Renewing Caregiver Health and Well-being Through Exercise

Family Caregivers Clinical Trial

— RECHARGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580461
• Other study ID #: 14-2478
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: October 24, 2016
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Family Caregivers

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary Health and Wellness Lab	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	The physical functioning score of the Medical Outcomes Short Form 36 will be the primary outcome	12 weeks	No
Secondary	Physical activity levels	Physical activity levels will be measured through standardized self-report questionnaires.	12 weeks	No

External Links

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