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

This study is currently recruiting participants.
Verified February 2017 by Dra. Maria Giné Garriga, University Ramon Llull
Sponsor:
ClinicalTrials.gov Identifier:
NCT02629666
First Posted: December 14, 2015
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Fundació Salut i Envelliment de la Universitat Autònoma de Barcelona
University of Southern Denmark
Queen's University, Belfast
University of Ulm
Sport Initiative et Loisir Bleu Association
University of Glasgow
Information provided by (Responsible Party):
Dra. Maria Giné Garriga, University Ramon Llull
  Purpose
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.

Condition Intervention
Physical Activity Biological Aging Frail Older Adults Controlled Clinical Trials, Randomized Sedentary Behaviour Exercise Referral Schemes Physical Function Behavioral: ERS and/or Self-management Strategies

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Exercise Referral Schemes Enhanced by Self-Management Strategies to Battle Sedentary Behaviour

Resource links provided by NLM:


Further study details as provided by Dra. Maria Giné Garriga, University Ramon Llull:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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).

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcome Measures:
  • 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.

  • 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.


Estimated Enrollment: 1338
Study Start Date: July 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise Referral Scheme (ERS)
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
Experimental: ERS + Self-management Strategies

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
No Intervention: Control group
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629666


Contacts
Contact: Maria Giné-Garriga, PT, PhD 932533000 mariagg@blanquerna.url.edu

Locations
Spain
Facultat de Psicologia, Ciències de l'Educació i de l'Esport Blanquerna Recruiting
Barcelona, Please Select, Spain, 08022
Contact: Maria Giné-Garriga, PT, PhD    932533000    mariagg@blanquerna.url.edu   
Contact: Míriam Guerra-Balic, MD, PhD    932533000    miriamelisagb@blanquerna.url.edu   
Sub-Investigator: Carme Martin Borràs, PT, PhD         
Sponsors and Collaborators
University Ramon Llull
Fundació Salut i Envelliment de la Universitat Autònoma de Barcelona
University of Southern Denmark
Queen's University, Belfast
University of Ulm
Sport Initiative et Loisir Bleu Association
University of Glasgow
  More Information

Additional Information:
Responsible Party: Dra. Maria Giné Garriga, Professor (PT, PhD), University Ramon Llull
ClinicalTrials.gov Identifier: NCT02629666     History of Changes
Other Study ID Numbers: PHC-17-2014. 634270-2.
First Submitted: November 19, 2015
First Posted: December 14, 2015
Last Update Posted: February 27, 2017
Last Verified: February 2017