A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT) (MAP-P)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Behavioral: walking exercise Behavioral: weight training Behavioral: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy |
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: aerobic exercise
Subjects who are randomly assigned to this arm will be assigned a walking program to participate in 3 times a week for eight weeks
|
Behavioral: walking exercise
Subjects will be given an exercise prescription for walking 3 times a week for eight weeks
|
|
Experimental: resistence training
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
|
Behavioral: weight training
participants will be given a weight training prescription to do 3 times a week for eight weeks.
|
|
Active Comparator: Usual Care
Subjects who are randomly assigned to this arm will not participate in any exercise program and will continue with usual care treatment
|
Behavioral: Usual Care
Subjects in this arm will continue with their usual care and not start any exercise program for eight weeks.
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Missouri | |
| Washington University School of medicine | |
| Saint Louis, Missouri, United States, 63108 | |
| Principal Investigator: | Kathleen Y Wolin, ScD | Washington University School of Medicine in Saint Louis |
More Information
No publications provided
| Responsible Party: | Kathleen Wolin ScD Principal Investigator, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00853164 History of Changes |
| Other Study ID Numbers: | 08-0318 |
| Study First Received: | February 27, 2009 |
| Last Updated: | November 17, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
prostate cancer aerobic exercise resistance training |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013