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Completed

NCT Number: NCT01709175

Strength Training Study for Survivors of Breast and Gynecologic Cancer

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Behavior Breast Diseases Breast Neoplasms Cervical Cancer Endocrine Gland Neoplasms Endocrine System Diseases Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Gynecologic Cancer Motor Activity Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Exercise Lab: Queen Elizabeth II Dickson Centre

Halifax, Nova Scotia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

strength training

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Dalhousie University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2012
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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