Periodic Reporting for period 3 - SITless (SITless: Exercise Referral Schemes enhanced by Self-Management Strategies to battle sedentary behaviour)
Berichtszeitraum: 2018-05-01 bis 2020-09-30
Lack of physical activity (PA) and sedentary behaviour (SB) have been associated with the progression of chronic disease and disability in the ageing process. Currently, SB and PA are considered as two independent but related key modifiable life-style factors.
Exercise referral schemes (ERS) are an existing initiative to promote PA in primary care, by referring insufficiently active individuals to an exercise program in sports centre or leisure facility. ERS are generally focussed on PA and rarely target SB. Moreover, ERS have shown short-term improvements in physiologic and functional outcomes as well as in PA, but not in the long-term. Furthermore, guidelines for reducing SB are currently lacking. Psychological approaches focused on self-management strategies have shown increases on self-confidence, power to act, and involvement in exercise and thus promising effects on behaviour change.
Therefore, SITLESS targets both insufficient PA and SB, and has the purpose of enhancing ERS with self-management strategies (SMS) to promote behavioural changes sustained at long-term. Specifically, it aims to determine whether ERS + SMS are more effective reducing SB and increasing PA at 18 months after the intervention in community-dwelling older European citizens from Barcelona, Belfast, Ulm and Odense, than ERS alone or usual care. Secondarily, it aims to assess the impacts on physical function, quality of life and psychosocial outcomes and the cost-effectiveness of the intervention. As recommended, a process evaluation based on quantitative and qualitative procedures was aimed at understanding how implementation, causal mechanisms and the contextual factors shaped the outcomes. The latter also explored the perceived effects of the intervention by the participants and professionals involved.
Finally, SITLESS has the purpose 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.
Exercise referral schemes (ERS) are an existing initiative to promote PA in primary care, by referring insufficiently active individuals to an exercise program in sports centre or leisure facility. ERS are generally focussed on PA and rarely target SB. Moreover, ERS have shown short-term improvements in physiologic and functional outcomes as well as in PA, but not in the long-term. Furthermore, guidelines for reducing SB are currently lacking. Psychological approaches focused on self-management strategies have shown increases on self-confidence, power to act, and involvement in exercise and thus promising effects on behaviour change.
Therefore, SITLESS targets both insufficient PA and SB, and has the purpose of enhancing ERS with self-management strategies (SMS) to promote behavioural changes sustained at long-term. Specifically, it aims to determine whether ERS + SMS are more effective reducing SB and increasing PA at 18 months after the intervention in community-dwelling older European citizens from Barcelona, Belfast, Ulm and Odense, than ERS alone or usual care. Secondarily, it aims to assess the impacts on physical function, quality of life and psychosocial outcomes and the cost-effectiveness of the intervention. As recommended, a process evaluation based on quantitative and qualitative procedures was aimed at understanding how implementation, causal mechanisms and the contextual factors shaped the outcomes. The latter also explored the perceived effects of the intervention by the participants and professionals involved.
Finally, SITLESS has the purpose 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.
The SMS intervention was desgined based on a systematic review on interventions that tackle SB with behaviour change techniques in older adults and focus groups to gather older people’s views on those techniques. A logic model was developed to explain how the proposed SMS intervention tools may influence the study outcomes. A SMS and ERS training manuals were produced taking into account the local and cultural opportunities and differences. The overall study protocol was developed and registered. A feasibility study was conducted. With the results, the intervention, recruitment and evaluation were refined and further adapted to local conditions. Accordingly, the study protocol for the main trial was finalized and published.
A three-armed pragmatic randomised controlled trial was conducted comparing ERS+SMS with ERS alone and also with general recommendations about PA (control group, CG). ActiGraph was used as an activity monitor to objectively assess SB and PA. The four intervention sites recruited 1360 participants.
Variables were assessed at baseline, end of the 16-weeks intervention, 12 and 18-months follow up.
At baseline, older adults spent around 79% of waking time in SB and did an average of 5,000 steps/day. Considering all participants, PA and SB improved over time in the three groups. However, there were no significant differences between the groups at 18-months follow-up. In a second analysis, considering only those participants really doing most of the intervention they were assigned to, results showed that more daily steps a day were done by the SMS-ERS group than the CG or the ERS.
Thus, the ERS+SMS interventions does not seem to be more effective than ERS alone or general recommendations in changing behavior. Nevertheless, significant improvements were found over time on some measures of function and social wellbeing when comparing the ERS+SMS group to the CG.
Process evaluation results showed that the SMS intervention was implemented as planned. There was a high diversity across sites in the settings used and the specific implementation of the PA intervention. Self-regulation and self-efficacy have been seen as mediators that explain the increase on PA and the reduction on SB. Adherence to the intervention and retention to the study have been challenging.
Qualitative results showed that the combination of ERS and SMS did allow personal tailoring of the interventions.
