Feasibility Study of a Home-Based Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Castration-resistant Prostate Cancer
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Thirty patients will be enrolled, with the expectation that 20-25 will complete all follow-up measures.
Detailed Description
The purpose of this trial is to evaluate the feasibility and adherence to a home-based 12 week exercise intervention in mCRPC patients receiving ADT. It will also examine if a home-based exercise intervention can improve muscle strength, body composition, physical function, cardiopulmonary function fatigue, and patient reported outcomes (fatigue, depression, quality of life (QoL)).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of \< 50 ng/dL) receiving ADT. This will be verified by assessing total testosterone levels within 4 weeks prior to enrollment.
- •No current chemotherapy.
- •Patients may be receiving additional hormonal therapy agents including but not limited to antiandrogens (e.g. bicalutamide, enzalutamide) and CYP17 inhibitors (e.g. abiraterone).
- •Ability to engage safely in moderate exercise as determined by their treating physician.
- •Not previously engaged in regular exercise training (\<3 or more d/wk for \> 30 min/d or \<90 mins per week total including strength training, aerobic training, or walking) in the past 6 months.
- •Access to a computer or a smart phone for syncing and uploading wearable activity data.
- •Be able to speak and read English.
Exclusion Criteria
- •Any condition that causes severe pain with exertion.
- •History of bone fractures.
- •Active cardiovascular disease including any of the following:
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure .
- •History of myocardial infarction or unstable angina within 6 months prior to Day
- •History of stroke or transient ischemic attack within 6 months prior to Day
- •Acute or chronic respiratory disease that is severe enough to compromise the ability of the participant to safely engage in exercise training protocol.
- •Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise.
- •Neurological conditions that affect balance and, or muscle strength.
- •Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent.
Outcomes
Primary Outcomes
Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.
Time Frame: 12 weeks after baseline testing
To estimate the feasibility of a 12 week, home-based exercise intervention in metastatic castrate resistant prostate cancer (mCPRC) patients undergoing androgen deprivation therapy by reporting the percentage of patients who complete the pre/post testing following the intervention. This was calculated as the number of subjects who completed the trial compared to the total number who completed baseline testing.
Secondary Outcomes
- Patient Reported Outcomes: Depression(12 weeks after baseline testing)
- Lean Mass(12 weeks after baseline testing)
- Physical Function: 6m Walk(12 weeks after baseline testing)
- Muscle Quality(12 weeks after baseline testing)
- Chest Press Maximal Strength(12 weeks after baseline testing)
- Chest Press Muscle Endurance(12 weeks after baseline testing)
- