- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00954044
Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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
General Publications
- Winters-Stone KM, Lyons KS, Bennett JA, Beer TM. Patterns and predictors of symptom incongruence in older couples coping with prostate cancer. Support Care Cancer. 2014 May;22(5):1341-8. doi: 10.1007/s00520-013-2092-0. Epub 2013 Dec 17.
- Winters-Stone KM, Lyons KS, Dobek J, Dieckmann NF, Bennett JA, Nail L, Beer TM. Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the Exercising Together project. J Cancer Surviv. 2016 Aug;10(4):633-44. doi: 10.1007/s11764-015-0509-0. Epub 2015 Dec 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5366
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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