Behavioural graded activity results in better exercise adherence. Introduction

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1 Chapter 5 Behavioural graded activity results in better exercise adherence than usual exercise treatment in patients with osteoarthritis: a randomised trial Published as: M.F. Pisters, C. Veenhof, F.G. Schellevis, D.H. de Bakker, J. Dekker. Behavioural graded activity results in better exercise adherence than usual exercise treatment in patients with osteoarthritis: a randomised trial. Journal of Physiotherapy, 2010; 56 (1):

2 Abstract Question - Does Behavioural Graded Activity result in better exercise adherence and a higher level of physical activity compared to usual exercise treatment in patients with osteoarthritis of hip or knee? Design - Secondary analyses were performed using the data of a cluster randomized clinical trial with concealed allocation and assessors blinded. The statistical analyses were carried out according to the intention-to-treat principle. Participants - Two hundred patients with hip and/or knee osteoarthritis. Intervention - Behavioural graded activity (experimental group) was compared with usual exercise treatment (control group) according the Dutch guideline for physiotherapy in patients with osteoarthritis of the hip or knee. Outcome measures - Exercise adherence and physical activity were measured with self-report questionnaires. Assessments were conducted at 13 and 65 weeks follow-up. Results - Short-term (OR=3.68 [1.81 to 7.48]) and long-term adherence (OR=2.82 [1.44 to 5.49]) to home exercises was significantly higher in the experimental group compared to control group. Furthermore, significantly more patients in the experimental group met the recommendations for the amount of moderate-vigorous intensity physical activity compared to patients in the control group, both after 13 (OR=4.55 [1.77 to 11.67]) and 65 weeks follow-up (OR=2.58 [1.18 to 5.63]). Conclusion - Behavioural graded activity results in better exercise adherence and a higher level of physical activity than usual exercise treatment in patients with osteoarthritis of the hip or knee, both in the short- and longterm. 104

3 Behavioural graded activity results in better exercise adherence Introduction Osteoarthritis of the hip and/or knee is a relatively common musculoskeletal disorder, with a high prevalence increasing with age. 1 Osteoarthritis causes impairments in body functions and/or structures such as pain, muscle strength, range of joint motion, and joint stability. Furthermore, osteoarthritis has a major impact on physical functioning in daily life and often leads to avoidance of physical activity. 2-5 A lack of regular physical activity in patients with osteoarthritis of the hip and/or knee is an important risk factor for further functional decline and is associated with increased health care costs. 6 In several treatment guidelines exercise is recommended in patients with osteoarthritis of the hip and/or knee The goal of exercise therapy is to reduce impairments in body functions and improve overall physical functioning, so that ultimately individuals can better meet the demands of daily living. 12 Physiotherapists choose the delivery mode, content, and dosage of exercises based on their clinical decision-making process. 13 Several studies have shown beneficial effects of exercise in patients with osteoarthritis of hip and/or knee on pain, physical function and patients self perceived effect Unfortunately, the positive post-treatment effects of exercise seem to decline over time and finally disappear in the long term. 17 Exercise adherence within the period of treatment has shown to be an important predictor of outcome of exercise. 18;19 Several authors have suggested that low adherence rates to home exercises after discharge is one of the main reasons for poor long-term effectiveness of exercise in patients with osteoarthritis For improvement of exercise adherence post-treatment, it is expected that exercises should become functional and task-oriented, including strategies to improve exercise behaviour and self-regulation skills. 20 It is expected that home exercises that simulate the conditions of daily tasks will enhance adherence to home exercises after discharge and will finally lead to a more physically active lifestyle. Veenhof et al. recently developed and evaluated an exercise program based on these principles called the behavioural graded activity program. 21 The 105

