ExerciseREACTNCT03320746
Enhancing Physical Activity and Healthy Aging Among Recent Retirees
A study testing Polar Loop 2 activity tracker in people with Exercise and Aging, run by University of Turku at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Aging, Retirement
- What is being tested?
- Polar Loop 2 activity tracker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteFinland
- Study dates
- 6 Feb 2018to 1 Mar 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 60 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- current post-operative state or upcoming surgery within the next 6 months
- malign cancer or recent myocardial infraction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Exercise, Aging, Retirement
- Being tested
- Polar Loop 2 activity tracker
- Keywords
- Physical activity, Sedentary time, Intervention, Retiree
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polar Loop 2 activity trackerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Activity trackers | Experimental | 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. Receives: Device: Polar Loop 2 activity tracker |
| No activity trackers | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wake time physical activity
Accelerometer based measurement
Measured: Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.
Secondary outcomes (4)
Change in wake time sedentary activity
Accelerometer based measurement
Measured: Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.
Change in sleep duration and quality
Accelerometer based measurement
Measured: Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.
Change in metabolic profile
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
Measured: Baseline to 12 months
Change in activity locations
GPS-tracking provides data of the latitude, longitude, and time, i.e. when and where an individual is located.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start6 Feb 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland, Juho Vainio Foundation, Ministry of Education and Culture, Finland
- Responsible party
- Principal investigator, Tuija Leskinen, University of Turku
- Investigators
- Sari Stenholm, Prof, Principal investigator, University of TurkuTuija Leskinen, Dr, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320746
- Sponsor's protocol ID
- 309526
- Acronym
- REACT
- Status last verified
- Jun 2020
- First submitted
- 11 Oct 2017
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized partial datasets of the REACT trial are available by application with bona fide researchers with an established scientific record and bona fide organizations.
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.
PubMed 27084334Leskinen 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.
PubMed 29636399Pulakka 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.
PubMed 32150014Myllyntausta 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.
PubMed 31903480Suorsa 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.
PubMed 31095675Myllyntausta 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.
PubMed 30464885Leskinen 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.
PubMed 34261997Pasanen 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.
PubMed 34006539Suorsa 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.
PubMed 33839766
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Physical Activity and Healthy Aging Among Recent Retirees - Randomized Controlled In-home Physical Activity Trial
- ClinicalTrials.gov ID
- NCT03320746
- Acronym / sponsor ID
- REACT / 309526
- Conditions
- Exercise, Aging, Retirement
- Keywords
- Physical activity, Sedentary time, Intervention, Retiree
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Academy of Finland, Juho Vainio Foundation, Ministry of Education and Culture, Finland
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 25 Oct 2017 (actual)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity trackers | Experimental | Device: Polar Loop 2 activity trackerThe participants were requested to wear a commercial wrist-worn activity tracker (Polar Loop 2, Polar, Kempele, Finland) every day and night for 12 months. |
| No activity trackers | No intervention | –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. |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- current post-operative state or upcoming surgery within the next 6 months
- malign cancer or recent myocardial infraction
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 |
|---|---|---|
| Polar Loop 2 activity trackerThe 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. | Device | Activity trackers |
Primary outcome
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.
Accelerometer based measurement
4 secondary outcomes
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.
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.
Change in metabolic profile
Time frame: Baseline to 12 months
Change in activity locations
Time frame: Baseline to 12 months
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 30 Jun 2020.
- Background: PubMed 27084334Stenholm 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.
- Background: PubMed 29636399Leskinen 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.
- Background: PubMed 32150014Pulakka 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.
- Background: PubMed 31903480Myllyntausta 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.
- Background: PubMed 31095675Suorsa 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.
- Background: PubMed 30464885Myllyntausta 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.
- Derived from this study: PubMed 34261997Leskinen 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.
- Derived from this study: PubMed 34006539Pasanen 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.
- Derived from this study: PubMed 33839766Suorsa 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.
- Finnish Retirement and Aging StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized partial datasets of the REACT trial are available by application with bona fide researchers with an established scientific record and bona fide organizations.
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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.
Sari Stenholm, Prof principal investigator
University of Turku
Tuija Leskinen, Dr principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polar Loop 2 activity tracker in people with Exercise and Aging, run by University of Turku at 1 site in Finland.
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 2 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 30 Jun 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 Finland. 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 wake time physical activity (time frame: Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.). 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 NCT03320746, which also lists 9 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 30 Jun 2020.