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

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.

Conditions

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

Interventions

BEHAVIORAL

ERS and/or Self-management Strategies

Sponsors & Collaborators

• Fundació Salut i Envelliment de la Universitat Autònoma de Barcelona

  collaborator UNKNOWN

• University of Southern Denmark

  collaborator OTHER

• Queen's University, Belfast

  collaborator OTHER

• University of Ulm

  collaborator OTHER

• Sport Initiative et Loisir Bleu Association

  collaborator UNKNOWN

• University of Glasgow

  collaborator OTHER

• University Ramon Llull

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2018-10-31

Completion

2020-02-29

Countries

• Spain

Study Locations