Predictors of compliance with a home-based exercise program added

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Osteoporos Int (2005) 16: 325–331
DOI 10.1007/s00198-004-1697-z
O R I GI N A L A R T IC L E
Predictors of compliance with a home-based exercise program added
to usual medical care in preventing postmenopausal osteoporosis:
an 18-month prospective study
M.A. Mayoux-Benhamou Æ C. Roux Æ A. Perraud
J. Fermanian Æ H. Rahali-Kachlouf Æ M. Revel
Received: 1 December 2003 / Accepted: 15 June 2004 / Published online: 29 July 2004
International Osteoporosis Foundation and National Osteoporosis Foundation 2004
Abstract This prospective 18-month study was designed
to assess long-term compliance with a program of
exercise aimed to prevent osteoporosis after an educational intervention and to uncover determinants of
compliance. A total of 135 postmenopausal women were
recruited by flyers or instructed by their physicians to
participate in an educational session added to usual
medical care. After a baseline visit and dual-energy Xray absorptiometry, volunteers participated in a 1-day
educational session consisting of a lecture and discussion
on guidelines for appropriate physical activity and
training in a home-based exercise program taught by a
physical therapist. Scheduled follow-up visits were 1, 6,
and 18 months after the educational session. Compliance with the exercise program was defined as an exercise practice rate 50% or greater than the prescribed
M.A. Mayoux-Benhamou Æ H. Rahali-Kachlouf Æ M. Revel
Rehabilitation Department, Cochin Hospital,
Assistance Publique-Hôpitaux de Paris,
René Descartes University,
F-75014 Paris Cedex, France
C. Roux
Rheumatology Department, Hôpital Cochin,
Assistance Publique-Hôpitaux de Paris,
René Descartes University,
F-75014 Paris Cedex, France
A. Perraud
National School of Statistics and Economic Administration
(ENSAE), F-92245 Malakoff Cedex, France
J. Fermanian
Statistics Laboratory, Necker Hospital,
Assistance Publique-Hôpitaux de Paris,
René Descartes University,
F-75015 Paris Cedex, France
M.A. Mayoux-Benhamou (&)
Service de Rééducation, Hôpital Cochin,
27 rue du Faubourg Saint Jacques, Pavillon Hardy,
F-75014 Paris, France
E-mail: anne.mayoux-benhamou@cch.ap-hop-paris.fr
Tel.: +33-1-58412543
Fax: +33-1-58412545
training. The 18-month compliance rate was 17.8% (24/
135). The main reason for withdrawal from the program
was lack of motivation. Two variables predicted compliance: contraindication for hormone replacement
therapy (odds ratio [OR] = 0.13; 95% confidence
interval [95% CI], 0.04 to 0.46) and general physical
function scores from an SF-36 questionnaire (OR=1.26;
95% CI, 1.03 to 1.5). To a lesser extent, osteoporosis
risk, defined as a femoral T-score £)2.5, predicted
compliance (OR=0.34; 95% CI, 0.10 to 1.16). Despite
the addition of an educational session to usual medical
care to inform participants about the benefits of exercise,
only a minority of postmenopausal women adhered to a
home-based exercise program after 18 months.
Keywords Compliance Æ Determinants Æ Education Æ
Exercise Æ Osteoporosis Æ Quality of life
Introduction
Osteoporosis is an increasing health care concern
worldwide with the aging of the population [1]. This
disease is multifactorial, and the dominant factor
affecting bone metabolism in postmenopausal women is
the decline in estrogen secretion. Other factors such as
decreased physical activity [2] have been identified.
Besides pharmacological interventions such as hormone
replacement therapy (HRT), physical activity [3] is
commonly recommended for preventing osteoporosis
and may be synergistic with estrogen level [4]. Therefore,
prophylactic and therapeutic regimens may also include
nonpharmacological interventions such as patient education to promote the long-term adoption of adequate
lifestyle changes in postmenopausal women. However,
these interventions are rarely used [5, 6, 7, 8]. Unfortunately, in osteoporosis, as in other chronic diseases,
long-term compliance is poor [9]. An extensive search of
Medline for osteoporosis exercise therapy revealed
326
studies of long-term exercise compliance in clinical trials
[10, 11, 12, 13, 14, 15] but none on exercise compliance
in postmenopausal women in usual medical care or
identification of its predictors.
