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Renewing Caregiver Health and Well-being Through Exercise

NCT ID: NCT02580461

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Family Caregivers

Keywords

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family caregivers cancer exercise intervention center based

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

A 24 week center-based structured exercise and education program

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nicole Culos-Reed

Professor, Faculty of Kinesiology,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicole Culos-Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary Health and Wellness Lab

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 30010704 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27530087 (View on PubMed)

Related Links

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http://www.ucalgary.ca/healthandwellnesslab/

Related Info

Other Identifiers

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14-2478

Identifier Type: -

Identifier Source: org_study_id