4 Chapter 5 behavioural graded activity program consists of a facility based treatment period followed by additional booster sessions. This form of exercise therapy uses operant behavioural principles 22;23, self-regulation principles 24 and booster sessions, in order to improve and maintain adherence. 25 The behavioural graded activity program is directed at enhancing exercise adherence and gradually increasing the level of physical activities in a time contingent way. The ultimate goal is integration of these activities into patients daily living, so that patients get a more physically active lifestyle. Earlier research has shown that both behavioural graded activity and usual exercise treatment by physiotherapists according the Dutch guideline 10 result in positive effects on pain and physical functioning. 21 Significant differences in long-term effectiveness in favour of behavioural graded activity were found in physical functioning, measured with the MACTAR-questionnaire and 5 meter walking test. Although the effectiveness of behavioural graded activity on pain and physical function is investigated it is unclear if behavioural graded activity succeeds in increasing adherence and physical activity. Therefore, the research questions for the present study were: 1. Does behavioural graded activity result in better exercise adherence than usual exercise treatment in patients with osteoarthritis of hip and/or knee? 2. Does behavioural graded activity result in a higher level of physical activity than usual exercise treatment in patients with osteoarthritis of hip and/or knee? Method Design Secondary analyses were performed using the data of the Behavioural Graded Activity trial, in which the effectiveness on pain, physical function and patients global assessment of two exercise interventions was compared 21 ; an operant behavioural graded activity program (experimental group) and usual physiotherapy care according to the Dutch physiotherapy guideline (control group). To avoid contamination of interventions, cluster randomization was performed at the level of the participating physiotherapy practices. The participating practices were randomly assigned to one of the two treatment 106

5 Behavioural graded activity results in better exercise adherence groups by means of a computer generated random sequence table. Patients were allocated to a physiotherapist by choosing a physiotherapist from a list of participating physiotherapists. At the time that patients chose a physiotherapist from the list of participating physiotherapist, the patients were not aware of the kind of intervention the physiotherapists were assigned to. Assessments were conducted at 0, 13, and 65 weeks and performed on a test location. Three trained research assistants, who were blinded for the assigned treatment, performed all assessments. Patients were instructed not to give information about the allocated treatment to the research assistants. The study was approved by the Medical Ethical Committee of the VU University Medical Center, Amsterdam, The Netherlands. Participants Physiotherapist working in primary care in the region of Utrecht were eligible for inclusion. A random sample of six hundred physiotherapists from the region of Utrecht was drawn from our Institute s National Database of Primary Care Physiotherapists and was invited to participate in the study. This sample was representative for all primary care physiotherapists in the Netherlands. One hundred physiotherapists responded of whom 87 (working in 72 practices) were willing and able to participate. Patients with osteoarthritis of the hip or knee were recruited in two ways. First, patients referred to physiotherapy were recruited by the participating physiotherapist at their first visit (November 2001-May 2003). Because the recruitment rate was rather slow, a second recruitment strategy was introduced, i.e. patients responded to articles about exercise and the performed study, published in local newspapers (November 2002-May 2003). A description of the recruitment strategies has been published elsewhere. 26 Inclusion criteria were osteoarthritis of hip or knee according to the clinical criteria of the American College of Rheumatology. 27;28 Exclusion criteria were: other pathology explaining the complaints; complaints in less than 10 out of 30 days; treatment for these complaints with exercise therapy in the preceding six months; under 50 or over 80 years of age; indication for hip or knee replacement within one year; contraindication for exercise; inability to understand the Dutch language; and a high level of physical functioning, 107

6 Chapter 5 because patients who perform at a high level of physical functioning at baseline do not need to increase their level of physical functioning. A high level of physical functioning was operationalized on a score of less than two on the sections walking ability and physical function of the Algofunctional index. 29;30 The same inclusion procedure was performed for all patients. First, they received oral information by phone, after which a first screening was performed. If patients were eligible, written information was sent and a final screening visit at home was planned (to check the ACR- and exclusion criteria) and, if patients were willing and eligible, informed consent was signed. Furthermore, demographic and clinical data were collected for each patient including age, gender, height, weight, location of complaints, duration of complaints and the presence of other chronic disorders. X-rays of the hip and/or knee were scored by a rheumatologist following a standardized procedure according to the Kellgren and Lawrence scale; consisting of five degrees: 0. no osteoarthritis, 1. doubtful osteoarthritis, 2. minimal osteoarthritis, 3. moderate osteoarthritis and, 4. severe osteoarthritis. 31;32 Pain and physical functioning were measured with the WOMAC. 33 Intervention The experimental group received a behavioural exercise treatment (called behavioural graded activity), in which concepts of operant conditioning and booster sessions were integrated. Behavioural graded activity was based on the time-contingency-management as described by Fordyce 22 and applied by Lindström. 23 Time-contingency-management means that exercises or activities are gradually increased by preset quotas (ie, the patients did not stop the exercise because of pain or other tolerance factors), based on systematically performed baseline measurements. An example of timecontingent-management is increasing the amount of walking time by 2 min per day, despite the amount of pain. The intervention is directed at increasing the level of activities in a time-contingent way, with the goal to integrate these activities in the daily living of the patients. Furthermore, the intervention included individually tailored exercises to improve impairments limiting the performance of these activities. Appendix 5.1 presents a 108

