The SITLESS project: exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: study protocol for a randomised controlled trial

Abstract

BackgroundOlder adults are the fastest growing segment of the world‘s population. Recent evidence indicates that excessive sitting time is harmful to health, independent of meeting the recommended moderate to vigorous physical activity (PA) guidelines. The SITLESS project aims to determine whether exercise referral schemes (ERS) can be enhanced by self-management strategies (SMSs) to reduce sedentary behaviour (SB), increase PA and improve health, quality of life and function in the long term, as well as psychosocial outcomes in community-dwelling older European citizens from four countries, within a three-armed pragmatic randomised controlled trial, compared with ERS alone and also with general recommendations about PA.MethodsA total of 1338 older adults will be included in this study, recruited from four European countries through different existing primary prevention pathways. Participants will be randomly allocated into an ERS of 16 weeks (32 sessions, 45–60 min per session), ERS enhanced by seven sessions of SMSs and four telephone prompts, or a control group. Outcomes will be assessed at baseline, month 4 (end of ERS intervention), month 16 (12 months post intervention) and month 22 (18 months post intervention). Primary outcomes will include measures of SB (time spent sedentary) and PA (counts per minute). Secondary outcomes will include muscle and physical function, health economics’ related outcomes, anthropometry, quality of life, social networks, anxiety and depressive symptoms, disability, fear of falling, executive function and fatigue. A process evaluation will be conducted throughout the trial. The full analysis set will follow an intention-to-treat principle and will include all randomised participants for whom a baseline assessment is conducted. The study hypothesis will be tested with mixed linear models with repeated measures, to assess changes in the main outcomes (SB and PA) over time (baseline to month 22) and between study arms.DiscussionThe findings of this study may help inform the design and implementation of more effective interventions to reduce SB and increase PA levels, and hence improve long-term health outcomes in the older adult population. SITLESS aims to support policy-makers in deciding how or whether ERS should be further implemented or restructured in order to increase its adherence, impact and cost-effectiveness.Trial registrationClinicalTrials.gov, NCT02629666. Registered 19 November 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1956-x) contains supplementary material, which is available to authorized users.

Sedentary behavior, physical activity, and mental health in older adults: An isotemporal substitution model

“…This cross‐sectional analysis is based on baseline data available from the SITLESS study, which is a prospective trial of community‐dwelling men and women aged ≥65 years from Denmark, Spain, Germany, and Northern Ireland 25 . Participants were eligible if they were able to walk for ≥2 minutes (with or without a walking aid), scored four or above on the Short Physical Performance Battery (SPPB), reported undertaking regular MVPA ≤30 minutes on 5 days per week, and/or spend 6‐8 hours per day sitting (eg, watching TV or working at the computer).…”

Nature-Based Social Prescribing in Urban Settings to Improve Social Connectedness and Mental Well-being: a Review

“…The research described in this review covers the theoretical basis and empirical evidence for establishing a green-outdoors bent to social prescribing, which includes reviews of park prescription programs [46], group hiking prescriptions [47], farmers' market prescriptions [48], "Walk with a Doc" programs (https://walkwithadoc.org/), and exercise referral programs [49][50][51]. These social prescriptions take various forms, such as referrals for high-risk patients to weekly, biweekly, or monthly guided outdoor activities with provided transportation [44••, 47], or open-ended, digitally supported prescriptions outlining expected duration, intensity, and frequency of outdoor physical activity [24•].…”

“…The effects are often short-lived [51]. However, the use of social prescribing with enhanced selfmanagement strategies (e.g., individual goal setting, self-monitoring, prompts and cues) have the potential to strengthen the impact of such measures in fostering physical activity behavior change, and in turn, affect mood and feelings of connection if the activities are done within a group context [49,50]. Moreover, these strategies can be linked with nature-based solutions, promoting access to social and natural settings and open spaces [83].…”

Cost-effectiveness of exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: protocol for an economic evaluation alongside the SITLESS three-armed pragmatic randomised controlled trial

“…The estimated sample size to assess overall effectiveness of the intervention in the clinical trial is 1338 subjects (distributed in three intervention groups of 446 participants). 28 This sample size will ensure that it is possible to detect a clinically relevant increase of 30 daily counts per minute (CPM) between the ERS-SMS and the control groups or between the ERS-SMS and the ERS groups.…”