- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03320746
Enhancing Physical Activity and Healthy Aging Among Recent Retirees (REACT)
June 26, 2020 updated by: Tuija Leskinen, University of Turku
Enhancing Physical Activity and Healthy Aging Among Recent Retirees - Randomized Controlled In-home Physical Activity Trial
The purpose of REACT project is to provide cost-effective way to promote physical activity and reduce sedentary time among older adults.
This is done by examining the efficacy of activity tracker based intervention on wake-time physical activity, sedentary time, sleep and other health outcomes among recent retirees.
REACT study will be the first randomized physical activity trial targeted to time window right after retirement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
231
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Turku, Finland, 20520
- University of Turku /Department of Public Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- actual retirement date between Jan 2017 and Dec 2018
- maximum of 12 months from the actual retirement
- capable of doing exercise (able to walk 500 m continuously)
- basic knowledge on how to use computer and Internet access at home
Exclusion Criteria:
- current post-operative state or upcoming surgery within the next 6 months
- malign cancer or recent myocardial infraction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Activity trackers
The participants were requested to wear a commercial wrist-worn activity tracker (Polar Loop 2, Polar, Kempele, Finland) every day and night for 12 months.
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The participants were instructed to aim to reach the daily activity goal, initially set at stage 1 as per the goals set by the trackers' manufacturer.
The daily activity goal was based on user's typical daily activities, gender and age.
The stage 1 daily activity goal corresponded to ~1h/day of jogging or ~2h/day of walking or ~7h/day household activities or a combination of these activities.
The tracker gave an inactivity alert as a vibration and text "it's time to move" on the screen of the tracker if the user has been still for 55 minutes.
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No Intervention: No activity trackers
Control group members were requested to abstain from the use of any type of activity trackers and they were informed that they will receive the activity trackers and guidance for using them after the follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in wake time physical activity
Time Frame: Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.
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Accelerometer based measurement
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Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in wake time sedentary activity
Time Frame: Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.
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Accelerometer based measurement
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Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.
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Change in sleep duration and quality
Time Frame: Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.
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Accelerometer based measurement
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Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.
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Change in metabolic profile
Time Frame: Baseline to 12 months
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Fasting blood sample: lipid profile (total cholesterol, HDL, LDL, triglycerides), fasting plasma glucose, HbA1C, and CRP; blood pressure: systolic and diastolic blood pressure; body composition: fat mass, fat free mass, body weight, waist circumference
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Baseline to 12 months
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Change in activity locations
Time Frame: Baseline to 12 months
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GPS-tracking provides data of the latitude, longitude, and time, i.e. when and where an individual is located.
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Baseline to 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported health
Time Frame: Baseline to 12 months
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Range 1 to 5 "good to poor"
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Baseline to 12 months
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Change in self-reported functioning
Time Frame: Baseline to 12 months
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SF-36 physical functioning, 10 items, subscale range 1 to 3 "health limits a lot to health does not limit at all", total score range 0 to 10 "no to severe limitations"
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Baseline to 12 months
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Change in self-reported well-being
Time Frame: Baseline to 12 months
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GHQ-12, total score range 0 to 12 points, ≥4 points indicates of psychological distress
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Baseline to 12 months
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Change in diet
Time Frame: Baseline to 12 months
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Index of Diet Quality (IDQ) score, total score range 0 to 15 points, ≥10 points indicates of healthy diet
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Baseline to 12 months
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Change in self-reported exercise motivation
Time Frame: Baseline to 12 months
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Short version of Recreational Exercise Motivation Measure (REMM), subscale range 1 to 5 "strongly disagree to strongly agree"
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Baseline to 12 months
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Change in sleep difficulties
Time Frame: Baseline to 12 months
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Jenkins sleep problem scale, subscale range 1 to 6 "not at all to almost every night"
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Baseline to 12 months
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Change in physical activity social support
Time Frame: Baseline to 12 months
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Modified Social Support for Exercise Scale, subscale range 1 to 3 "never to often", mean score 1 to 3 "low to high"
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Baseline to 12 months
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Change in measured functioning
Time Frame: Baseline to 12 months
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Number of chair test repetitions
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Baseline to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sari Stenholm, Prof, University of Turku
- Principal Investigator: Tuija Leskinen, Dr, University of Turku
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stenholm S, Pulakka A, Kawachi I, Oksanen T, Halonen JI, Aalto V, Kivimaki M, Vahtera J. Changes in physical activity during transition to retirement: a cohort study. Int J Behav Nutr Phys Act. 2016 Apr 16;13:51. doi: 10.1186/s12966-016-0375-9.
