experienced PA
instructor in groups of 5 to 7 participants [18], in each centre.
2.4. Outcomes
Self-administered questionnaires were used, and outcomes
were collected at baseline and 3 months after the intervention
(mailed questionnaires). If needed, the research officer followed up
by telephone.
The primary outcome was the evolution of PA level defined by
the IPAQ categorical score [10,21], at 3 months [15] after the
intervention, that is, the proportion of participants showing
improvement from low to moderate or high PA level or from
moderate to high PA level.
Secondary outcomes [22] were IPAQ continuous scores in MET-
min/week (vigorous, moderate, walking and total activity);
disability assessed by the Western Ontario and McMasters
Osteoarthritis Index (WOMAC) function subscale [23]; pain severity
over the past 24 hr and most important pain during the last month
assessed by a visual analog scale (VAS) scored from 0 (no pain) to 10
(very severe pain); anxiety and depression assessed by the Hospital
Anxiety and Depression (HAD) scale [24]; self-efficacy assessed by
the Arthritis Self-Efficacy Scale (ASES) [25,26]; fears and beliefs
concerning KOA assessed by the Knee Osteoarthritis Fears and
Beliefs Questionnaire (KOFBeQ) [27]; barriers to and facilitators of
regular PA practice assessed by the Evaluation of the Perception of
Physical Activity (EPPA) [28]; and consumption of painkillers.
Adherence to the booklet exercise program was assessed by the
practice and frequency of booklet exercises at 3 months.
2.5. Sample size
According to previous works presented in a systematic
literature review [13], we estimated that for a two-sided type I
error at 5%, a sample of 65 patients per randomized group would
provide 80% statistical power to detect an absolute difference of
20% (25% in the intervention group vs. 5% in the control group) for
the primary outcome: the proportion of participants with
improvement in at least one IPAQ class (low to moderate or high,
or moderate to high). Finally, we aimed to include 142 patients
(71 per group) to account for lost to follow-up (estimated at 10%).
2.6. Randomisation
We used a cluster randomized trial for which time periods
(1 month) were randomized, a quasi-randomisation method
[29,30]. The randomisation list was established by the methodol-
ogist in charge of the project before starting the trial. The
randomisation was conducted to equilibrate population groups by
stratified randomisation blocks by centre, which allowed for
controlling the eligibility of participants and communicating to
each of them some information relative to randomisation from the
investigator and eventually other correspondents. A document
detailing the procedures for randomisation was kept confidential.
Participants were enrolled by the research coordinator and
assigned to intervention and control groups by time periods by
the statistician in charge of the randomisation.
2.7. Blinding
Participants were mixed with the general public in the center.
The spa therapists were not aware of which patients took part in
183
the trial. The researchers who collected the self-reported
questionnaires were independent from the spa center and blinded
to the randomisation group.
2.8. Statistical methods
Statistical analyses were performed with SAS v9.4 and
P < 0.05 was considered statistically significant.
Intention-to-treat analysis was used for the primary outcome.
The method of the maximum bias (last observation carried
forward, here baseline) was used for the imputation of missing
data for the IPAQ categorical score at 3 months. Secondarily, a per-
protocol analysis was considered. In addition, concerning the IPAQ
short-form questionnaire, when the participant mentioned a
number of days, hours or minutes for an activity without checking
‘‘yes’’ or ‘‘no’’ to intense, moderate or walking category practice, a
‘‘yes’’ response was imputed for this question. If the participant did
not mention the practice of an activity or number of days, hours or
minutes, a ‘‘no’’ response was imputed for this question. Groups
were compared with a logistic mixed model to take into account
spa centre and period (according the cluster randomized design) as
random effects.
Normality was studied for the secondary continuous endpoints
by the Shapiro-Wilk test and homoscedasticity by the Fisher–
Snedecor test. Log transformations were used if necessary.
Secondary endpoints were compared between groups with per-