The aim of this prospective study was to assess
compliance with long-term, home-based exercise and to
identify the predictive factors of compliance in postmenopausal women 18 months after a 1-day educational
intervention was added to usual medical care.
nized into groups of 12 for the session, which included a
lecture and a discussion. The lecture provided knowledge
about osteoporosis symptoms, management, and appropriate preventive lifestyle behaviors. It focused especially
on guidelines for practicing adequate physical activity.
The discussion aimed to enhance positive attitudes and
beliefs related to exercise. Then the participants were split
into groups of four to learn the exercise program.
Home-based exercise program
Methods
Subjects
The Rehabilitation Department of the Institute of
Rheumatology at Cochin Hospital in Paris has advocated an educational session addressing exercise in preventing osteoporosis in postmenopausal women since
1994. Outpatients of the institute were either informed
by flyers or instructed by their physicians to participate
in this educational session. Recruitment lasted from
March 1999 to March 2000.
To participate in the study, women had to be 70 years
of age or younger, to have ceased the menses for at least
1 year, and had the physical ability for the selected
training. Patients were excluded if they had a clinical
history of a vertebral fracture or any previous general
health conditions such as rheumatoid arthritis or respiratory failure that made health recommendations inappropriate.
Baseline evaluation
The women had a baseline medical visit and underwent
dual-energy X-ray absorptiometry (DXA).
At the medical visit, data were collected on previous
medical history, risk factors of osteoporosis, and lifestyle
behaviors. Each woman completed an SF-36 questionnaire [16] and a Baecke questionnaire [17]. The SF-36
questionnaire assesses quality of life and measures health
across three dimensions (functional status, well-being,
and overall evaluation of health) with eight domains (such
as physical functioning, vitality, social functioning, or
mental health). One additional item measures health
transition. The Baecke questionnaire assesses usual
physical activity and measures habitual occupational and
leisure-time (sport and nonsport) physical activity. Both
questionnaires are validated in French [18, 19]. Lumbar
and femoral DXA (Hologic QDR 1000; Hologic, Waltham, MA, USA) was performed on the same day, and
T-scores were calculated. Results were given raw, without
comments, to the participants.
Educational session
The 1-day educational session occurred within the
2 weeks after the baseline visit. Participants were orga-
The daily exercise program included four exercises to
reinforce hip flexor (especially iliopsoas), hip abductor
(especially gluteus medius), erector spinae, and pronator
muscles. The exercises, except those for erector spinae
muscles, were performed with use of dumbbells and were
divided into sets of 10 submaximal repetitions. The
program included 30 repetitions of spine extension, 50
repetitions of flexion of each hip, 30 abductions of each
hip, and 50 eccentric pronator contractions on each side.
The program could be performed in one session or split
into short sessions throughout the day. A physical
therapist taught the exercises and checked that they were
correctly performed. The participants also received a
booklet to review the exercises.
Follow-up visits
Over the long term the women had to practice the
exercise program daily and visit their physician 1, 6, and
18 months after the educational session. At each followup visit, correct exercise accomplishment was checked
and exercise compliance assessed as described below.
The times for the 1- and 6-month visits were calculated
from the day of the educational session. At the
18-month evaluation, participants were requested to
indicate the physical activities they initiated after the
educational session and to complete again the Baecke
and SF-36 questionnaires. Participants who missed the
18-month follow-up visit were telephoned and asked to
complete mailed questionnaires.
