Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses

April 10, 2014 updated by: Kerri Winters, Oregon Health and Science University
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercising Together
Partnered progressive resistance exercise

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.

Couples will continue doing their usual daily activities for 6 months
Placebo Comparator: Usual Care
Usual Care Control

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.

Couples will continue doing their usual daily activities for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical function
Time Frame: baseline, 3, 6 months
baseline, 3, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Marital quality
Time Frame: 0,3,6 months
0,3,6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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