A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT) (MAP-P)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00853164
First received: February 27, 2009
Last updated: November 17, 2009
Last verified: November 2009
  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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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
Criteria

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
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: NCT00853164

Locations
United States, Missouri
Washington University School of medicine
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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 September 18, 2014