This trial is active, not recruiting.

Condition prostate cancer
Treatments walking exercise, weight training, usual care
Sponsor Washington University School of Medicine
Start date July 2008
End date May 2010
Trial size 60 participants
Trial identifier NCT00853164, 08-0318


60 eligible subjects will be randomized into one of three study arms 1) aerobic exercise, 2) resistance exercise, or 3) usual care. Baseline measurements will be done on all study subjects, these measurements include: height, weight, dual energy x-ray absorptiometry (DXA) for bone mineral density and lean body mass measurements, blood will be taken to measure serum free testosterone, prostate-specific antigen (PSA), glucose, and insulin levels. Fitness will also be evaluated using a graded exercise test. Questionnaires on health and personal history will also be completed. Men randomized to the aerobic exercise treatment arm will participate in a walking program three times a week for eight weeks. The participants will start at 15 minutes per session and increase to a goal of 60 minutes per session. Men randomized to the resistance training treatment arm will participate in an eight-week program of eight strength training exercises three times per week. Men in the usual care arm will receive written materials from the American Cancer Society about coping with cancer, which includes information about participation in physical activity. At the end of the eight week intervention participants in all three study arms will complete the same questionnaires and measurements they completed at baseline.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Subjects who are randomly assigned to this arm will be assigned a walking program to participate in 3 times a week for eight weeks
walking exercise
Subjects will be given an exercise prescription for walking 3 times a week for eight weeks
Subjects who are randomly assigned to this arm will be assigned a weight training program to participate in 3 times a week for eight weeks
weight training
participants will be given a weight training prescription to do 3 times a week for eight weeks.
(Active Comparator)
Subjects who are randomly assigned to this arm will not participate in any exercise program and will continue with usual care treatment
usual care
Subjects in this arm will continue with their usual care and not start any exercise program for eight weeks.

Primary Outcomes

Feasibility of recruiting 60 men with prostate CA on ADT to an ex intervention study w/ three arms. To determine if an ex prgm provides symptom mgt as compared to usual care,if resistance training provides symptom mgt not obtained from aerobic ex alone.
time frame: 8 weeks

Eligibility Criteria

Male participants from 40 years up to 80 years old.

Inclusion Criteria: - Men with metastatic prostate cancer receiving ADT and men who have failed primary therapy and are receiving ADT. - Men from the radiology practice who are receiving ADT as neoadjuvant therapy to primary radiotherapy (enrolled only following completion of primary radiotherapy). Exclusion Criteria: - Men with the following counter-indications to exercise: - Lower limb, bone, muscle, or joint pathology of a severity which limits their ability to be physically active. - A history of significant cardiac disease using criteria established by the American College of Sports Medicine ( Criteria: pain, discomfort in the chest, neck, jaw, arms, or other areas that may be due to ischemia; shortness of breath at rest or with mild exertion; ankle edema; palpitations or tachycardia; known heart murmur; unusual fatigue or shortness of breath with usual activities' syncope) - Other medical contraindications which would compromise participation in a lifestyle physical activity program. - Those who are currently physically active

Additional Information

Official title A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy
Principal investigator Kathleen Y Wolin, ScD
Trial information was received from ClinicalTrials.gov and was last updated in November 2009.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.