Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer

NCT03397030 | Completed

• 1 other identifier: HSC20160604HU
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to demonstrate the impact of a home based exercise program versus wait-list control to modulate circulating prognostic biomarkers in men with prostate cancer under active surveillance.

Conditions

Prostatic Neoplasm

Keywords

Prostate Cancer; Biomarkers; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in concentration of circulating Prognostic Biomarkers

  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.

  Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit.

Secondary Outcomes (1)

• Fatigue Biomarker Index

  Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit.

Other Outcomes (2)

• Improvement in Physical Function

  Baseline and Week 24 visits.

• Improvement in Body Composition

  Baseline visit, Week 12 visit, Week 18 visit, and Week 24 visit.

Study Arms (2)

Home-Based Exercise Program

EXPERIMENTAL

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

Waitlist-Control Group

NO INTERVENTION

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.

Interventions

Home-Based Exercise Program OTHER

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.

Also known as: Exercise Group

Home-Based Exercise Program

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Participants are required to have prostate cancer under active surveillance.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 40 or older
• Ambulating male
• Diagnosed with low grade prostate cancer

You may not qualify if:

• prostatectomy
• severe cardiac disease (New York Heart Association class III or greater)
• angina
• severe osteoporosis
• uncontrolled hypertension (blood pressure \> 160/95mm Hg)
• uncontrolled sinus tachycardia (\> 120 beats per minute)
• uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (\> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness,
• severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, lower limb fractures within 6 months, lower limb amputation).

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (2)

South Texas Veterans Health Care

San Antonio, Texas, 78229, United States

Location

UT Health San Antonio School of Nursing

San Antonio, Texas, 78229, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Darpan Patel, PhD

  UT Health San Antonio School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was used in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed randomized controlled, 2 arm parallel group pilot study.

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 11, 2018
• Study Start: January 5, 2017
• Primary Completion: July 9, 2020
• Study Completion: November 19, 2020
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)