Exercise Referral Schemes Enhanced by Self-Management Strategies to Battle Sedentary Behaviour

Study Overview
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Brief Summary
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The increase of the elderly population leads to increased prevalence of frailty, risk for poor health outcomes, and related health and social care costs. Lack of physical activity (PA) and established sedentary behaviours (SB) constitute an additional burden, as they are related to progression of chronic disease and disabling conditions. An existing initiative to battle SB and insufficient PA levels are exercise referral schemes (ERS) implemented in primary care, where insufficiently active individuals are referred to a third party service (sports centre or leisure facility) that prescribes and monitors an exercise programme tailored to the patients' needs. ERS had shown improvements in PA in the short-term, but may have limited power to change SB and produce long-term effects. Thus, ERS might be enhanced by self-management strategies (SMS) to promote behavioural change. Such strategies based on social cognitive theory have been shown to increase self-confidence, power to act, and involvement in exercise. In a first stage, a systematic review, focus groups and a feasibility study will be conducted. Then, a three-armed pragmatic randomized controlled trial (RCT) will assess the long-term effectiveness (18-month follow-up) of a complex intervention on sedentary behaviour (SB) in an elderly population, based on existing ERS enhanced by self-management strategies (SMS). It will be compared to ERS alone and to general recommendations plus two educational sessions. The RCT will include 1338 subjects and will have a follow up of 18 months. The effect on SB will be measured as sitting time and the number of minutes spent in activities requiring ≤ 1.5 Metabolic Equivalent Tasks, and PA as daily counts per minute and intensity of exercise, and daily step counts. Secondary outcomes will include: physical function, healthcare use and costs, anthropometry, bioimpedance, blood pressure, self-rated health and quality of life, activities of daily living, anxiety, depressive symptoms, social network, physical activity self-regulation, self-efficacy for exercise, disability, fear of falling, loneliness, executive function, and physical fatigue. In a subsample, the level of frailty-associated biomarkers and inflammation, and sarcopenia-associated markers of muscle quality will be analysed. A process evaluation will be performed throughout the trial. SITLESS will assess policy makers in deciding how or whether ERS should be further implemented or restructured in order to increase its adherence, efficacy and cost-effectiveness.

Official Title
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Exercise Referral Schemes Enhanced by Self-Management Strategies to Battle Sedentary Behaviour

Conditions
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Physical Activity, Biological Aging, Frail Older Adults, Controlled Clinical Trials, Randomized, Sedentary Behaviour, Exercise Referral Schemes, Physical Function