The health economics analysis showed that when compared with ERS alone, SMS+ERS is a cost-effective add on and would reduce healthcare costs. Likewise, the long-term model for the period of 5 years was cost-effective, but no at 15 years.
Complementarily, SITLESS comprised a substudy based on thigh-worn accelerometers and two substudies on blood and muscle biomarkers.
Targeted dissemination activities for the general public, scientific community and policy makers have contributed to raise awareness about the importance of addressing SB in parallel with PA and on the relevance of using behaviour change techniques to sustain long-term effects. The activities include the project website, flyers and several vídeos. The scientific production has been of 11 articles published so far, with several others in preparation, plus multiple presentations in national and International conferences.
The exploitation strategy explored the business opportunities in every intervention site, included a market study and designed the SITLESS product seeking business opportunities. As a result, the final offer is a training aimed to physiotherapists, physical trainers and nurses tailored to the market needs in every country.
A three-armed pragmatic randomised controlled trial was conducted comparing ERS+SMS with ERS alone and also with general recommendations about PA (control group, CG). ActiGraph was used as an activity monitor to objectively assess SB and PA. The four intervention sites recruited 1360 participants.
Variables were assessed at baseline, end of the 16-weeks intervention, 12 and 18-months follow up.
At baseline, older adults spent around 79% of waking time in SB and did an average of 5,000 steps/day. Considering all participants, PA and SB improved over time in the three groups. However, there were no significant differences between the groups at 18-months follow-up. In a second analysis, considering only those participants really doing most of the intervention they were assigned to, results showed that more daily steps a day were done by the SMS-ERS group than the CG or the ERS.
Thus, the ERS+SMS interventions does not seem to be more effective than ERS alone or general recommendations in changing behavior. Nevertheless, significant improvements were found over time on some measures of function and social wellbeing when comparing the ERS+SMS group to the CG.
Process evaluation results showed that the SMS intervention was implemented as planned. There was a high diversity across sites in the settings used and the specific implementation of the PA intervention. Self-regulation and self-efficacy have been seen as mediators that explain the increase on PA and the reduction on SB. Adherence to the intervention and retention to the study have been challenging.
Qualitative results showed that the combination of ERS and SMS did allow personal tailoring of the interventions.
The health economics analysis showed that when compared with ERS alone, SMS+ERS is a cost-effective add on and would reduce healthcare costs. Likewise, the long-term model for the period of 5 years was cost-effective, but no at 15 years.
Complementarily, SITLESS comprised a substudy based on thigh-worn accelerometers and two substudies on blood and muscle biomarkers.
Targeted dissemination activities for the general public, scientific community and policy makers have contributed to raise awareness about the importance of addressing SB in parallel with PA and on the relevance of using behaviour change techniques to sustain long-term effects. The activities include the project website, flyers and several vídeos. The scientific production has been of 11 articles published so far, with several others in preparation, plus multiple presentations in national and International conferences.
The exploitation strategy explored the business opportunities in every intervention site, included a market study and designed the SITLESS product seeking business opportunities. As a result, the final offer is a training aimed to physiotherapists, physical trainers and nurses tailored to the market needs in every country.
Participants benefit from reductions in health risk through reductions in SB and increases in PA, improved their physical, mental and social functioning, quality of life and wellbeing, especially among those from the ERS+SMS. They maintained their lifestyle changes overtime. The study increased the interactions of the participants from the ERS and the ERS+SMS with their social and physical environment, through the local offer of facilities and activities to promote a physically active lifestyle, as well as through self-organized activities within their social networks.
The clinical trial results are useful to improve the design and delivery of ERS as an existing intervention.
SITLESS results are contributing to bridge the gap between the current recommendations on physical exercise formulated by WHO and scientific societies and adopted by national and local policy makers, and the actual behaviour of older people.
The current focus on adressing the SARS-CoV-2 Pandemic challenges the translation of the project results. Nevertheless, public administrations are deeply concerned with the vulnerability of older people and how to enhance their health. Furthermore, lockdown measures, along with other restrictions of social interaction have multiplied sedentary behaviours and lack of physical activity, particularly in the more vulnerable older adults. The SITLESS intervention has a great potential to revert this situation in the near future.
The clinical trial results are useful to improve the design and delivery of ERS as an existing intervention.
SITLESS results are contributing to bridge the gap between the current recommendations on physical exercise formulated by WHO and scientific societies and adopted by national and local policy makers, and the actual behaviour of older people.
The current focus on adressing the SARS-CoV-2 Pandemic challenges the translation of the project results. Nevertheless, public administrations are deeply concerned with the vulnerability of older people and how to enhance their health. Furthermore, lockdown measures, along with other restrictions of social interaction have multiplied sedentary behaviours and lack of physical activity, particularly in the more vulnerable older adults. The SITLESS intervention has a great potential to revert this situation in the near future.