Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Exercise Referral Schemes Enhanced by Self-Management Strategies to Battle Sedentary Behaviour
Brief Summary: 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.


Options:
A: Arm Label: Exercise Referral Scheme (ERS); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: ERS and/or Self-management Strategies | Arm Label: ERS + Self-management Strategies; Type: EXPERIMENTAL; Interventions: Behavioral: ERS and/or Self-management Strategies | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: ERS and/or Self-management Strategies; Assigned to Arm(s): ERS + Self-management Strategies, Exercise Referral Scheme (ERS)
B: Arm Label: AP+CP+M; Type: EXPERIMENTAL; Interventions: Behavioral: Action planning, Behavioral: Coping planning, Behavioral: Self-monitoring, Behavioral: Feedback and tips | Arm Label: AP+CP; Type: EXPERIMENTAL; Interventions: Behavioral: Action planning, Behavioral: Coping planning, Behavioral: Feedback and tips | Arm Label: AP+M; Type: EXPERIMENTAL; Interventions: Behavioral: Action planning, Behavioral: Self-monitoring, Behavioral: Feedback and tips | Arm Label: CP+M; Type: EXPERIMENTAL; Interventions: Behavioral: Coping planning, Behavioral: Self-monitoring, Behavioral: Feedback and tips | Arm Label: M; Type: EXPERIMENTAL; Interventions: Behavioral: Self-monitoring, Behavioral: Feedback and tips | Arm Label: CP; Type: EXPERIMENTAL; Interventions: Behavioral: Coping planning, Behavioral: Feedback and tips | Arm Label: AP; Type: EXPERIMENTAL; Interventions: Behavioral: Action planning, Behavioral: Feedback and tips | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Feedback and tips | Intervention Type: BEHAVIORAL; Name: Action planning; Assigned to Arm(s): AP, AP+CP, AP+CP+M, AP+M | Intervention Type: BEHAVIORAL; Name: Coping planning; Assigned to Arm(s): AP+CP, AP+CP+M, CP, CP+M | Intervention Type: BEHAVIORAL; Name: Self-monitoring; Assigned to Arm(s): AP+CP+M, AP+M, CP+M, M | Intervention Type: BEHAVIORAL; Name: Feedback and tips; Assigned to Arm(s): AP, AP+CP, AP+CP+M, AP+M, CP, CP+M, Control, M
C: Arm Label: Physical Activity Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Physical Activity Intervention | Arm Label: Wellness Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Wellness Control | Intervention Type: BEHAVIORAL; Name: Physical Activity Intervention; Assigned to Arm(s): Physical Activity Intervention | Intervention Type: BEHAVIORAL; Name: Wellness Control; Assigned to Arm(s): Wellness Control
D: Arm Label: Lifestyle change; Type: EXPERIMENTAL; Interventions: Behavioral: Reduction of sedentary time by breaking it with low intensity physical activity | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Reduction of sedentary time by breaking it with low intensity physical activity; Assigned to Arm(s): Lifestyle change

Answer: A