Intervention / Treatment
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* Behavioral: ERS and/or Self-management Strategies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling older persons aged 65 or above. Able to walk without help of another person during 2 minutes, and without major physical limitations, defined as a score on the Short Physical Performance Battery (Guralnik et al., 1995) of 4 or above. The use of an assistive device will be permitted. Insufficiently active and/or Self-report sitting too much during a usual day. Answer yes to the following question: 'Do you perform regular physical activity (PA) at least 30 minutes five or more days of the week (please only refer to physical activity that makes the participant run out of breath while doing it or it doesn't allow him/her to maintain a conversation while doing the activity (do not count regular walking)?' And/or answer yes to question: 'For most days, do you feel you sit for too long (6-8 hours or more a day)? Some examples might include when watching TV, working the computer / laptop or when doing sitting-based hobbies such as sewing'. Exclusion Criteria: Dementia assessed with the six-Item Screener. Participants with three or more errors should be excluded. Unstable medical conditions (e.g. elevated blood pressure after medication) or with symptomatic cardiovascular disease. Any medical condition which may interfere with the study design (e.g. end-stage disease). Refuse to wear an accelerometer (primary outcome) Unable to attend during the study period (80% of the total sessions). Had participated in an ERS in the 6 months prior the study.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Referral Scheme (ERS)<br>In the Exercise Referral Scheme (ERS) intervention participants will undergo a physical activity program of 16 weeks, with two sessions per week (60 minutes each session). Participants will be asked to perform the activity in a moderate to vigorous intensity (according to each individual's progression) during the central part of each session. Intensity will be estimated using the modified Borg Scale of Perceived Exertion (e.g. moderate intensity activity will be considered as a 4 to 6 and vigorous-intensity activity as a 7 to 9) or with training loads (i.e. ankle weights and dumbbells) corresponding to 70-80% of maximum, adjusted progressively during the training period. ERS programs will be based on a combination of aerobic, strength-based, balance and flexibility activities, with a specially trained PA specialist. These sessions will be always performed under the supervision of the same trainer. The PA intervention is adapted to the participants' functional status. | Behavioral: ERS and/or Self-management Strategies<br> <br> |
| Experimental: ERS + Self-management Strategies<br>Participants will undergo the aforementioned Physical Activity program plus 11 sessions of Self-Management Strategies (SMS). SMS start with a face-to-face session in an indoor primary-care facility. The next 6 sessions are further implemented in a group format. SMS are aimed at increasing self-efficacy in reducing sedentary behaviour and at adopting/maintaining an active behaviour as complement to a standard physical activity program (ERS). SMS group sessions will be conducted during week 3 to 11 of the ERS, after the PA sessions (6 sessions: 3 once a week, 3 once every second week). There will be 4 telephone contacts during the adherence phase, at week 15, 20, 25 and 30. | Behavioral: ERS and/or Self-management Strategies<br> <br> |
| No Intervention: Control group<br>Researchers will give to all participants during the first informative meeting (prior assessment) a written general booklet standardized across sites with WHO recommendation regarding PA regular practice for health. During the intervention, a health advice meeting with standardized topics about healthy lifestyle and feedback on some outcomes regarding their results will be held twice in the Primary Health Centre (at week 5, and at week 11). Researchers will send a letter or phone call prior to each follow up reminding the next assessment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sitting time | Sitting time with activity monitors (Actigraph, Axivity, ActivPal) (minutes) and with Sedentary Behavior Questionnaire. | During 7 days. Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in minutes spent in sedentary behaviour | Number of minutes spent in activities requiring ≤ 1.5 Metabolic Equivalent Tasks with Actigraph activity monitor. | During 7 days. Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in total activity counts per minute | Daily counts per minute with Actigraph activity monitor. | During 7 days. Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in use and costs of the healthcare system | Use of sport services, and use of health and social services, medications, number of falls. | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in % fat and % muscle | Tanita BC 420S MA bioimpedance analyser. | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in health-related quality of life | SF-12 (units), EUROQOL-5D, and ICECAP-O questionnaires. | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in activities of daily living performance | 6-item questionnaire (Saliba et al., 2000). | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in depressive symptoms | Hospital Anxiety and Depression Scale | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in anxiety symptoms | Hospital Anxiety and Depression Scale | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Changes in social network | Lubben Social Network Scale-6 | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Changes in Physical activity self-regulation | 12-item Physical Activity Self-Regulation Scale | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Changes in Self-efficacy for exercise | Marcus's Self-Efficacy Questionnaire | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Changes in Disability | Short form Late Life Function and Disability Index | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Changes in Fear of falling | Short Falls Efficacy Scale - International | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in Loneliness perception | Short form De Jong Gierveld Loneliness Scale | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in Executive function | Trail Making Test | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in Physical fatigue | Pittsburg Fatigability Scale | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in general function | Short Physical Performance Battery | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in handgrip strength | Takei analogue Hand Grip Dynamometer | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in aerobic capacity | 2-minutes' walk test | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in static balance | Unipedal stance | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) | 
| Change in mean strength and power with concentric contraction of isoinertial movement | Linear encoder in 3 activities of daily living with: (a) 30-second chair stand rise; (b) five repetitions of arm curl with both hands with a 2-kg weight; and (c) four counter-movement jumps. | Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention) |