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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)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
walking exercise
weight training
Usual Care
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, aerobic exercise, resistance training

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

aerobic exercise

resistence training

Usual Care

Arm Description

Subjects who are randomly assigned to this arm will be assigned a walking program to participate in 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

Subjects who are randomly assigned to this arm will not participate in any exercise program and will continue with usual care treatment

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2009
Last Updated
May 1, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00853164
Brief Title
A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)
Acronym
MAP-P
Official Title
A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, aerobic exercise, resistance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise
Arm Type
Experimental
Arm Description
Subjects who are randomly assigned to this arm will be assigned a walking program to participate in 3 times a week for eight weeks
Arm Title
resistence training
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Subjects who are randomly assigned to this arm will not participate in any exercise program and will continue with usual care treatment
Intervention Type
Behavioral
Intervention Name(s)
walking exercise
Intervention Description
Subjects will be given an exercise prescription for walking 3 times a week for eight weeks
Intervention Type
Behavioral
Intervention Name(s)
weight training
Intervention Description
participants will be given a weight training prescription to do 3 times a week for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Subjects in this arm will continue with their usual care and not start any exercise program for eight weeks.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Y Wolin, ScD
Organizational Affiliation
Washington University School of Medicine in Saint Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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