Renewing Caregiver Health and Well-being Through Exercise (RECHARGE)

October 24, 2016 updated by: Dr. Nicole Culos-Reed, University of Calgary

Renewing Caregiver Health and Well-being Through Exercise: A Randomized Controlled Trial

The RECHARGE study is evaluating the effect of a 24 week structured exercise and education program on the physical and emotion health, quality of life, physical activity and fitness levels of family caregivers. Very little research has been done examining the impact of a structured exercise program designed for family caregivers of cancer patients. The purpose of this study is to determine if physical activity is effective in improving caregiver health and well-being.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The REHCARGE study is a randomized control trial testing a structured exercise program for cancer family caregivers. One half of the participants enrolled will receive no exercise program until after twelve weeks have passed (the delayed start group) and the other half of the participants will start the exercise program right away. In addition to regular attendance at exercise classes, participants will also be asked to complete some measurements throughout the study including an initial assessment and one after 12 weeks and 24 weeks of the exercise programs. If participants are a part of the delayed start group, they will receive a fourth fitness assessment. Assessments include an evaluation of physical activity levels, quality of life, depression, sleep, and social support through survey type questionnaires as well as a fitness assessment to measure overall fitness and body composition. Participants will receive an individualized exercise program appropriate for their fitness level as well as 6 education sessions about healthy behaviors throughout the study.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary Health and Wellness Lab

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently providing physical care, instrumental or psychological support to an adult patient who has been diagnosed with any type of cancer.
  • They must not have any physical health conditions that would restrict their participation in an aerobic and resistance exercise program.
  • They must be willing to participate in two exercise classes per week at a gym space at the University of Calgary.
  • They must not be planning on moving for the next 12 months
  • Not currently meeting the Canadian Physical Activity Guidelines (150 minutes of aerobic activity per week and 2 sessions of resistance training per week) for the last three months.
  • Be able to speak and read English

Exclusion Criteria:

  • Providing care to a child with cancer Participants caring for a child with cancer will be excluded
  • Participants with a health condition that limits their participation in a physical activity program will be excluded
  • Participants who were previously caring for a cancer patient and that patient has now died (i.e. bereaved caregivers) will be excluded
  • Participants meeting the Canadian Physical Activity guidelines for the past three months will be excluded
  • Participants who cannot attend the group exercise classes will be excluded

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Exercise Group
One half of the participants enrolled in the 24 week center-based structured exercise and education program will be randomized to the immediate exercise group. The immediate exercise group will receive a 12 week center based structured exercise program followed by a 12 week maintenance of exercise program.
Behavioral: A 24 week center-based structured exercise and education program
The intervention will consist of a strength and aerobic exercise program. The exercise program will include twice weekly group resistance exercises classes, twice monthly group education classes, and individual activities to achieve 150 weekly minutes of aerobic activity. The resistance exercise and education classes will be run at a gym space at the University of Calgary. The wait-list control participants will be told not to change their activity levels throughout the 12 weeks of the trial. The wait list control participants will be enrolled into the exercise and education intervention once they have completed 12 weeks of wait-list control. A 12 week maintenance exercise program will be offered to all participants who finish the 12 week exercise and education program. The maintenance exercise program will consist of once weekly resistance group based exercise classes and individual activities to achieve 150 weekly minutes of aerobic physical activity.
No Intervention: Delayed Exercise Group
One half of the participants enrolled in the 24 week center-based structured exercise and education program will be randomized to the delayed exercise group. This will be a wait list control group and the participants will receive no active intervention for 12 weeks. The wait list control group will then be enrolled in the 12 week structured exercise intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 12 weeks
The physical functioning score of the Medical Outcomes Short Form 36 will be the primary outcome
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity levels
Time Frame: 12 weeks
Physical activity levels will be measured through standardized self-report questionnaires.
12 weeks

Collaborators and Investigators

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

Sponsor

University of Calgary

Collaborators

Canadian Institutes of Health Research (CIHR)

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

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14-2478

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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