Exercise for Physical Health in Men With Prostate Cancer

NCT00660686 | Completed DMC

• 1 other identifier: 387
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength and impact exercise training to flexibility/relaxation training on body composition (bone, muscle and fat mass), physical function (strength, gait, power, balance and self-report physical function and symptoms) in men currently treated with hormone therapy for prostate cancer.

Conditions

Prostatic Neoplasm; Osteoporosis

Keywords

randomized clinical trial; elderly; cancer survivor; bone health; body composition; signs and symptoms; Androgen Deprivation Therapy

Outcome Measures

Primary Outcomes (1)

• bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass.

  12 months

Secondary Outcomes (1)

• maximal muscle strength, gait, balance, self-report physical function, symptoms

  12 months

Study Arms (2)

1

EXPERIMENTAL

Progressive resistance training program 3 times a week for 12 months

Behavioral: Resistance Exercise

2

ACTIVE COMPARATOR

Seated flexibility training 3 times a week for 12 months

Behavioral: Flexibility Training

Interventions

Resistance Exercise BEHAVIORAL

60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months

Also known as: Arm 1: N/A

1

Flexibility Training BEHAVIORAL

60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.

Also known as: Arm 2: N/A

2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed prostate cancer
• presently receiving or planning to begin androgen deprivation therapy for prostate cancer

You may not qualify if:

• Presence of bone metastases in the proximal femur and lumbar spine
• Clinically defined osteoporosis
• Current or previous use of medications known to affect bone metabolism
• Current regular participation (\>2x/wk for at least 30 min/session) in a planned session of moderate-vigorous impact or resistance training
• A medical condition, disorder, or medication that contraindicates participation in moderate intensity impact or resistance exercise

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Lance Armstrong Foundation: collaborator

Study Sites (1)

OHSU School of Nursing

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

  PMID: 39606939 DERIVED

• Winters-Stone KM, Dobek JC, Bennett JA, Dieckmann NF, Maddalozzo GF, Ryan CW, Beer TM. Resistance training reduces disability in prostate cancer survivors on androgen deprivation therapy: evidence from a randomized controlled trial. Arch Phys Med Rehabil. 2015 Jan;96(1):7-14. doi: 10.1016/j.apmr.2014.08.010. Epub 2014 Sep 3.

  PMID: 25194450 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Osteoporosis; Signs and Symptoms

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; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Signs and Symptoms

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

• Kerri M Winters, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 17, 2008
• Study Start: January 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

US (1)