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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00954044
Other study ID # 5366
Secondary ID
Status Completed
Phase N/A
First received August 5, 2009
Last updated April 10, 2014
Start date January 2010
Est. completion date June 2011

Study information

Verified date April 2014
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date June 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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.
Randomized Exercise Intervention
Couples will continue doing their usual daily activities for 6 months

Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physical function baseline, 3, 6 months No
Secondary Marital quality 0,3,6 months No
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