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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

February 27, 2009
November 17, 2009
July 2008
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00853164 on ClinicalTrials.gov Archive Site
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A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)
A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy

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.

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Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Behavioral: walking exercise
    Subjects will be given an exercise prescription for walking 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.
  • Behavioral: Usual Care
    Subjects in this arm will continue with their usual care and not start any exercise program for eight weeks.
  • 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
    Intervention: Behavioral: walking exercise
  • 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
    Intervention: Behavioral: weight training
  • 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
    Intervention: Behavioral: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Male
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00853164
08-0318
No
Kathleen Wolin ScD Principal Investigator, Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Kathleen Y Wolin, ScD Washington University School of Medicine in Saint Louis
Washington University School of Medicine
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP