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

NCT02629666 | Completed

• 1 other identifier: PHC-17-2014. 634270-2.
• Study Type: interventional
• Target: 1,360
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Change in sitting time

  Sitting time with activity monitors (Actigraph, Axivity, ActivPal) (minutes) and with Sedentary Behavior Questionnaire.

  During 7 days. Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention)

• Change in minutes spent in sedentary behaviour

  Number of minutes spent in activities requiring ≤ 1.5 Metabolic Equivalent Tasks with Actigraph activity monitor.

  During 7 days. Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention)

• Change in total activity counts per minute

  Daily counts per minute with Actigraph activity monitor.

  During 7 days. Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention)

Secondary Outcomes (19)

• Change in use and costs of the healthcare system

  Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention)

• Change in % fat and % muscle

  Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention)

• Change in health-related quality of life

  Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention)

• Change in activities of daily living performance

  Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention)

• Change in depressive symptoms

  Outcome measure will be collected (T0) baseline pre-intervention, (T1) at month 4 post intervention, (T2) at month 16 (12 months after the end of the intervention), and (T3) at month 22 (18 months after the end of the intervention)

Other Outcomes (2)

• Level of frailty-associated biomarkers and inflammation

  Outcome measure will be collected (T0) baseline pre-intervention, and (T1) at month 4 post intervention

• Sarcopenia-associated markers of muscle quality

  Outcome measure will be collected (T1) at month 4 post intervention

Study Arms (3)

Exercise Referral Scheme (ERS)

ACTIVE COMPARATOR

In the Exercise Referral Scheme (ERS) intervention participants will undergo a physical activity program of 16 weeks, with two sessions per week (60 minutes each session). Participants will be asked to perform the activity in a moderate to vigorous intensity (according to each individual's progression) during the central part of each session. Intensity will be estimated using the modified Borg Scale of Perceived Exertion (e.g. moderate intensity activity will be considered as a 4 to 6 and vigorous-intensity activity as a 7 to 9) or with training loads (i.e. ankle weights and dumbbells) corresponding to 70-80% of maximum, adjusted progressively during the training period. ERS programs will be based on a combination of aerobic, strength-based, balance and flexibility activities, with a specially trained PA specialist. These sessions will be always performed under the supervision of the same trainer. The PA intervention is adapted to the participants' functional status.

Behavioral: ERS and/or Self-management Strategies

ERS + Self-management Strategies

EXPERIMENTAL

Participants will undergo the aforementioned Physical Activity program plus 11 sessions of Self-Management Strategies (SMS). SMS start with a face-to-face session in an indoor primary-care facility. The next 6 sessions are further implemented in a group format. SMS are aimed at increasing self-efficacy in reducing sedentary behaviour and at adopting/maintaining an active behaviour as complement to a standard physical activity program (ERS). SMS group sessions will be conducted during week 3 to 11 of the ERS, after the PA sessions (6 sessions: 3 once a week, 3 once every second week). There will be 4 telephone contacts during the adherence phase, at week 15, 20, 25 and 30.

Behavioral: ERS and/or Self-management Strategies

Control group

NO INTERVENTION

Researchers will give to all participants during the first informative meeting (prior assessment) a written general booklet standardized across sites with WHO recommendation regarding PA regular practice for health. During the intervention, a health advice meeting with standardized topics about healthy lifestyle and feedback on some outcomes regarding their results will be held twice in the Primary Health Centre (at week 5, and at week 11). Researchers will send a letter or phone call prior to each follow up reminding the next assessment.

Interventions

ERS and/or Self-management Strategies BEHAVIORAL

ERS + Self-management Strategies; Exercise Referral Scheme (ERS)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Community-dwelling older persons aged 65 or above.
• Able to walk without help of another person during 2 minutes, and without major physical limitations, defined as a score on the Short Physical Performance Battery (Guralnik et al., 1995) of 4 or above. The use of an assistive device will be permitted.
• Insufficiently active and/or Self-report sitting too much during a usual day. Answer yes to the following question: 'Do you perform regular physical activity (PA) at least 30 minutes five or more days of the week (please only refer to physical activity that makes the participant run out of breath while doing it or it doesn't allow him/her to maintain a conversation while doing the activity (do not count regular walking)?'
• And/or answer yes to question: 'For most days, do you feel you sit for too long (6-8 hours or more a day)? Some examples might include when watching TV, working the computer / laptop or when doing sitting-based hobbies such as sewing'.