7 Behavioural graded activity results in better exercise adherence description of the concept and content of the experimental intervention as applied in our study. The experimental treatment was outlined in a complete protocol and included written materials (e.g. education messages, activity diaries, performance charts). The treatment consisted of a 12-week period with a maximum of 18 sessions, followed by five pre-set booster moments with a maximum of seven sessions (respectively in week 18, 25, 34, 42, and 55; in week 18 and 25 it was allowed that patient received 2 sessions if necessary). The physiotherapists in the control group were requested to treat the patients according to the Dutch physiotherapy guideline for patients with hip and/or knee osteoarthritis. 10 This guideline consists of general recommendations, emphasizing provision of information and advice, exercise, and encouragement of a positive coping with the complaints (see appendix 5.2). The treatment consisted of a maximum of 18 sessions within a period of 12 weeks. The treatment could be discontinued within the 12-week period if, according to the physiotherapist, all treatment goals had been achieved. At the end of the 12-week treatment period physiotherapist advised patients to maintain exercising at home. Both the experimental and control interventions were given individually by physiotherapists in primary care. One session in primary care lasted approximately 30 minutes. Physiotherapists in both groups received training on the allocated treatment and the physiotherapists in the experimental group were supported and advised by phone and meetings during the study. Physiotherapists in the experimental group received a 2 days-training, which focused on specific skills, necessary to perform a behavioural exercise treatment like behavioural graded activity. The physiotherapists in the control group received a 4 hour-training concerning the Dutch guideline. All physiotherapists documented every session on standardized registration forms, including information about deviations from the protocol. Contrast between the experimental and control group There are several important differences between the experimental and control group. In the experimental treatment exercises directed at improving impairments in body functions (e.g. muscle strength, range of joint motion, 109

8 Chapter 5 and joint stability) and patients most problematic activities were gradually increased using pre-set quotas (time-contingent management), based on systematically performed baseline measurements. The frequency and intensity of exercises in the control intervention depended on tolerance factors, such as pain (pain-contingency-management). In the control group patients only got a general advice to be more physically active (e.g. patients are instructed to walk more often). In contrast with the control intervention, specific behavioural interventions are used in the experimental group, including a performance chart, specific goal-setting, systematic reinforcement of exercise behaviour and extinction of pain behaviour (see appendix 5.1). Furthermore, after the 12 weeks treatment period, only patients in the experimental group received additional booster sessions: in these sessions, the progress made by the patient was evaluated, the principles of behavioural graded activity were repeated, and patients were encouraged to adherence to the recommended exercises and activities. Outcome measures Exercise adherence Exercise adherence was defined as the extent to which a person s behaviour doing home exercises or activities corresponds with agreed recommendations from their physiotherapist. 34 Home exercises are exercises directed at improving impairments in body functions, such as muscle strength, range of joint motion, and joint stability. Home activities refers to the actual performance of recommended activities by a physiotherapist, such as walking, walking stairs, and cycling. Adherence was measured with a selfreport questionnaire. Patients were asked whether their physiotherapist advised them to do home exercises (e.g. muscle strengthening exercises) or home activities (e.g. walking or cycling). When home exercises or activities were advised, patients were asked whether they performed the instructed home exercises or activities as recommended by their physiotherapist, assessed on a 5-point scale (1 = almost never; 5 = very often). 35 Patients were asked separately about their adherence to the instructed home exercises and home activities as recommended by their physiotherapist. 110

