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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
231

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Finland
      • Turku, Finland, 20520
        • University of Turku /Department of Public Health

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Polar Loop 2 activity tracker
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Accelerometer based measurement
Primarily change from baseline to 12 months, secondarily change from baseline to 3 months and to 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Accelerometer based measurement
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.
Accelerometer based measurement
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
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
Baseline to 12 months
Change in activity locations
Time Frame: Baseline to 12 months
GPS-tracking provides data of the latitude, longitude, and time, i.e. when and where an individual is located.
Baseline to 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in self-reported health
Time Frame: Baseline to 12 months
Range 1 to 5 "good to poor"
Baseline to 12 months
Change in self-reported functioning
Time Frame: Baseline to 12 months
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"
Baseline to 12 months
Change in self-reported well-being
Time Frame: Baseline to 12 months
GHQ-12, total score range 0 to 12 points, ≥4 points indicates of psychological distress
Baseline to 12 months
Change in diet
Time Frame: Baseline to 12 months
Index of Diet Quality (IDQ) score, total score range 0 to 15 points, ≥10 points indicates of healthy diet
Baseline to 12 months
Change in self-reported exercise motivation
Time Frame: Baseline to 12 months
Short version of Recreational Exercise Motivation Measure (REMM), subscale range 1 to 5 "strongly disagree to strongly agree"
Baseline to 12 months
Change in sleep difficulties
Time Frame: Baseline to 12 months
Jenkins sleep problem scale, subscale range 1 to 6 "not at all to almost every night"
Baseline to 12 months
Change in physical activity social support
Time Frame: Baseline to 12 months
Modified Social Support for Exercise Scale, subscale range 1 to 3 "never to often", mean score 1 to 3 "low to high"
Baseline to 12 months
Change in measured functioning
Time Frame: Baseline to 12 months
Number of chair test repetitions
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Turku

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Academy of Finland
Juho Vainio Foundation
Ministry of Education and Culture, Finland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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