protocol analysis, using a generalized linear mixed model
considering the randomisation group and baseline values as
independent parameters (fixed effects), as suggested by Vickers
and Altman [31], and considering spa centre and period as random
effects. For each secondary endpoint, Cohen’s d effect size was
estimated.
3. Results
3.1. Participants
From August 2015 to September 2016, 170 patients were
assessed for eligibility in the 3 spa centers and 123 patients were
randomized, 54 to the intervention group and 69 to the control
group (Fig. 1). The follow-up period was 3 months after inclusion:
52 (96.3%) patients in the intervention group and 54 (78.3%) in the
control group completed the study protocol.
Characteristics of the 2 groups at baseline are summarized in
Table 1. The groups did not differ in sex, age, family situation, BMI,
OA duration, Kellgren and Lawrence stage, WOMAC function, pain
during the last 24 hr, most intense pain during the last month,
comorbidities and other painful joints. The 17 patients lost to
follow-up at 3 months did not significantly differ from the others
concerning these baseline data.
3.2. Primary outcome
Data for 54 patients in the intervention group and 69 patients in
the control group were available for the intention-to-treat primary
analysis. Two patients in the intervention group and 15 in the
control group were lost to follow-up at 3 months (Fig. 1).
Consequently 52 patients (51 for the primary outcome) and
54 patients (52 for the primary outcome) in the intervention and
control groups, respectively, remained for the per-protocol
analysis.
In the intention-to-treat analysis, the proportion of participants
showing improvement at 3 months in at least one PA level
according to the IPAQ categorical score was 37% in the intervention
group and 30.4% in the control group (P = 0.441). In the
184 C. Gay et al. / Annals of Physical and Rehabilitation Medicine 63 (2020) 181–188
Fig. 1. CONSORT flow diagram of participants.
intervention group, 13 (24.1%) patients showed improvement from
low to moderate PA level (vs. 8 [11.6%] in the control group), 2
(3.7%) from low to high (vs. 2 [2.9%]) and 5 (9.3%) (vs. 11 [15.9%])
from moderate to high.
In the per-protocol analysis, the proportion of participants
showing improvement at 3 months in at least one PA level was
39.2% in the intervention group and 40.4% in the control group
(P = 0.904).
3.3. Secondary outcomes
Both intervention and control groups showed increased IPAQ
continuous scores at 3 months, with no significant difference
between groups (Fig. 2). The effect sizes between groups for the
difference between baseline and 3 months were very small: 0.07
(95% confidence interval [CI] 0.43; 0.56) for moderate activity,
0.13 ( 0.33; 0.59) for walking and 0.17 ( 0.24; 0.57) for total
activity (Table 2).
According to the World Health Organization (WHO), 300 min/
week of PA is recommended for additional health benefits [32]. For
both groups at baseline, 44.7% had total PA greater than WHO
recommendations. At 3 months, 61.7% had total PA greater than
WHO recommendations. This difference between baseline and
3 months was significant (P = 0.014). The improvement at 3 months
was significant in the intervention group (P = 0.033) but not in the
control group (P = 0.180).
At 3 months, disability was more reduced in the intervention
group, with no significant difference between groups (Table 3). The
effect size for WOMAC function score was very small ( 0.16 [95%
CI 0.61; 0.29]).
Pain during the last 24 hr and most intense pain during the last
month were more reduced in the intervention than control group
(Table 3), with no significant difference (P = 0.660 and P = 0.127,
respectively). The effect size was higher for the most intense pain
during the last month ( 0.38 [95% CI 0.78; 0.03]) than for pain
during the last 24 hr ( 0.08 [ 0.47; 0.32]).
Anxiety and depression were reduced at 3 months in the
intervention but not control group (Table 3). The differences in
evolution of HAD scores were significant between groups
(P = 0.001 for anxiety and P = 0.049 for depression). The effect
size was medium and higher for anxiety than depression ( 0.65
[95% CI 1.04; 0.25] vs. 0.36 [ 0.75; 0.03]).
The groups did not differ in evolution of self efficacy (Table 3).
The effect size between groups for the difference between baseline
 C. Gay et al. / Annals of Physical and Rehabilitation Medicine 63 (2020) 181–188 185