9 Behavioural graded activity results in better exercise adherence Physical activity The level of physical activity was assessed by the SQUASH (Short Questionnaire to Assess Health Enhancing Physical Activity). 36 The SQUASH consists of three main queries, namely days per week, average time per day, and self reported intensity. The amount of physical activity was measured for commuting activities, leisure time and sport activities, household activities, and activities at work or school. Using the Ainsworth Compendium of Physical Activities 37, an intensity score (metabolic equivalents) was assigned to all physical activities. The SQUASH questionnaire measures the habitual physical activity level and allows calculating whether patients meet the updated recommendations for physical activity from the American College of Sports Medicine and the American Heart Association. 38 The primary recommendation for the amount of physical activity is defined as moderateintensity and aerobic physical activity for a minimum of 30 minutes on at least five days a week or vigorous-intensity aerobic physical activity for a minimum of 20 minutes on at least three days each week. Combinations of moderate- and vigorous-intensity activities can also be performed to meet this recommendation (at least 450 MET. min. wk). For older adults moderateintensity was defined as activities with a intensity of 3 5 MET and vigorous-intensity was defined as activities with a intensity of 5 MET. 39 Data analysis The target sample size was 200 patients. This number yields to a power of 80% to detect a 25% difference in patient global assessment (PGA) and small to medium-sized effects (effect-size= ) in the outcome measures pain and physical functioning, at two-sided significance level of 0.05 given a maximum loss to follow-up of 20%. 40 Descriptive statistics were used to describe the main characteristics of the study population and to explore baseline comparability. The statistical analyses were carried out according to the intention-to-treat principle. The ratings on exercise adherence were dichotomized as adherence (often adherent and very often adherent) versus non-adherence (regularly adherent, occasionally adherent, almost never adherent). Odds ratios with their 95% confidence intervals were calculated to test differences between groups. The amount of physical activity was estimated by calculating whether patients met the updated recommendation for the amount of physical activity. Furthermore, change scores (by 111

10 Chapter 5 subtracting the baseline scores from the post-treatment scores) for days per week with minimal 30 minutes of moderate- or vigorous-intensity physical activity were calculated. Multiple (logistic or linear) regression analyses were performed with exercise adherence (adherence or non-adherence), physical activity (meeting or non-meeting the recommendation for physical activity), or change scores of days per week moderate- or vigorous-intensity physical activity as the dependent variable and type of intervention (experimental versus control group) as the independent variable. Confounding effects and effect modification of the baseline scores of each outcome measure, duration of symptoms, location of osteoarthritis (hip, knee, or both), radiological evidence, body mass index, co morbidity, age, sex, and recruitment method (physiotherapist or newspaper) were investigated. In case of confounding effects of these characteristics, they were used as covariates in the adjusted analyses. P values less than 0.05 were considered statistically significant. All analyses were performed using SPSS

11 Behavioural graded activity results in better exercise adherence Figure 5.1: Design and flow of participants through the trial 113

12 Chapter 5 Results Flow of participants, therapists, centres through the trial A total of 200 patients were included in the trial: 97 patients in the experimental group and 103 patients in the control group. The experimental and control group had similar baseline characteristics and baseline values of outcome measures, as presented in table 5.1. Assessment at week 13 was completed by 90 patients (93%) in the experimental group and 102 patients (99%) in the control group, and 87 patients (90%) in the experimental group and 92 patients (89%) in the control group completed the trial up to 65 weeks (see figure 5.1). Fifty-five physiotherapists treated the patients included in this study. The characteristics of therapists and centres are presented in table 5.2. Compliance with trial method Overall, thirty-three patients (17%) deviated from the study protocol. Ten patients (10%) in the control group deviated from the study protocol, because treatment was terminated within 6 sessions. In the experimental group 23 patients (24%) deviated from the protocol, namely in 6 patients (6%) the treatment was terminated within 6 sessions and in 17 patients (18%) less than 2 booster sessions were performed. The patients who were allocated to the experimental group received on average 9.8 (sd 3.5) treatment sessions (excluding the booster sessions) versus 11.7 (sd 4.3) in the control group (mean difference: -1.9 [-3.0; -0.8]). Patients in the experimental group received on average 4.8 (sd 1.6) additional booster sessions. 114

