Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses

This study is not yet open for participant recruitment.

Verified by Oregon Health and Science University, August 2009

First Received: August 5, 2009 No Changes Posted

Sponsored by:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00954044

Purpose

The purpose of this study is to explore the benefits of "Exercising Together"-a partnered strength training program for married couples coping with prostate cancer- on the physical and emotional health of prostate cancer survivors and their spouse and on marital quality.

Condition	Intervention
Prostate Cancer	Behavioral: Randomized Exercise Intervention

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses

Resource links provided by NLM:

MedlinePlus related topics: Cancer Exercise and Physical Fitness Prostate Cancer

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Physical function [ Time Frame: baseline, 3, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Marital quality [ Time Frame: 0,3,6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	124
Study Start Date:	January 2010
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Exercising Together: Experimental Partnered progressive resistance exercise	Behavioral: Randomized Exercise Intervention The Exercising Together training group will participate in 6 months of supervised, progressive partnered resistance exercise. Couples will participate in 2 exercise sessions a week for 6 months.
Usual Care: Placebo Comparator Usual Care Control	Behavioral: Randomized Exercise Intervention Couples will continue doing their usual daily activities for 6 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria For PCS:

Received treatment for histologically confirmed prostate cancer
Not currently undergoing radiation therapy or chemotherapy for prostate cancer
Currently residing with an identifiable spouse willing to participate
60 years and older at enrollment

Inclusion Criteria for Spouses:

Currently residing with prostate cancer survivor

Exclusion Criteria for prostate cancer survivor and Spouses:

Current participation in moderate/vigorous intensity resistance training 2 or more hours per week
Cognitive difficulties that preclude answering the survey questions, participating in performance tests, or giving informed consent
Medical condition, movement or neurological disorder, or medication that contraindicates participation in resistance exercise
Unwillingness to be randomized

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954044

Contacts

Contact: Kerri Winters-Stone, PhD	503-494-0813	wintersk@ohsu.edu
Contact: Jessica C Dobek, MS	503-494-4427	carmonaj@ohsu.edu

Locations

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:	Kerri Winters-Stone, PhD	Oregon Health & Science University-School of Nursing
Study Director:	Jessica Dobek, MS	Oregon Health & Science University-School of Nursing

More Information

No publications provided

Responsible Party:	Oregon Health & Science University-School of Nursing ( Dr. Kerri Winters-Stone, Prinicpal Invesigator )
Study ID Numbers:	5366
Study First Received:	August 5, 2009
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00954044 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

randomized clinical trial
prostate cancer
partnered exercise

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009