Table 1
Demographic and clinical characteristics of patients with osteoarthritis (OA) at baseline.

Intervention group (n = 54) Control group (n = 69) P-value

Sex, n (%) 0.75

Male/Female 9 (16.7) 13 (18.8)
Female 45 (83.3) 56 (81.2)
Age (years), mean (SD) 66.6 (6.4) 64.7 (7.1) 0.17
Family situation 0.09
Single 11 (20.8) 24 (34.8)
In a couple 43 (79.2) 45 (65.2)
BMI (kg/m2), mean (SD) 28.7 (4.4) 29.2 (5.6) 0.93
Obesity (BMI > 30 kg/m2), n (%) 20 (37.0) 24 (35.3) 0.84
OA duration (years), mean (SD) 12.1 (7.7) 11.2 (7.7) 0.49
Kellgren and Lawrence stage, median 3 3
WOMAC function (0-100), mean (SD) 32.0 (16.8) 38.4 (18.9) 0.09
Pain during the last 24 hours (0- 10), mean (SD) 4.9 (2.1) 5.0 (1.9) 0.90
Most intense pain during the last month (0- 10), mean (SD) 6.4 (2.6) 6.4 (2.0) 0.55
Comorbidities, n (%)
Diabetes 4 (7.4) 5 (7.2) 1.00
Hypertension 21 (38.9) 26 (37.7) 0.89
Gastrointestinal bleeding 1 (1.9) 6 (8.7) 0.13
Anxiety/depression 4 (7.4) 11 (15.9) 0.15
Physical impairment limiting activity 5 (9.3) 4 (5.8) 0.50
Cardiovascular disease 6 (11.1) 8 (11.6) 0.93
Number of comorbidities, mean (SD) 1.2 (1.4) 1.3 (1.3) 0.55
Other painful joint, n (%)
Lumbar spine 40 (74.1) 45 (65.2) 0.29
Cervical spine 32 (59.3) 38 (55.1) 0.64
Shoulders 27 (50.0) 33 (47.8) 0.81
Hands 29 (53.7) 37 (53.6) 0.99
Hips 25 (46.3) 25 (36.2) 0.26
Foot 23 (42.6) 21 (30.4) 0.16

WOMAC: Western Ontario and McMasters Osteoarthritis Index.

Fig. 2. Evolution of the International Physical Activity Questionnaire continuous scores (MET-min/week) from baseline to 3 months.

and 3 months was 0.31 (95% CI 0.07; 0.70) for ASES pain, 0.17
( 0.55; 0.22) for ASES function and 0.32 ( 0.06; 0.71) for ASES
other symptoms.
Fears and beliefs concerning KOA were reduced in the
intervention group for all KOFBeQ scores but not in the control
group (Table 3). The differences in the evolution of scores were not
significant between the 2 groups. The higher effect size was for
KOFBeQ physicians score ( 0.47 [ 95% CI 0.87; 0.07]).
The perception of PA was better at 3 months in the intervention
group and poorer in the control group (Table 3). The differences in
evolution was significant between groups for EPPA motivation and
barriers scores, with effect sizes of 0.40 (95% CI 0.01; 0.80) and
0.54 (0.12; 0.95), respectively.
Consumption of painkillers had decreased at 3 months in both
groups, with no significant difference between groups (P = 0.688).
Adherence to the booklet exercise program was better in the
intervention than control group. People in the intervention group
practiced more physical exercises proposed in the booklet than did
people in the control group (P < 0.001). Among people who
practiced these exercises, the frequency of practice did not
186 C. Gay et al. / Annals of Physical and Rehabilitation Medicine 63 (2020) 181–188

Table 2
Evolution of the International Physical Activity Questionnaire (IPAQ) continuous scores from baseline to 3 months and difference between intervention and control groups.

