search
Back to results

Strength Training Study for Survivors of Breast and Gynecologic Cancer

Primary Purpose

Breast Cancer, Gynecologic Cancer, Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Strength Training
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Cancer, Breast Cancer, Gynecologic Cancer, Strength Training, Exercise, Physical Activity, Fatigue, Quality of Life, Strength, Fitness, Cancer Survivor, Survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Exercise Lab: Queen Elizabeth II Dickson Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Once-a-week Strength Training

Twice-a-week Strength Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in Muscular Strength
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.

Secondary Outcome Measures

Process Measures
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)
Changes in Muscular Endurance
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.
Changes in Body Composition
Body composition will be assessed using bioelectric impedance to determine percent body fat, lean body mass, and fat mass.
Changes in Quality of Life
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.
Changes in Fatigue
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
Changes in Physical Activity Levels
Physical activity will be estimated using the Godin Leisure Time Exercise Questionnaire.

Full Information

First Posted
October 9, 2012
Last Updated
June 4, 2015
Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University
search

1. Study Identification

Unique Protocol Identification Number
NCT01709175
Brief Title
Strength Training Study for Survivors of Breast and Gynecologic Cancer
Official Title
The Effect of Resistance Exercise Frequency in Breast and Gynecologic Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Gynecologic Cancer, Ovarian Cancer, Uterine Cancer, Cervical Cancer
Keywords
Cancer, Breast Cancer, Gynecologic Cancer, Strength Training, Exercise, Physical Activity, Fatigue, Quality of Life, Strength, Fitness, Cancer Survivor, Survivor

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Once-a-week Strength Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Twice-a-week Strength Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strength Training
Other Intervention Name(s)
Resistance Exercise, Weight Training, Body Building, Exercise, Physical Activity, Restive Exercise
Intervention Description
This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.
Primary Outcome Measure Information:
Title
Changes in Muscular Strength
Description
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.
Time Frame
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Secondary Outcome Measure Information:
Title
Process Measures
Description
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)
Time Frame
Final (end of week 13)
Title
Changes in Muscular Endurance
Description
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.
Time Frame
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Title
Changes in Body Composition
Description
Body composition will be assessed using bioelectric impedance to determine percent body fat, lean body mass, and fat mass.
Time Frame
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Title
Changes in Quality of Life
Description
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.
Time Frame
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Title
Changes in Fatigue
Description
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
Time Frame
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)
Title
Changes in Physical Activity Levels
Description
Physical activity will be estimated using the Godin Leisure Time Exercise Questionnaire.
Time Frame
Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Grandy, Ph D
Organizational Affiliation
CDHA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Lab: Queen Elizabeth II Dickson Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Strength Training Study for Survivors of Breast and Gynecologic Cancer

We'll reach out to this number within 24 hrs