Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer
Purpose
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.
Condition
- Prostatic Neoplasm
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Men aged 40 or older
- Ambulating male
- Diagnosed with low grade prostate cancer
- Subjects willing and able to provide consent to participating in the study Exclusion
Criteria
- 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).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This study is designed randomized controlled, 2 arm parallel group pilot study.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- No masking was used in this study.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center at San Antonio
Study Contact
Detailed Description
Prostate cancer (PCa) is the most common non-skin cancer effecting American males. Several reports suggest that physical activity after cancer diagnosis is associated with better cancer- specific and overall survival in individuals diagnosed with PCa. There is a growing body of evidence for lifestyle interventions that aim to promote physical activity as having the potential to counter some of the adverse effects of cancer treatments, disease progression and other health outcomes. Exercise performed 2-3 times a week has been shown to improve physical fitness, functional performance, and quality of life in men with PCa; however, few men with PCa exercise regularly and do not meet national physical activity guidelines. A potential explanation on the lack of exercise in men with PCa is the absence of a structured, home-based, exercise program. While studies have shown positive effects of exercise in men with PCa, little is known about how physical activity effects tumor physiology in men with PCa. The primary objective of this pilot study is to gather preliminary data regarding the impact of a novel, home-based exercise program on PCa biomarkers associated with recurrence and metastasis of PCa in men under active surveillance.