IPAQ scores (MET-min/week) for Intervention group (n = 52) Control group (n = 54)

Baseline 3 months Baseline 3 months D(3months–baseline) between groups a Between groups

at 3 months
b
Mean (SD) Mean (SD) Mean (SD) Mean (SD) Absolute difference ES (95% CI) P-value
(95% CI)

Moderate activity 658.8 (448.3) 1003.0 (924.1) 600.7 (446.0) 889.3 (763.0) 55.6 ( 353.9; 465.1) 0.07 ( 0.43; 0.56) 0.657
Walking 654.2 (555.1) 862.4 (777.2) 855.6 (586.2) 938.9 (915.3) 124.9 ( 317.5; 567.3) 0.13 ( 0.33; 0.59) 0.693
Total activity 1119.2 (724.6) 1943.3 (1883.7) 1381.7 (763.4) 1944.3 (1370.3) 261.5 ( 381.8; 904.8) 0.17 ( 0.24; 0.57) 0.923

ES, Cohen’s effect size; 95% CI, 95% confidence interval. Insufficient patients for vigorous activity (n = 2 in the intervention group and n = 5 in the control group).
a
Equal to D(3months–baseline) in the intervention group minus D(3months–baseline) in the control group; D(3months–baseline) equal to the assessment at 3 months
minus baseline.
b
P-value from the generalized linear mixed model considering 3 months value as the dependent variable, group and baseline values as fixed effects, and spa centre and
period as random effects.

Table 3
Evolution of the WOMAC function, pain, Hospital Anxiety and Depression (HAD), Arthritis Self-Efficacy Scale (ASES), Knee Osteoarthritis Fears and Beliefs Questionnaire
(KOFBeQ) and Evaluation of the Perception of Physical Activity (EPPA) scores from baseline to 3 months and difference between intervention and control groups.

Intervention group Control group (n = 54)

(n = 52)

Baseline 3 months Baseline 3 months D(3months–baseline) between groups a Between groups

at 3 months
b
mean (SD) mean (SD) mean (SD) mean (SD) Absolute difference ES (95% CI) P-value
(95% CI)

WOMAC function 30.6 (16.8) 25.3 (14.6) 36.8 (18.0) 33.8 (17.3) 2.29 ( 8.85; 4.26) 0.16 ( 0.61; 0.29) 0.098
Pain
During last 24 hr 4.9 (2.1) 3.8 (2.6) 4.9 (1.9) 4.0 (2.0) 0.18 ( 1.11; 0.75) 0.08 ( 0.47; 0.32) 0.660
Most intense during last month 6.6 (2.5) 4.9 (2.8) 6.1 (2.0) 5.4 (2.6) 1.00 ( 2.09; 0.09) 0.38 ( 0.78; 0.03) 0.127
HAD
Anxiety 8.5 (3.4) 7.3 (3.5) 8.5 (3.6) 9.0 (3.6) 1.61 ( 2.58; 0.64) 0.65 ( 1.04; 0.25) 0.001
Depression 5.8 (3.0) 4.9 (3.6) 5.8 (3.0) 5.9 (3.2) 0.99 ( 2.06; 0.07) 0.36 ( 0.75; 0.03) 0.049
ASES
Pain 6.0 (2.0) 6.5 (1.7) 6.1 (2.0) 6.0 (1.8) 0.57 ( 0.14; 1.28) 0.31 ( 0.07; 0.70) 0.062
Function 7.5 (1.9) 7.7 (1.9) 7.2 (1.8) 7.6 (1.7) 0.25 ( 0.82; 0.33) 0.17 ( 0.55; 0.22) 0.600
Other symptoms 6.9 (1.8) 7.2 (1.8) 7.1 (1.8) 6.9 (1.9) 0.48( 0.10; 1.06) 0.32 ( 0.06; 0.71) 0.122
KOFBeQ
Daily living activities 10.6 (7.5) 8.9 (7.6) 11.2 (6.8) 9.7 (7.0) 0.22 ( 3.46; 3.01) 0.02 ( 0.42; 0.37) 0.861
Physician 22.5 (8.9) 19.4 (8.9) 18.4 (10.0) 19.8 (10.4) 4.57 ( 8.77 ; 0.38) 0.47 ( 0.87; 0.07) 0.171
Disease 7.7 (5.0) 7.3 (5.1) 6.4 (5.5) 7.2 (4.7) 1.13 ( 3.77; 1.52) 0.21 ( 0.59; 0.18) 0.928
Sports 8.2 (6.1) 7.7 (5.3) 8.6 (5.4) 8.3 (5.0) 0.26 ( 2.80; 2.28) 0.04 ( 0.43; 0.35) 0.607
Total score 49.0 (20.0) 43.3 (21.2) 44.5 (21.4) 45.0 (21.7) 6.18 ( 16.0; 3.64) 0.26 ( 0.66; 0.15) 0.412
EPPA
Motivation 75.4 (19.7) 79.4 (16.6) 75.0 (20.6) 71.6 (21.5) 7.43 ( 0.10; 14.97) 0.40 ( 0.01; 0.80) 0.019
Facilitators 77.3 (13.7) 78.3 (13.1) 78.1 (14.5) 76.3 (14.7) 2.76 ( 2.92; 8.43) 0.20 ( 0.21; 0.61) 0.333
Barriers 68.2 (18.7) 72.4 (16.2) 67.1 (18.5) 62.1 (20.4) 9.22 (2.16; 16.28) 0.54 (0.12; 0.95) 0.002
Beliefs 55.7 (23.3) 65.2 (23.2) 62.6 (20.5) 62.6 (20.8) 9.47 ( 0.30; 19.24) 0.40 ( 0.01; 0.81) 0.189

