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

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.

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

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.
80

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

  • 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

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

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

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: 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

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
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

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
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

Sponsor

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

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.
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

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.
June 1, 2015

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.
May 1, 2016

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.
May 1, 2016

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 16, 2015

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 19, 2015

First Posted (Estimate)

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 20, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
October 26, 2016

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.
October 24, 2016

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.
October 1, 2016

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.
  • 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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