- Leskinen T, Pulakka A, Heinonen OJ, Pentti J, Kivimaki M, Vahtera J, Stenholm S. Changes in non-occupational sedentary behaviours across the retirement transition: the Finnish Retirement and Aging (FIREA) study. J Epidemiol Community Health. 2018 Aug;72(8):695-701. doi: 10.1136/jech-2017-209958. Epub 2018 Apr 10.
- Pulakka A, Leskinen T, Suorsa K, Pentti J, Halonen JI, Vahtera J, Stenholm S. Physical Activity across Retirement Transition by Occupation and Mode of Commute. Med Sci Sports Exerc. 2020 Sep;52(9):1900-1907. doi: 10.1249/MSS.0000000000002326.
- Myllyntausta S, Pulakka A, Salo P, Kronholm E, Pentti J, Vahtera J, Stenholm S. Changes in accelerometer-measured sleep during the transition to retirement: the Finnish Retirement and Aging (FIREA) study. Sleep. 2020 Jul 13;43(7):zsz318. doi: 10.1093/sleep/zsz318.
- Suorsa K, Pulakka A, Leskinen T, Heinonen I, Heinonen OJ, Pentti J, Vahtera J, Stenholm S. Objectively Measured Sedentary Time Before and After Transition to Retirement: The Finnish Retirement and Aging Study. J Gerontol A Biol Sci Med Sci. 2020 Sep 16;75(9):1737-1743. doi: 10.1093/gerona/glz127.
- Myllyntausta S, Stenholm S. Sleep Before and After Retirement. Curr Sleep Med Rep. 2018;4(4):278-283. doi: 10.1007/s40675-018-0132-5. Epub 2018 Oct 24.
- Leskinen T, Suorsa K, Tuominen M, Pulakka A, Pentti J, Loyttyniemi E, Heinonen I, Vahtera J, Stenholm S. The Effect of Consumer-based Activity Tracker Intervention on Physical Activity among Recent Retirees-An RCT Study. Med Sci Sports Exerc. 2021 Aug 1;53(8):1756-1765. doi: 10.1249/MSS.0000000000002627.
- Pasanen S, Halonen JI, Pulakka A, Kestens Y, Thierry B, Brondeel R, Pentti J, Vahtera J, Leskinen T, Stenholm S. Contexts of sedentary time and physical activity among ageing workers and recent retirees: cross-sectional GPS and accelerometer study. BMJ Open. 2021 May 18;11(5):e042600. doi: 10.1136/bmjopen-2020-042600.
- Suorsa K, Leskinen T, Pulakka A, Pentti J, Loyttyniemi E, Heinonen I, Vahtera J, Stenholm S. The Effect of a Consumer-Based Activity Tracker Intervention on Accelerometer-Measured Sedentary Time Among Retirees: A Randomized Controlled REACT Trial. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):579-587. doi: 10.1093/gerona/glab107.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2018
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
October 11, 2017
First Submitted That Met QC Criteria
October 20, 2017
First Posted (Actual)
October 25, 2017
Study Record Updates
Last Update Posted (Actual)
June 30, 2020
Last Update Submitted That Met QC Criteria
June 26, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 309526
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized partial datasets of the REACT trial are available by application with bona fide researchers with an established scientific record and bona fide organizations.
IPD Sharing Time Frame
2020-2030
IPD Sharing Access Criteria
Anonymized partial datasets of the REACT trial are available by application with bona fide researchers with an established scientific record and bona fide organizations.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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