Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kerri Winters, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00954044
First received: August 5, 2009
Last updated: April 10, 2014
Last verified: April 2014
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses

Resource links provided by NLM:


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 ]

Enrollment: 128
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercising Together
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.

Placebo Comparator: Usual Care
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

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

Publications:
Responsible Party: Kerri Winters, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00954044     History of Changes
Other Study ID Numbers: 5366
Study First Received: August 5, 2009
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
randomized clinical trial
prostate cancer
partnered exercise

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014