Strength Training Study for Survivors of Breast and Gynecologic Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709175
• Other study ID #: JB-007
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: June 4, 2015
• Start date: November 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Gynecologic Cancer
• Ovarian Cancer
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Behavioral:
• Strength Training
This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.

Locations

Country	Name	City	State
Canada	Exercise Lab: Queen Elizabeth II Dickson Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Dalhousie University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)	No
Secondary	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)	Final (end of week 13)	Yes
Secondary	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.	Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)	No
Secondary	Changes in Body Composition	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)	No
Secondary	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.	Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)	No
Secondary	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	Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13)	No
Secondary	Changes in Physical Activity Levels	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)	No