Assessment of exercise compliance
The compliance rate was measured according to the
method used in previous studies [13, 20]. For each
exercise, weekly practice was calculated as the proportion between the self-reported mean number and the
prescribed number of exercise repetitions in a week. To
be compliant during the study, each participant had to
(1) have practiced at least three of the four exercises,
and, for each exercise, to have performed weekly at least
50% of the prescribed repetitions; and (2) have disrupted training less than 1 month before the 6-month
follow-up visit and less than 3 months before the
18-month follow-up visit.
327
Statistical methods
Qualitative variables were described with proportions
and percentages. Proportions were compared with use of
the v-square test. Quantitative variables were described
with means and standard deviations (SD). The means of
two independent groups were compared with use of
Student’s t-test. All statistical tests were 2-tailed, with
significance set at p<0.05.
A logistic regression analysis was performed to
identify the variables predicting exercise compliance.
Following Hosmer and Lemeshow’s recommendations
[21], the analysis was performed in two steps. First,
explanatory variables were selected after taking into
account both their clinical relevance and the level of
significance in the univariate comparisons (p<0.05) of
compliant and noncompliant subjects. Despite their lack
of significance, some variables were included because of
findings from previous studies [7, 22]. The studied predictor variables were (1) the method of recruitment
(1 = informed by flyers and self-registered, 2 = instructed by physician to participate); (2) the level of
education (1 = highly educated women who had studied in a university or equivalent, 2 = others); (3) current
occupational status (1 = currently employed, 2 = retired, housewife, etc.); (4) family history of osteoporosis
as suggested by participant’s beliefs (1 = yes, 2 = no);
(5) personal history of postmenopausal low-impact
fractures (1 = yes, 2 = no); (6) lumbar T-score £)2.5
(1 = yes, 2 = no); (7) femoral neck T-score £)2.5
(1 = yes, 2 = no); (8) contraindication for hormone
replacement therapy (HRT) (1 = yes, 2 = no); (9)
score on the Baecke questionnaire assessing usual
physical activity; (10) physical functioning; (11) vitality;
and (12) mental health. The three last variables are
domain scores from the SF-36 questionnaire.
Second, the fit of several logistic regression models
was compared after eliminating in a stepwise manner
one or more possible predictors. The fit of each model
was assessed by use of the concordant results of four
tests of goodness of fit. The outliers in the solution obtained were checked by examinating residuals. Only the
results of the best model are given here. The statistical
software used was SAS version 8.
Table 1 Characteristics of participants (n=135).HRT Hormonal
replacement therapy
Variables
Mean ± SD
Age, years
Menopausal age, years
Weight, kg
Height, cm
Fat, %
Femoral neck T-score
Lumbar T-score
University or college educated
Informed by flyers
Family history of osteoporosis
Low-trauma fractures
Femur T-score £)2.5
Lumbar T-score £)2.5
Use of HRT
Contraindication to HRT
Use of bisphosphonate therapy
Use of calcium supplements
59.6±6.2
48.98±5.3
59.14±10.44
159.5±5.94
36.47±7.15
–2.28±1.21
–2.35±1.23
Number
45
101
49
27
40
71
62
29
28
44
%
33
75
36
20
30
53
45.9
21.5
20.7
32.6
appendicular skeletal sites). The mean lumbar T-score
was )2.35 (SD=1.23) and the mean femoral neck
T-score )2.28 (SD=1.21). The lumbar T-score was
£)2.5 in 53% (71/135) of patients and the femoral neck
T-score £)2.5 in 30% (40/135).
Among the 73 patients not using HRT, 40% (29/73)
had a medical contraindication (15 breast tumor, 2
endometrial cancer, 3 endometriosis, 5 thrombosis, 1
meningioma, 2 lupus, 1 otospongiosis), and 15 were
treated with bisphosphonates.
Compliance results
Compliance rates
The 18-month exercise compliance rate was 17.8% (24/
135) (39.3% [53/135] at 1-month and 28.1% [38/135] at
6-month follow-up), even though 84.4% (114/135)
bought dumbbells requested for the exercise program.
Reasons for withdrawal were lack of motivation (61%;
84/135), unrelated events (16%; 22/135), or pain related
to the assigned training (4%; 6/135). No specific exercise
was responsible for the lack of motivation (Table 2).
