Strength Training Study for Survivors of Breast and Gynecologic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Capital District Health Authority, Canada
Sponsor:
Collaborator:
Dalhousie University
Information provided by (Responsible Party):
Scott Grandy, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01709175
First received: October 9, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Gynecologic Cancer
Ovarian Cancer
Uterine Cancer
Cervical Cancer
Behavioral: Strength Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Effect of Resistance Exercise Frequency in Breast and Gynecologic Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Changes in Muscular Strength [ Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Final (end of week 13) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) ] [ Designated as safety issue: No ]
    Body composition will be assessed using bioelectric impedance to determine percent body fat, lean body mass, and fat mass.

  • Changes in Quality of Life [ Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) ] [ Designated as safety issue: No ]
    Physical activity will be estimated using the Godin Leisure Time Exercise Questionnaire.


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Resistance Exercise
  • Weight Training
  • Body Building
  • Exercise
  • Physical Activity
  • 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:
  • Resistance Exercise
  • Weight Training
  • Body Building
  • Exercise
  • Physical Activity
  • Restive Exercise

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709175

Contacts
Contact: Tim D Gravelle, MSc (candidate) (902) 209-3983 Tim.Gravelle@dal.ca
Contact: Melanie Keats, Ph D (902) 494-7173 melanie.keats@dal.ca

Locations
Canada, Nova Scotia
Exercise Lab: Queen Elizabeth II Dickson Centre Recruiting
Halifax, Nova Scotia, Canada
Sub-Investigator: Tim D Gravelle, MSc (candidate)         
Sponsors and Collaborators
Capital District Health Authority, Canada
Dalhousie University
Investigators
Principal Investigator: Scott Grandy, Ph D CDHA
  More Information

No publications provided

Responsible Party: Scott Grandy, Principle Investigator, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01709175     History of Changes
Other Study ID Numbers: JB-007
Study First Received: October 9, 2012
Last Updated: November 27, 2012
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Cancer
Breast Cancer
Gynecologic Cancer
Strength Training
Exercise
Physical Activity
Fatigue
Quality of Life
Strength
Fitness
Cancer Survivor
Survivor

Additional relevant MeSH terms:
Uterine Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Breast Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014