ES: Cohen’s effect size; 95% CI: 95% confidence interval.

a
Equal to D(3months-baseline) in the intervention group minus D(3months-baseline) in the control group; D(3months–baseline) equal to the assessment at 3 months
minus baseline.
b
P-value from the generalized linear mixed model considering 3 months value as the dependent variable, group and baseline values as fixed effects, and spa centre and
period as random effects.

significantly differ between the intervention and control groups
(P = 0.117).
4. Discussion
This study demonstrated that a self-management exercise
program had no significant complementary effect on improvement
in PA level in participants with KOA as compared with spa therapy
alone. A 3-week spa-therapy treatment may help increase the PA
level of people with KOA. The benefits of a self-management
education program were a significant improvement in perception of
PA, motivation and barriers subscales (EPPA) and anxiety and
depression (HAD) at 3 months after treatment. The self-management
exercise program offered a complementary therapy to the spa
therapy and alleviated pain and improved physical function and self-
efficacy but without statistically significant differences. To our
knowledge, this quasi-randomized trial is the first to assess the effect
of spa therapy on PA level and to compare the effect of a self-
management exercise program associated with spa therapy versus
spa therapy alone. This non-invasive, adapted, tailored and original
character of this intervention is a novel approach for knee OA
management.
4.1. Interpretation
The improvement in PA practice after spa therapy treatment
might be due to reduced symptoms but also a healthy and
 C. Gay et al. / Annals of Physical and Rehabilitation Medicine 63 (2020) 181–188
motivational environment [33]. Indeed, results were not signifi-
cant between groups, but improvement was greater in the
intervention than control group, particularly in terms of the
increase in PA level according to IPAQ and WHO guidelines. Also,
the relative risk of death from all causes depending on PA and
leisure-time sitting decreased by one class between baseline and
3 months, according to Patel et al. [34].
According to Forestier et al., spa therapy can alleviate pain
(mean 0.55 [range 0.35 to 0.75]) and reduce disability (mean
0.43 [range 0.22 to 0.64]) for people with KOA, with a medium
effect size [16]. Our results confirm the impact of spa therapy on
pain and disability for people with KOA.
PA practice is one of the key elements in the management of
knee OA symptoms according to international practice guidelines
[3]. However, many obstacles to exercises have been described
[35], such as fears and beliefs about pain, treatment and PA
[36]. For OA, pain, disability, comorbidities such as overweight or
obesity, fears and beliefs are factors that explain the decreased
mobility; they are interlinked with each other. These mechanisms
seem to be additive and contribute to reduce the mobility and
maintain the link between obesity and reduced mobility
[37]. Hence, changing the behavior of people with KOA is difficult
in terms of PA practice [38].
Education and self-management are based on the biopsycho-
social model of effective strategies for reducing fears and beliefs
and increasing adherence to treatment [39]. To our knowledge, this
study is the first to assess the effects of self-management education
associated with spa therapy on behavioral, cognitive and
psychological indicators in KOA management, with a limited
effect. The results also show for the first time that spa treatment
associated with an information booklet on physical activity may
help increase PA level for people with KOA.
The adherence to booklet exercises was significantly greater in the
intervention than control group. These results give information about
the qualitative improvement in PA practice in the intervention group.
The self-management exercise program improved the percep-
tion of PA and anxiety and depression, with small to medium effect
sizes in the intervention group. These findings were due to the
group effect program and may be due to the advice given by
medical staff [40,41]. The educational elements, specific exercises
and feedback were personalized and adapted to each patient
