Strength Training Study for Survivors of Breast and Gynecologic Cancer

June 4, 2015 updated by: Scott Grandy, Nova Scotia Health Authority

The Effect of Resistance Exercise Frequency in Breast and Gynecologic Cancer Survivors

The purpose of this study is to compare once-a-week vs. twice-a-week strength training in survivors of breast and gynecologic cancer to determine which is the optimal exercise prescription.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As a result of cancer and its treatment, survivors of breast and gynecologic cancer are reported to have deficits in both physical and psycho-social health. In cancer survivors exercise has been shown to improve fitness, increase bone density and lean body mass, enhance self-esteem, and reduce fatigue. These changes have a positive effect on the survivor's physical functioning and quality of life. However, there are few studies which have examined the effects of strength training or studies aimed at determining optimal exercise prescription in this population. Therefore, the purpose of this study is to compare two strength training prescriptions (once-a-week vs. twice-a-week strength training) to determine which prescription (if any) results in greater benefit for survivors. It is hoped that the results of this study will lead to a better understanding of how strength training improves the health of survivors and will help inform future exercise guidelines for this population.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • 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
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Exercise Lab: Queen Elizabeth II Dickson Centre

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female Survivor of Breast or Gynecologic Cancer
  • Completed Primary Treatment (hormone treatments are ok)
  • 18 years of age or older
  • Physician's Permission to Participate

Exclusion Criteria:

  • High Risk Individuals (determined by questionnaire)
  • Secondary Health Problems that could increase the risk of participating (Includes but not limited to: Uncontrolled angina/hypertension, heart failure, osteoporosis, brain metastases, history of seizures).
  • Report participating in a strength training program in the past six (6) months
  • Have had a change in medication in the past 30 days

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Once-a-week Strength Training
After completing the introduction to strength training (two sessions in the first week), participants randomized to the once-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet ONCE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises.
Behavioral: Strength Training
This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.
Other Names:
  • Exercise
  • Physical Activity
  • Resistance Exercise
  • Weight Training
  • Body Building
  • Restive Exercise
Experimental: Twice-a-week Strength Training
After completing the introduction to strength training (two sessions in the first week), participants randomized to the twice-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet TWICE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises.
Behavioral: Strength Training
This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.
Other Names:
  • Exercise
  • Physical Activity
  • Resistance Exercise
  • Weight Training
  • Body Building
  • Restive Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Muscular Strength
Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Muscular Strength will be assessed using the predicted one-repetition maximum method (Brzycki method)using the bench press and leg press to measure upper and lower body strength.
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Process Measures
Time Frame: Final (end of week 13)
Process measures will provide insight about the feasibility of the exercise prescriptions. Included measures are: recruitment (percent of interested survivors who consent); adherence (the number of sessions attended); compliance (the degree to which the survivors follow the exercise prescription); and safety (all adverse events will be recorded)
Final (end of week 13)
Changes in Muscular Endurance
Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Muscular Endurance will be assessed using the standard load test. Participants will lift a weight equal to 50% one repetition maximum as many times as possible. The bench press and leg press will be used to measure endurance of the upper and lower body.
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Body Composition
Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Body composition will be assessed using bioelectric impedance to determine percent body fat, lean body mass, and fat mass.
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Quality of Life
Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Quality of Life will be assessed using the Medical Outcomes Survey - Short Form. This survey measures multiple aspects of quality of life including: physical function, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, and mental health.
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Fatigue
Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Fatigue will me measured using the Fatigue scale of the Functional Assessment of Cancer Treatment. This is a 13 item questionnaire that measures the degree to which a cancer survivor experiences fatigue
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Changes in Physical Activity Levels
Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Physical activity will be estimated using the Godin Leisure Time Exercise Questionnaire.
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Collaborators

Dalhousie University

Investigators

  • Principal Investigator: Scott Grandy, Ph D, CDHA

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

November 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 18, 2012

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JB-007

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.

Clinical Trials on Cervical Cancer

Clinical Trials on Strength Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe