NCT02580461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

October 16, 2015

Last Update Submit

October 24, 2016

Conditions

Keywords

family caregiverscancerexercise interventioncenter based

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    The physical functioning score of the Medical Outcomes Short Form 36 will be the primary outcome

    12 weeks

Secondary Outcomes (1)

  • Physical activity levels

    12 weeks

Study Arms (2)

Immediate Exercise Group

EXPERIMENTAL

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

Delayed Exercise Group

NO INTERVENTION

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.

Interventions

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.

Immediate Exercise Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary Health and Wellness Lab

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Nicole Culos-Reed, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Faculty of Kinesiology,

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 20, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations