Physical ActivitySitLESSNCT02629666
Exercise Referral Schemes Enhanced by Self-Management Strategies to Battle Sedentary Behaviour
A study testing ERS and/or Self-management Strategies in people with Physical Activity and Biological Aging, run by University Ramon Llull at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Biological Aging, Frail Older Adults
- What is being tested?
- ERS and/or Self-management Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,360 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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'.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultat de Psicologia, Ciències de l'Educació i de l'Esport Blanquerna
Barcelona, Please Select, 08022
About this study
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
- Being tested
- ERS and/or Self-management Strategies
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERS and/or Self-management StrategiesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sitting time
Sitting time with activity monitors (Actigraph, Axivity, ActivPal) (minutes) and with Sedentary Behavior Questionnaire.
Measured: 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.
Measured: 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.
Measured: 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
Use of sport services, and use of health and social services, medications, number of falls.
Measured: 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
Tanita BC 420S MA bioimpedance analyser.
Measured: 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
SF-12 (units), EUROQOL-5D, and ICECAP-O questionnaires.
Measured: 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
6-item questionnaire (Saliba et al., 2000).
Measured: 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
Hospital Anxiety and Depression Scale
Measured: 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 anxiety symptoms
Hospital Anxiety and Depression Scale
Measured: 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)
Changes in social network
Lubben Social Network Scale-6
Measured: 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)
Changes in Physical activity self-regulation
12-item Physical Activity Self-Regulation Scale
Measured: 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)
Changes in Self-efficacy for exercise
Marcus's Self-Efficacy Questionnaire
Measured: 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)
Changes in Disability
Short form Late Life Function and Disability Index
Measured: 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)
Changes in Fear of falling
Short Falls Efficacy Scale - International
Measured: 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 Loneliness perception
Short form De Jong Gierveld Loneliness Scale
Measured: 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 Executive function
Trail Making Test
Measured: 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 Physical fatigue
Pittsburg Fatigability Scale
Measured: 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 general function
Short Physical Performance Battery
Measured: 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 handgrip strength
Takei analogue Hand Grip Dynamometer
Measured: 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 aerobic capacity
2-minutes' walk test
Measured: 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 static balance
Unipedal stance
Measured: 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 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startJul 2016
- Primary completionOct 2018
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ramon Llull
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Dra. Maria Giné Garriga, University Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629666
- Sponsor's protocol ID
- PHC-17-2014. 634270-2.
- Acronym
- SitLESS
- Status last verified
- Mar 2020
- First submitted
- 19 Nov 2015
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39488430Drahota 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.
PubMed 39360568Bizjak 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.
PubMed 34911479Coll-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.
PubMed 31203243Deidda 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.
PubMed 30327403Gine-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.
PubMed 28521831
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Referral Schemes Enhanced by Self-Management Strategies to Battle Sedentary Behaviour
- ClinicalTrials.gov ID
- NCT02629666
- Acronym / sponsor ID
- SitLESS / PHC-17-2014. 634270-2.
- Conditions
- Physical Activity, Biological Aging, Frail Older Adults, Controlled Clinical Trials, Randomized, Sedentary Behaviour, Exercise Referral Schemes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- University Ramon LlullUniversity, hospital or other
- 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
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Referral Scheme (ERS) | Active comparator | Behavioral: ERS and/or Self-management StrategiesIn 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. |
| ERS + Self-management Strategies | Experimental | Behavioral: ERS and/or Self-management StrategiesParticipants 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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'.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERS and/or Self-management Strategies | Behavioural | ERS + Self-management Strategies, Exercise Referral Scheme (ERS) |
Primary outcome
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.
19 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 39488430Svensson 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.
- Derived from this study: PubMed 39360568Drahota 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.
- Derived from this study: PubMed 34911479Bizjak 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.
- Derived from this study: PubMed 31203243Coll-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.
- Derived from this study: PubMed 30327403Deidda 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.
- Derived from this study: PubMed 28521831Gine-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.
- SitLESS web pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERS and/or Self-management Strategies in people with Physical Activity and Biological Aging, run by University Ramon Llull at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02629666, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.