phenotype; the interest is to initially deal with cognitive and
psychological factors, then behavioral or biological factors [40].
4.2. Limitations
The number of self-management education exercise sessions in
this study may have been insufficient as compared with other
randomized controlled trials of exercises for OA [13]. A medium
effect size of spa therapy on PA level implies that obtaining an
intergroup effect size is difficult [42]. The lack of power was
another potential limitation. The number of participants required
was 71 per group to account for lost to follow-up. We included
enough people but not enough for final analyses because some
people with a high IPAQ category were included at baseline
evaluation and finally excluded from the analyses. We had missing
data because of the vagueness of the declarative assessment of PA
level by the IPAQ. Using a connected device tool to assess PA level
would have been relevant but could not be funded. Another
limitation concerns the lack of real blinding for participants and
caregivers of the study, which is quite impossible for this kind of
non-pharmacological study, although the assessors were blinded.
Despite the use of a cluster time-period randomisation with a
wash-out period, contamination bias cannot be excluded, although
measuring this bias in this kind of study is difficult. Because people
who attend a spa therapy are volunteers and could have a specific
187
motivation, we cannot exclude a selection bias for people included
in this study.
4.3. Generalisability
These results will likely help professional healthcare workers in
KOA management. Treatments should be based on modifiable risk
factors such as pain, function, obesity, comorbidities, intrinsic
barriers to PA practice, and sedentary time. The KOA population
seems more affected by these risk factors, and the most severely
affected patients are the less active. The key challenge for OA
treatment consists of increasing PA level to decrease risk factors.
This study showed the impact of 18 days of spa therapy on PA
level and confirmed the impact on pain and disability. It argues in
favor of the cognitive and psychological effect of a self-manage-
ment exercise program. Treatment strategies for KOA are limited,
and spa therapy associated with a self-management education
program is well tolerated and effective for KOA. This program could
be proposed as an additional therapeutic strategy for KOA patients.
Trial registration. The study protocol was approved by the
medical ethics committee of Sud-Est 6 (no. 2015/CE38) and was
registered at ClinicalTrials.gov (NCT02598804) on November 5,
2015.
Protocol. The protocol was published in BMC Complementary
and Alternative Medicine: Gay C, Guiguet-Auclair C, Pereira B,
Goldstein A, Bareyre L, Coste N, Coudeyre E. Efficacy of self-
management exercise program with spa therapy for behavioral
management of knee osteoarthritis: research protocol for a quasi-
randomized controlled trial (GEET one). BMC Complement Altern
Med. 2018 Oct 16;18(1):279. doi: 10.1186/s12906-018-2339-x.
CONSORT NPT Statement. The results are reported in accor-
dance with the CONSORT Statement for non-pharmacologic trials
(e-component).
Funding
This work was financially supported by the ‘‘Innovatherm cluster’’ and
‘‘Clermont-Ferrand Communauté’’. The ‘‘Auvergne region’’ for the ‘‘Cluster
network research grant’’ allowed us to recruit a PhD student to carry out this
study.
Author contributions
CG, EC, NC: conceived the study, designed the study protocol and drafted
the manuscript. CG and BP: designed the statistical analysis. NB, LG:
contributed to the writing of the protocol and read and approved the final
protocol.
Disclosure of interest
The authors declare that they have no competing interest.
Acknowledgments
The authors thank Nicolas Andant, Christine Levyckyj, Christine
Flouzat, Anne-Cécile Fournier and Anna Goldstein for help in study
management; Jean-Baptiste Lechauve, Elise Guilley and Anne Plan-
Paquet for contributing to the design of the intervention; and
patients and employees of the Thermal SPA Center.
Appendix A. Supplementary data
Supplementary data associated with this article can be found, in
the online version, at https://doi.org/10.1016/j.plantsci.2004.08.011.
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