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

Physical Activity Clinical Trial

— SitLESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629666
• Other study ID #: PHC-17-2014. 634270-2.
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: February 2020

Study information

• Verified date: March 2020
• Source: University Ramon Llull
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1360
• Est. completion date: February 2020
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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'.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• ERS and/or Self-management Strategies

Locations

Country	Name	City	State
Spain	Facultat de Psicologia, Ciències de l'Educació i de l'Esport Blanquerna	Barcelona	Please Select

Sponsors (7)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of frailty-associated biomarkers and inflammation	Blood sample: IL-6, hsCRP, TNF-alpha, IGF-1.	Outcome measure will be collected (T0) baseline pre-intervention, and (T1) at month 4 post intervention
Other	Sarcopenia-associated markers of muscle quality	Muscle biopsy: Myostatin, IL-6, IL-8, IL-15, VEGF, BDNF, FGF21, irisin, Type 2/Type 1 fibre ratio, Wnt and Notch signaling, CDC42.	Outcome measure will be collected (T1) at month 4 post intervention
Primary	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)
Primary	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)
Primary	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	Change in use and costs of the healthcare system	Use of sport services, and use of health and social services, medications, number of falls.	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	Change in % fat and % muscle	Tanita BC 420S MA bioimpedance analyser.	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	Change in health-related quality of life	SF-12 (units), EUROQOL-5D, and ICECAP-O questionnaires.	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	Change in activities of daily living performance	6-item questionnaire (Saliba et al., 2000).	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	Change in depressive symptoms	Hospital Anxiety and Depression Scale	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	Change in anxiety symptoms	Hospital Anxiety and Depression Scale	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	Changes in social network	Lubben Social Network Scale-6	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	Changes in Physical activity self-regulation	12-item Physical Activity Self-Regulation Scale	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	Changes in Self-efficacy for exercise	Marcus's Self-Efficacy Questionnaire	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	Changes in Disability	Short form Late Life Function and Disability Index	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	Changes in Fear of falling	Short Falls Efficacy Scale - International	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	Change in Loneliness perception	Short form De Jong Gierveld Loneliness Scale	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	Change in Executive function	Trail Making Test	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	Change in Physical fatigue	Pittsburg Fatigability Scale	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	Change in general function	Short Physical Performance Battery	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	Change in handgrip strength	Takei analogue Hand Grip Dynamometer	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	Change in aerobic capacity	2-minutes' walk test	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	Change in static balance	Unipedal stance	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	Change in mean strength and power with concentric contraction of isoinertial movement	Linear encoder in 3 activities of daily living with: (a) 30-second chair stand rise; (b) five repetitions of arm curl with both hands with a 2-kg weight; and (c) four counter-movement jumps.	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)

External Links

•   SitLESS web page