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Completed

NCT Number: NCT02629666

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Barcelona, Please Select, 08022, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERS and/or Self-management Strategies

Behavioral

Primary outcomes

  1. Change in sitting time

    Time frame: 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)

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

  2. Change in minutes spent in sedentary behaviour

    Time frame: 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)

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

  3. Change in total activity counts per minute

    Time frame: 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)

    Daily counts per minute with Actigraph activity monitor.

Secondary outcomes

  1. Change in use and costs of the healthcare system

    Time frame: 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)

    Use of sport services, and use of health and social services, medications, number of falls.

  2. Change in % fat and % muscle

    Time frame: 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)

    Tanita BC 420S MA bioimpedance analyser.

  3. Change in health-related quality of life

    Time frame: 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)

    SF-12 (units), EUROQOL-5D, and ICECAP-O questionnaires.

  4. Change in activities of daily living performance

    Time frame: 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)

    6-item questionnaire (Saliba et al., 2000).

  5. Change in depressive symptoms

    Time frame: 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)

    Hospital Anxiety and Depression Scale

  6. Change in anxiety symptoms

    Time frame: 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)

    Hospital Anxiety and Depression Scale

  7. Changes in social network

    Time frame: 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)

    Lubben Social Network Scale-6

  8. Changes in Physical activity self-regulation

    Time frame: 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)

    12-item Physical Activity Self-Regulation Scale

  9. Changes in Self-efficacy for exercise

    Time frame: 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)

    Marcus's Self-Efficacy Questionnaire

  10. Changes in Disability

    Time frame: 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)

    Short form Late Life Function and Disability Index

  11. Changes in Fear of falling

    Time frame: 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)

    Short Falls Efficacy Scale - International

  12. Change in Loneliness perception

    Time frame: 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)

    Short form De Jong Gierveld Loneliness Scale

  13. Change in Executive function

    Time frame: 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)

    Trail Making Test

  14. Change in Physical fatigue

    Time frame: 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)

    Pittsburg Fatigability Scale

  15. Change in general function

    Time frame: 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)

    Short Physical Performance Battery

  16. Change in handgrip strength

    Time frame: 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)

    Takei analogue Hand Grip Dynamometer

  17. Change in aerobic capacity

    Time frame: 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)

    2-minutes' walk test

  18. Change in static balance

    Time frame: 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)

    Unipedal stance

  19. Change in mean strength and power with concentric contraction of isoinertial movement

    Time frame: 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)

    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.

Other outcomes

  1. Level of frailty-associated biomarkers and inflammation

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

    Blood sample: IL-6, hsCRP, TNF-alpha, IGF-1.

  2. Sarcopenia-associated markers of muscle quality

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

    Muscle biopsy: Myostatin, IL-6, IL-8, IL-15, VEGF, BDNF, FGF21, irisin, Type 2/Type 1 fibre ratio, Wnt and Notch signaling, CDC42.

Sponsors and collaborators

Lead sponsor

University Ramon Llull

Other

Collaborators

  • 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

Registry information

Acronym: SitLESS

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Dec 14, 2015
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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