Results
For characteristics of the study patients see Table 1. Of
the 142 women included at the baseline visit, 7 were not
included in the final assessment because they had health
problems (1 myasthenia gravis and 3 cancer) or personal
events upsetting their lives (3 patients).
The
135
participants
averaged
59.6 years
(SD=6.2 years). Most (75%; 101/135) were informed by
flyers and self-registered, 36% (49/135) reported a family
history of osteoporosis, and 20% (27/135) had a personal history of postmenopausal low-impact fractures
(18 in the wrist, 8 in the ribs, 5 in the foot, 10 in other
Table 2 Home-based exercise compliance in postmenopausal women (n=135)
Exercise
Compliant women
1 month
Number
Pronator
Hip flexor
Hip abductor
Erector spinae
Full program
59
61
61
41
53
6 months
%
43.7
45.2
45.2
30.4
39.3
Number
37
40
45
30
38
18 months
%
27.4
29.6
33.3
22.2
28.1
Number
24
29
40
22
24
%
17.8
21.5
29.6
16.3
17.8
328
Pain was the main reason for withdrawal of the erector
exercise (7%; 10/135), and previous radial fracture or
thumb arthritis often prohibited the pronator exercise
(4%; 6/135).
Predictors of 18-month compliance
Univariate comparisons are shown in Table 3. The
exercise compliance level was significantly higher in
women with a contraindication for HRT (p<0.01). As
well, usual physical activity as assessed by the Baecke
questionnaire was associated with compliance (p<0.07).
No significant difference was found in compliant women
for the other explanatory variables.
Logistic regression
In the best model (Table 4), the predictors of 18-month
exercise compliance were contraindication for HRT
(odds ratio [OR] = 0.13; 95% confidence interval [95%
CI], 0.04 to 0.46) and general physical function score of
the SF-36 questionnaire (OR=1.26; 95% CI, 1.03 to
1.54). Moreover, a femoral T-score of £)2.5 tended to
predict 18-month compliance (OR=0.34; 95% CI, 0.10
to 1.16).
Changes in physical habits
At the 18-month visit, 18.5% (25/135) of the study
group, including 19 noncompliant women, were regularly practicing a physical activity initiated after the
educational session (15 were taking gymnastics classes,
including aquatic training; 3 jogging; 3 hiking; 2 biking;
and 2 swimming).
The 18-month level habitual leisure-time activity
measured by the Baecke subscores was higher than
baseline in nearly half of the participants. Thus, the
level of sport activity increased in 35.6% (48/135)
participants and the level of nonsport activity in 40%
Table 4 Predictors of 18-month exercise compliance in 135 postmenopausal women. Results of logistic regression analysis
Predictors
Odds
ratio
95% confidence
interval
Contraindication
for HRT
Physical functioning
(SF-36 score)
Femoral T-score £)2.5
Vitality (SF-36 score)
Recruited by flyers
University or colleg
educated
Currently employed
Family history of
osteoporosis
Fracture(s)
Level of physical activity
(Baecke score)
Mental health
(SF-36 score)
0.13
0.04
0.46
1.26
1.03
1.54
0.34
0.83
1.80
1.61
0.10
0.66
0.47
0.83
1.16
1.05
6.94
3.13
1.80
0.64
0.58
0.18
5.56
2.19
1.11
1.04
0.27
0.99
4.57
1.09
1.07
0.88
1.30
(54/135). Comparison of compliant and noncompliant
groups demonstrated a significant increment of the
leisure-time sport activity (mean = 1.93 [SD=1.64]
and mean = )1.06 [SD=4.04]; p=0.001, respectively)
and nonsport activity (mean = 0.58 [SD=1.67] and
mean = )0.89 [SD=3.53]; p=0.049, respectively).