13 Behavioural graded activity results in better exercise adherence Table 5.1: Baseline characteristics of participants. Characteristic Participants Randomised (n = 200) Lost to follow-up (n = 21) Exp (n = 97) Con (n = 103) Exp (n = 10) Con (n = 11) Participants Age (yr), mean (SD) 65.1 (7.4) 64.5 (8.3) 62.8 (6.6) 65.1 (8.9) Gender, n males (%) 24 (25) 22 (21) 4 (40) 1 (9) Location of osteoarthritis, n (%) Knee 67 (69) 63 (61) 5 (50) 6 (55) Hip 22 (23) 28 (27) 2 (20) 2 (18) Both knee and hip 8 (8) 12 (12) 3 (30) 3 (27) Duration of complaints, n (%) < 1 year 23 (24) 24 (23) 2 (20) 3 (27) 1 5 years 39 (41) 33 (32) 3 (30) 4 (36) > 5 years 33 (35) 46 (45) 5 (50) 4 (36) Radiological evidence for osteoarthritis, n Kellgren & Lawrence score 2 (%) 56 (74) 45 (64) 4 (67) 3 (60) Co morbidity, n (%) 63 (68) 65 (64) 7 (70) 8 (73) Body Mass Index, mean at baseline (SD) 28.2 (4.2) 28.8 (4.6) 29.4 (4.1) 31.2 (4.4) Pain (0-20), mean at baseline (SD) 9.1 (3.3) 8.7 (3.1) 10.3 (1.9) 8.3 (2.9) Physical function (0-68), mean at baseline (SD) 28.7 (12.5) 29.1 (9.9) 30.3 (10.5) 28.1 (10.9) Exp = experimental group, Con = control group. 115

14 Chapter 5 Table 5.2: Characteristics of therapists and centres Characteristic Exp (n = 26) Con (n = 29) Therapists Age (yr), mean (SD) 40 (7.9) 41 (7.9) Gender, n males (%) 58 (15) 62 (18) - Qualifications, n postgraduate (%) 35 (9) 17 (5) - Experience (yr), mean (SD) 16 (7.3) 16 (7.8) Centres Number Volume participants, mean (SD) 3.7 (3.1) 3.6 (3.0) Effect of interventions Exercise adherence The self-report questionnaire on exercise adherence was filled in by 148 patients (77%) in week 13 and 168 patients (94%) in week 65. In week 13, more missing data on exercise adherence occurred due to the erroneous use of an incomplete questionnaire for a short period during the data-collection. The missing data on exercise adherence were equally distributed between treatment groups, as well on week 13 as week 65. In both treatment groups most patients said they were asked to perform home exercises. Namely, 71 patients (97%) in the experimental and 71 patients (95%) in the control group at 13 weeks follow-up and 79 patients (96%) in the experimental and 72 patients (84%) in the control group at 65 weeks follow-up. Patients in the experimental group reported significantly more frequently to adhere to home exercises compared to patients in the control group, both at 13 and 65 weeks follow-up (see table 5.3). Both at 13 and 65 weeks follow-up, in the experimental group more patients said that they were advised to do home activities compared to the control group. Namely, 70 patients (96%) in the experimental and 54 patients (73%) in the control group at 13 weeks follow-up and 71 patients (88%) in the experimental and 54 patients (66%) in the control group at 65 weeks followup. 116

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16 Chapter 5 Patients in the experimental group reported significantly more frequently to adhere to home activities compared to patients in the control group, at 13 weeks follow-up (see table 5.4). However, at 65 weeks follow-up no significant difference was found between treatment groups. Physical activity In the experimental group significantly more patients met the recommendations for the amount of moderate-vigorous intensity physical activity compared with patients in the control group, both at 13 and 65 weeks follow-up (see table 5.5). Table 5.6 presents patients change compared to baseline in physical activity, for the activities walking, cycling, sports and the total amount of moderate and/or vigorous intensity physical activity. Only in walking time significant differences were found between treatment groups, namely more patients increased in walking time in the experimental group compared with patients in the control group after 13 and 65 weeks. Discussion The results of our study demonstrate that adherence to home exercises and activities was higher in the experimental group compared to the control group, both in the short- and long-term. Furthermore, both in the short- and long-term significantly more patients in the experimental group met the recommendation for the amount of physical activity compared to patients in the control group. The differences in the amount of physical activity between treatment groups in favour of the experimental group were mainly due to an increase in the time spent on walking. The exercise adherence rates in the control group were relatively low in the short- and long-term (respectively 44% and 34%), but comparable with the findings in earlier research. 18 In the experimental group the exercise adherence rate was considerably higher as well in the short- and long-term, namely respectively 75% and 59%. Furthermore, the results of our study show that in both groups the exercise adherence rate declines in the longterm. However, the majority of patients in the experimental group were still adherent in the long-term. 118

