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

NCT00853164 | Completed

• 1 other identifier: 08-0318
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

prostate cancer; aerobic exercise; resistance training

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (3)

aerobic exercise

EXPERIMENTAL

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

resistence training

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

walking exercise BEHAVIORAL

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

aerobic exercise

weight training BEHAVIORAL

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

resistence training

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of medicine

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kathleen Y Wolin, ScD

  Washington University School of Medicine in Saint Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: July 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)