Clinical trial NCT02580461: Renewing Caregiver Health and Well-being Through Exercise
Official title: Renewing Caregiver Health and Well-being Through Exercise: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Caregivers
Keywords: family caregivers
cancer
exercise intervention
center based
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-10-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical activity levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Health and Wellness Lab
state: Alberta
Study officials:
affiliation: University of Calgary
name: Nicole Culos-Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuthbert CA, King-Shier KM, Ruether JD, Tapp DM, Wytsma-Fisher K, Fung TS, Culos-Reed SN. The Effects of Exercise on Physical and Psychological Outcomes in Cancer Caregivers: Results From the RECHARGE Randomized Controlled Trial. Ann Behav Med. 2018 Jul 13;52(8):645-661. doi: 10.1093/abm/kax040.
citation: Cuthbert CA, King-Shier K, Tapp DM, Ruether D, Jackson C, Culos-Reed SN. Renewing caregiver health and wellbeing through exercise (RECHARGE): A randomized controlled trial. Contemp Clin Trials. 2016 Sep;50:273-83. doi: 10.1016/j.cct.2016.08.007. Epub 2016 Aug 13.