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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - SITless (SITless: Exercise Referral Schemes enhanced by Self-Management Strategies to battle sedentary behaviour)

Teaser

Summary

Ageing is associated with an increased risk of frailty, functional loss and poor health outcomes. Lack of physical activity (PA) and sedentary behaviour (SB) have been associated with the progression of chronic disease and disability and are currently considered as two key modifiable life-style factors.

An existing initiative to battle insufficient PA levels are exercise referral schemes (ERS). ERS are implemented in primary care, where insufficiently active individuals are referred to a sports centre or leisure facility that prescribes and monitors an exercise program tailored to the individualsâ€™ needs. ERS are generally 12-16 weeks long, generally focussed on physical (in)activity and rarely target SB. Moreover, ERS have shown short-term improvements in physiologic and functional outcomes as well as in PA but limited effect maintaining these improvements in the long-term. Furthermore, guidelines for reducing SB are currently lacking. Strategies based on psychological approaches have been shown to increase self-confidence, power to act, and involvement in exercise.

Therefore, SITLESS targets lack of exercise, PA and SB as combined risk factors, and aims at identifying whether ERS enhanced by self-management strategies (SMS) may promote behavioural change and thus sustain long-term life-style changes. In a first stage, 2 systematic reviews, focus groups and a feasibility study were conducted in order to keep track with current scientific and societal progress and regional peculiarities. Currently, a three-armed pragmatic randomized controlled trial (RCT) is assessing the long-term effectiveness of a complex intervention on SB in an elderly population, based on existing ERS enhanced by SMS. This intervention will be compared to ERS alone and to general recommendations (control group). This trial aims to include 1338 participants and will have a follow up of 18 months after the end of the ERS. Using an activity monitor, the effect on SB will be measured as time spent in this behaviour and the effect on PA will be assessed as amount of activity measured as daily counts per minute. Secondary outcomes include: physical function, disability in activities of daily living, physical fatigue, body composition, blood pressure, self-rated health and quality of life, anxiety and depressive symptoms, social network, loneliness, physical activity self-regulation, confidence in being physically active, fear of falling, executive functions, healthcare use and costs. SITLESS, as a pragmatic trial based on a complex intervention, includes a process evaluation to take into account implementation, context and mechanisms of impact. It also involves a health economics analysis to assess cost-effectiveness. 2 sub-studies focus on biomarkers: A) evaluates inflammation and frailty-associated blood biomarkers, B) investigates sarcopenia-associated markers of muscle quality by removing muscle tissues. Last, 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.

Work performed

SITLESS, as a Responsible Research and Innovation project, has created guidance for the involvement of stakeholders in the project from the onset. Accordingly, local advisory boards were created on each intervention site (Barcelona, Odense, Belfast, Ulm) and are periodically involved in the study. A gender expert linked to the European project EGERA is part of the advisory board of Barcelona.

The SMS intervention was built using a number of initial steps. Work started undertaking a systematic review on interventions that tackle SB with behaviour change techniques in older adults. Focus groups were conducted in the intervention sites to gather older peopleâ€™s views on the behavioural change techniques identified from the review, which may be used in the SMS intervention. With this background knowledge, a logic model was developed to understand how the proposed SMS intervention tools may influence the study outcomes. A SMS training manual was produced. The overall study protocol was developed. A PA manual for the trainers was elaborated to define a common ground on how to conduct the ERS intervention taking into account the local and cultural opportunities and differences. A feasibility study was conducted testing the three arms to set the basis for the recruitment and evaluation procedures for the main trial. A process evaluation, combining qualitative and quantitative procedures was used to highlight any potential challenges. Data on health costs were also collected to test the proposed measures of cost-effectiveness. With the results from the feasibility study, the intervention, recruitment and evaluation have been refined, improved and further adapted to local and country specific conditions. Accordingly, the study protocol has been finalized. The main trial is currently underway in the four intervention sites. Instructors have been trained while recruitment and baseline assessments are ongoing. The first intervention groups have started. As part of the main trial, a process evaluation has been detailed to assess the quality of the implementation and to identify how useful the intervention is and the possible factors that might have an impact on the intervention or on the results.

Furthermore, a second systematic review was conducted on any biomarkers related with SB. The review was accepted in a peer-reviewed scientific journal. 2 sub-studies protocols have been prepared to explore biomarkers in blood and in muscle related to SB in a subsample of the main trial. Business opportunities have been explored across the European countries involved in SITLESS to start building a SITLESS service model.

Final results

The progress beyond the state of the art is currently limited to the actions and outputs initially generated in order to develop the main trial, which has just started. So far, SITLESS has generated an intervention model to address SB and PA for community-dwelling older people that appears to be feasible in 4 European countries with different cultural values and health care systems. Both the systematic reviews are innovative and allow research on SB to move forward in terms of greater understanding on how to develop and assess effective interventions. The systematic review on biomarkers related with SB will be soon available: Wirth K et al. Biomarkers associated with sedentary behaviour in older adults: a systematic review. Ageing Research Reviews 2016; 10.1016/j.arr.2016.12.002. Dissemination activities have contributed to raise awareness and generate a public, scientific and policy debate about the importance of addressing SB in parallel with PA and on the relevance of using behaviour change techniques to sustain long-term effects. Local advisory boards have allowed to create local networks of a diversity of stakeholders and to implement responsible research innovation. The participation of advisory board members in the Consortium meetings has enriched SITLESS and allowed sharing of local experiences, ideas and perspectives in an international setting. SITLESS will contribute to understanding how cost-effective this model might be if implemented on a larger scale. The exploitation plan aims to impact the growing market of helping older people become more active.