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

NCT ID: NCT00853164

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

walking exercise

Intervention Type: BEHAVIORAL

Subjects will be given an exercise prescription for walking 3 times a week for eight weeks

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

Group Type: EXPERIMENTAL

weight training

Intervention Type: BEHAVIORAL

participants will be given a weight training prescription to do 3 times a week for eight weeks.

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Subjects in this arm will continue with their usual care and not start any exercise program for eight weeks.

Interventions

walking exercise

Subjects will be given an exercise prescription for walking 3 times a week for eight weeks

Intervention Type: BEHAVIORAL

weight training

participants will be given a weight training prescription to do 3 times a week for eight weeks.

Intervention Type: BEHAVIORAL

Usual Care

Subjects in this arm will continue with their usual care and not start any exercise program for eight weeks.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Y Wolin, ScD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine in Saint Louis

Locations

Washington University School of medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

08-0318

Identifier Type: -

Identifier Source: org_study_id