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19 Behavioural graded activity results in better exercise adherence In patients with osteoarthritis, lack of regular physical activity is an important risk factor for functional decline. Dunlop et al. 6 demonstrated that lack of regular vigorous physical activity almost doubled the odds of functional decline (after controlling for other risk factors) and found that if all subjects engage in regular vigorous physical activity the expected functional decline could be reduced by as much as 32%. The results of our study show that the level of physical activity was higher in the experimental group than the control group: we found a 5.3 fold (short term) and 2.9 fold (long term) greater odds for meeting the recommendation for the amount of physical activity in patients in the experimental group compared to patients in the control group. The difference between treatment groups was mainly due to an increase in the amount of time patients spent on walking in the experimental group. Although there was a decline in the long-term, similar differences in time spent on walking between the experimental and control group were found in the long term. In the experimental group more patients were advised to perform home activities compared to the control group. This might be an explanation for the difference found in physical activity between treatment groups. Namely, in the experimental group patients most problematic activities were gradually increased and the difference in physical activity between treatment groups was mainly due to an increase in walking time. Earlier research has shown that walking is the most prevalent limitation in activities in patients with osteoarthritis. 41 There are a few limitations to this study that need to be mentioned. First of all, the design of our study does not allow drawing any conclusions on which specific aspect (e.g. boosters sessions) of the experimental treatment is most important for improving exercise adherence and a more physically active lifestyle. Furthermore, a gold standard in measuring exercise adherence does not exist. 42 In this study exercise adherence was measured with a self-report questionnaire. Although widely used, the quality of self-report questionnaires to measure exercise adherence is debatable. They are known to overestimate adherence and susceptible to bias caused by patients memory, social desirability and social approval. 42 It is however unlikely that these potential sources of bias explain the differences in adherence between the experimental and control group, because both groups had similar baseline characteristics. A self-report questionnaire has the advantage that it is a 121

20 Chapter 5 simple method to evaluate exercise adherence. Other possible measures include diaries, interviewing, or more objectively monitoring with a accelerometer. Compliance to diaries over time is poor and diary data have shown to be vulnerable to patient deceit and inaccuracies. Interviews increase the risk for socially desirable answers, while accelerometers/ pedometers are reasonably accurate for measuring walking activities, but can not evaluate other types of movement. For these reasons we decided to use a self-report questionnaire. In conclusion, behavioural graded activity including additional booster sessions results in better exercise adherence and a higher level of physical activity than usual physiotherapy treatment, both in the short- and longterm. Integration of behavioural graded activity principles and additional booster sessions in exercise programs seems to be useful to enhance exercise adherence and patients physical activity after discharge. 122

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24 Chapter 5 (38) Haskell W.L., I-Min L., Pate R.R., Powell K.E., Blair S.N., Franklin B.A. et al. Physical Activity and Public Health: Updated Recommendation for Adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc 2007; 39(8): (39) Nelson M.E., Rejeski W.J., Blair S.N., Duncan P.W., Judge J.O., King A.C. et al. Physical Activity and Public Health in Older Adults: Recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc 2007; 39(8): (40) Cohen J. Statistical power analysis for the behavioral sciences. 2th ed ed. Hillsdale: Lawrence Erlbaum Associates; (41) Ewert T, Fuessl M, Cieza A, Andersen C, Chatterji S, Kostanjsek N et al. Identification of the most common patient problems in patients with chronic conditions using the ICF checklist. J Rehabil Med 2004; Suppl 44: (42) Sluijs EM, van Dulmen S, van Dijk L, de Ridder D, Heerdink R, Bensing J. Patient adherence to medical treatment: a meta review Utrecht, NIVEL. 126

25 Behavioural graded activity results in better exercise adherence Appendix 5.1: Description of the Behavioural Graded Activity (BGA) 127

26 Chapter 5 128

27 Behavioural graded activity results in better exercise adherence Appendix 5.2: Description of the Usual Care (UC) 129

28 130