You may not qualify if:

• Dementia assessed with the six-Item Screener. Participants with three or more errors should be excluded.
• Unstable medical conditions (e.g. elevated blood pressure after medication) or with symptomatic cardiovascular disease.
• Any medical condition which may interfere with the study design (e.g. end-stage disease).
• Refuse to wear an accelerometer (primary outcome)
• Unable to attend during the study period (80% of the total sessions).
• Had participated in an ERS in the 6 months prior the study.

Sponsors & Collaborators

• University Ramon Llull: lead
• Fundació Salut i Envelliment de la Universitat Autònoma de Barcelona: collaborator
• University of Southern Denmark: collaborator
• Queen's University, Belfast: collaborator
• University of Ulm: collaborator
• Sport Initiative et Loisir Bleu Association: collaborator
• University of Glasgow: collaborator

Study Sites (1)

Facultat de Psicologia, Ciències de l'Educació i de l'Esport Blanquerna

Barcelona, Please Select, 08022, Spain

Location

Related Publications (6)

• Svensson NH, Thorlund JB, Ollgaard Olsen P, Sondergaard J, Wehberg S, Andersen HS, Caserotti P, Thilsing T. Effect of exercise referral schemes and self-management strategies on healthcare service utilisation among community-dwelling older adults: secondary analyses of two randomised controlled trials. BMJ Open. 2024 Nov 2;14(11):e084938. doi: 10.1136/bmjopen-2024-084938.

  PMID: 39488430 DERIVED

• Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  PMID: 39360568 DERIVED

• Bizjak DA, Zugel M, Schumann U, Tully MA, Dallmeier D, Denkinger M, Steinacker JM. Do skeletal muscle composition and gene expression as well as acute exercise-induced serum adaptations in older adults depend on fitness status? BMC Geriatr. 2021 Dec 15;21(1):697. doi: 10.1186/s12877-021-02666-0.

  PMID: 34911479 DERIVED

• Coll-Planas L, Blancafort Alias S, Tully M, Caserotti P, Gine-Garriga M, Blackburn N, Skjodt M, Wirth K, Deidda M, McIntosh E, Rothenbacher D, Gallardo Rodriguez R, Jerez-Roig J, Sansano-Nadal O, Santiago M, Wilson J, Guerra-Balic M, Martin-Borras C, Gonzalez D, Lefebvre G, Denkinger M, Kee F, Salva Casanovas A, Roque I Figuls M; SITLESS group. Exercise referral schemes enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity among community-dwelling older adults from four European countries: protocol for the process evaluation of the SITLESS randomised controlled trial. BMJ Open. 2019 Jun 14;9(6):e027073. doi: 10.1136/bmjopen-2018-027073.

  PMID: 31203243 DERIVED

• Deidda M, Coll-Planas L, Gine-Garriga M, Guerra-Balic M, Roque I Figuls M, Tully MA, Caserotti P, Rothenbacher D, Salva Casanovas A, Kee F, Blackburn NE, Wilson JJ, Skjodt M, Denkinger M, Wirth K, McIntosh E; SITLESS Team. 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. BMJ Open. 2018 Oct 15;8(10):e022266. doi: 10.1136/bmjopen-2018-022266.

  PMID: 30327403 DERIVED

• Gine-Garriga M, Coll-Planas L, Guerra M, Domingo A, Roque M, Caserotti P, Denkinger M, Rothenbacher D, Tully MA, Kee F, McIntosh E, Martin-Borras C, Oviedo GR, Jerez-Roig J, Santiago M, Sansano O, Varela G, Skjodt M, Wirth K, Dallmeier D, Klenk J, Wilson JJ, Blackburn NE, Deidda M, Lefebvre G, Gonzalez D, Salva A. 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. Trials. 2017 May 18;18(1):221. doi: 10.1186/s13063-017-1956-x.

  PMID: 28521831 DERIVED

Related Links

• SitLESS web page

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (PT, PhD)

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 14, 2015
• Study Start: July 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: February 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

ES (1)