Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03397030|
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : January 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasm||Other: Home-Based Exercise Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study is designed randomized controlled, 2 arm parallel group pilot study.|
|Masking:||None (Open Label)|
|Masking Description:||No masking was used in this study.|
|Official Title:||Impact of a Home-based Exercise Program on Prognostic Biomarkers in Men With Prostate Cancer|
|Actual Study Start Date :||January 5, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Home-Based Exercise Program
Participants will complete a prescribed home-based exercise program and will follow up with research staff at the UT Health San Antonio School of Nursing.
Other: Home-Based Exercise Program
The intervention will include a combination of both aerobic and body-weight based exercises. The aerobic portion of the intervention will include 5 days of light to moderate intensity walking for 30 mins. Intensity will be set at 40-60% of the individual's heart rate reserve. The body-weight based exercises will be done 3 times a week and will consist of 3 sets of 15 reps of bodyweight squats, incline push-ups, and hip thrusts. If these exercises cannot be performed, lower intensity exercises such as sit-to-stand, wall push up and pelvic tilt can be replaced. Individuals in this group will be given a pocket guide with instructions on how to safely perform the exercises and document their completion.
Other Name: Exercise Group
No Intervention: Waitlist-Control Group
Participants assigned to this group will be asked to maintain normal activity and visit the UT Health San Antonio School of Nursing for research appointments.
- Change in concentration of circulating Prognostic Biomarkers [ Time Frame: Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit. ]Analyze concentrations of Prostate-specific antigen (PSA), Prostate-specific membrane antigen (PSMA), Early prostate cancer antigen (EPCA), Urokinase plasminogen activator (uPA), and Urokinase plasminogen activator receptor (uPAR) in serum collected at each visit with research staff.
- Fatigue Biomarker Index [ Time Frame: Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit. ]Analyze a novel salivary biomarker for fatigue: Measurement of the salivary biomarker, the Fatigue Biomarker Index, will be measuring the concentration of each of two peptides, GGHPPPP (SEQ ID NO:1) and ESPSLIA (SEQ ID NO:2), in a saliva sample taken from the subject then calculating the ratio of the concentration of GGHPPPP (SEQ ID NO:1) to the concentration of ESPSLIA (SEQ ID NO:2) measured according to the equation: Fatigue biomarker index (FBI)=[GGHPPPP]/[ESPSLIA]
- Improvement in Physical Function [ Time Frame: Baseline and Week 24 visits. ]A 6-minute walk will be will be completed by participants during their initial and last appointments with research staff.
- Improvement in Body Composition [ Time Frame: Baseline visit, Week 12 visit, Week 18 visit, and Week 24 visit. ]Changes in participant's body composition will be measured at each visit with research staff.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397030
|Contact: Darpan Patel, PhDemail@example.com|
|United States, Texas|
|UT Health San Antonio School of Nursing||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Darpan Patel, PhD 210-567-0362 firstname.lastname@example.org|
|Principal Investigator: Darpan I Patel, PhD|
|Principal Investigator:||Darpan Patel, PhD||UT Health San Antonio School of Nursing|