Impact on quality of life
The global score of the SF-36 and its domains did not
change at 18-month follow-up. Only two domains and
one dimension changed differently in compliant and
noncompliant
groups:
vitality
(mean = 0.96
[SD=3.52] and mean = )0.38 [SD=3.33]; p=0.079,
respectively), general health (mean = 0.83 [SD=2.55]
and mean = )0.32 [SD=3.12]; p=0.092, respectively)
and functional status (mean = 0.36 [SD=1.23] and
mean = )0.03 [SD=0.95]; p=0.089, respectively).
Table 3 Univariate comparison of postmenopausal women compliant and not compliant with an 18-month exercise program. HRT
Hormonal replacement therapy
Explanatory variables
Recruited by flyers
University or college educated
Currently employed
Family history of osteoporosis
Fractures
Lumbar T-score £)2.5
Femoral T-score £)2.5
Contraindication for HRT
Age
Level of physical activity (Baecke score)
Physical functioning (SF-36 score)
Vitality (SF-36 score)
Mental health (SF-36 score)
Compliant (n=24, 17.8%)
Not compliant (n=111, 82.2%)
Number
%
Number
19
9
12
8
4
16
10
11
79
39
50
33
17
67
42
46
Mean ± SD
82
37
71
41
23
55
30
18
59.71±5.73
84.84±8.25
26.04±3.00
12.79±4.68
18.54±4.27
%
p Value
Mean ± SD
73.9
33.0
63.7
36.9
20.7
49.6
27.0
16.2
59.32±6.46
79.33±14.06
26.65±4.16
13.59±3.51
19.04±4.61
0.59
0.57
0.21
0.74
0.66
0.13
0.15
0.01
0.78
0.07
0.12
0.34
0.62
329
Discussion
Very little data are available on compliance with exercise
therapy in routine medical care. The aim of the present
study was to assess long-term self-reported compliance
with a home-based exercise program described in a
1-day educational session added to usual medical care in
France.
One of the most commonly recommended lifestyle
behaviors to prevent osteoporosis is adequate physical
exercise. Numerous studies have shown that regular
physical activity can increase bone density [12, 23] and
that the bone-preserving action of exercise in postmenopausal women [24] may contribute to the prevention of
osteoporotic fractures [3]. We selected the home-based
exercise program on the basis of its site-specific effect of
loading on bone remodeling [20, 25, 26]. Recommended
contractions were submaximal, since strength training is
supposed to be more osteogenic then endurance training
[27]. It has been previously demonstrated that the hipflexion exercise in our exercise program has a lumbar
bone–preserving effect, which is attainable in postmenopausal women [13, 20]. The impact of the home program on bone density was not assessed in this ‘‘real
world’’ setting because it was assumed that concurrent
pharmacological treatments for osteoporosis could
mask the proper effect of the exercise training on bone
remodeling.
Despite an expected baseline motivation to change
lifestyle behaviors in women mainly recruited via flyers,
who had a personal history of fracture and/or low bone
density as measured by DXA, long-term exercise compliance was poor, and the most common deterrent to
exercise was lack of motivation, as was seen in other
studies [28, 29]. Low levels of compliance to treatment
recommendations are found across various health states;
treatments [9], including HRT [30, 31, 32, 33, 34]; and
ages. However, it was noticeable that, in the present
study, at the 18-month visit, 18.5% (25/135) of the study
group, including 19 noncompliant women, were regularly practicing an aerobic physical activity initiated
after the educational session and that the level of leisuretime physical activity as assessed by the Baecke questionnaire increased in nearly 50% of participants.
The home-based exercise compliance level was lower
than that in published results from long-term prospective controlled trials in postmenopausal women
(see [11, 12] for review). Thus, the use of hip-flexion
exercise was higher in our previous study after 3-year
follow-up (42%) [13] than in the present study after 18month follow-up (21.5%), although it was the same
exercise and the same self-reported compliance assessment. In Hans and colleagues’ controlled study [14],
18-month compliance with an impact-loading program
with use of a home Osteocare device was more than
80%, and in Smith and colleagues’ study, exercise
compliance remained nearly 70% for as long as
48 months [10]. In controlled exercise trials, investiga-
tors are probably more concerned than physicians
about their routine, and patients are more engaged
after giving informed consent. Indeed, the importance
of attitudes in predicting intention to exercise and
exercise behaviors has recently been highlighted [35].
