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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014