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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02629666
Acronym
SitLESS
Enrollment
1360
Registered
2015-12-14
Start date
2016-07-31
Completion date
2020-02-29
Last updated
2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALERS and/or Self-management Strategies

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in total activity counts per minuteDuring 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)Daily counts per minute with Actigraph activity monitor.
Change in minutes spent in sedentary behaviourDuring 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)Number of minutes spent in activities requiring ≤ 1.5 Metabolic Equivalent Tasks with Actigraph activity monitor.
Change in sitting timeDuring 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)Sitting time with activity monitors (Actigraph, Axivity, ActivPal) (minutes) and with Sedentary Behavior Questionnaire.

Secondary

MeasureTime frameDescription
Change in health-related quality of lifeOutcome 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)SF-12 (units), EUROQOL-5D, and ICECAP-O questionnaires.
Change in activities of daily living performanceOutcome 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)6-item questionnaire (Saliba et al., 2000).
Change in depressive symptomsOutcome 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)Hospital Anxiety and Depression Scale
Change in anxiety symptomsOutcome 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)Hospital Anxiety and Depression Scale
Changes in social networkOutcome 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)Lubben Social Network Scale-6
Changes in Physical activity self-regulationOutcome 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)12-item Physical Activity Self-Regulation Scale
Changes in Self-efficacy for exerciseOutcome 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)Marcus's Self-Efficacy Questionnaire
Changes in DisabilityOutcome 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)Short form Late Life Function and Disability Index
Change in Loneliness perceptionOutcome 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)Short form De Jong Gierveld Loneliness Scale
Change in Executive functionOutcome 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)Trail Making Test
Change in Physical fatigueOutcome 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)Pittsburg Fatigability Scale
Change in general functionOutcome 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)Short Physical Performance Battery
Change in handgrip strengthOutcome 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)Takei analogue Hand Grip Dynamometer
Change in aerobic capacityOutcome 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)2-minutes' walk test
Change in static balanceOutcome 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)Unipedal stance
Change in mean strength and power with concentric contraction of isoinertial movementOutcome 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)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.
Changes in Fear of fallingOutcome 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)Short Falls Efficacy Scale - International
Change in use and costs of the healthcare systemOutcome 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)Use of sport services, and use of health and social services, medications, number of falls.
Change in % fat and % muscleOutcome 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)Tanita BC 420S MA bioimpedance analyser.

Other

MeasureTime frameDescription
Level of frailty-associated biomarkers and inflammationOutcome measure will be collected (T0) baseline pre-intervention, and (T1) at month 4 post interventionBlood sample: IL-6, hsCRP, TNF-alpha, IGF-1.
Sarcopenia-associated markers of muscle qualityOutcome measure will be collected (T1) at month 4 post interventionMuscle biopsy: Myostatin, IL-6, IL-8, IL-15, VEGF, BDNF, FGF21, irisin, Type 2/Type 1 fibre ratio, Wnt and Notch signaling, CDC42.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026