Moreover, repeated incentives and evaluations that do
not currently exist in usual medical practice might enhance participants’ motivation and compliance. Besides
the methodological and psychological factors related to
clinical controlled trials, the modalities of the training
could influence compliance: a home-based training is
less time-consuming, is inexpensive, and can be fit to
any lifestyle. But such training is certainly less attractive than a program that includes running and dancing
classes [10] and does not allow for the social interactions of group activities, which are thought to play an
important role [34]. However, compliant subjects tended to feel increased vitality, improved functional status, and a positive health change. In the present study,
the main reason for withdrawal was lack of motivation.
A very brief program with a biofeedback mechanism
such as that provided by the home Osteocare device
[14] might enhance compliance.
Therefore, there is a great need to identify factors
that influence compliance with a home-based exercise
program. In the present study, the strongest predictor of
exercise compliance at 18 months was a contraindication
for HRT. As suggested by den Tonkelaar and Oddens
[36], women might be less concerned about osteoporosis
once they are long-term HRT users. The opportunity for
pharmacological treatment may put postmenopausal
women’s minds at rest and decrease their motivation to
improve lifestyle behaviors.
Physical functioning, a domain of the SF-36 questionnaire that assesses limitations in performing all daily
activities, also predicted 18-month compliance. Thus, a
subjective perception of physical functioning and limitations was a predictor, even though the usual level of
physical activity was not. However, physically active
women are more likely to be compliant with long-term
exercise [37]. Unfortunately, it has been shown that
osteoporotic women with fractures have a low health
status and a low level of spontaneous physical activity
[38]. Few studies have assessed health-related measures
of quality of life as predictors of successful completion
of physical treatment [39] or as an outcome of physical
activity programs [15, 40, 41, 42] in musculoskeletal
disorders.
Low bone density in the femoral neck, indicated by
a T-score of £)2.5, tended to predict exercise compliance at 18 months (p=0.08). This score, which is the
threshold of osteoporosis [43], could induce fear related
to upper femur fracture and convince postmenopausal
women to adopt appropriate lifestyle changes, even
though other potentially upsetting risk factors such as
family history of osteoporosis or previous low-impact
fractures did not predict compliance. DXA has been
proposed as a screening test for osteoporosis to help
postmenopausal women use HRT, comply with HRT
330
[6, 33, 36, 44, 45, 46, 47], and comply with
health-related lifestyle behaviors, including physical
and dietary habits [7, 36, 44, 47]. But adverse DXA
results can also induce lifestyle behaviors such as limiting physical activities to prevent falling [44]. Appropriate advice could forestall these changes.
Regardless, in our study, exercise compliance at
18 months in postmenopausal women was low. Even
more intensive interventions are ineffective in promoting
1-year adherence to exercise to prevent cardiovascular
diseases [48]. Motivational strategies are needed to
convince participants to train physically over the long
term. Tailored advice and regular incentives from all
health care professionals [42] could be a first low-cost
step toward improving women’s awareness of the benefits of exercise besides pharmacological therapy after
menopause. Unfortunately, most physicians, though
aware of the health benefits of exercise, admit that they
rarely address the subject with their patients [49]. Tailored exercise training and regular incentives could offset
physical and psychological barriers to exercise. However, such considerations require convincing both health
care professionals and patients to become engaged in
exercise therapy.
Conclusion
An educational intervention, set in a unique session and
added to usual medical practice, convinced only a
minority of postmenopausal women to be compliant
after 18 months with a home-based exercise program to
prevent osteoporosis. Lack of a pharmacological alternative such as HRT contraindication or health factors
such as subjective perception of physical function and
limitations and, to a lesser extent, low bone density,
predicted compliance. Identification of psychological
profiles and physical health factors and tailored training
could be considered to overcome barriers to exercise.
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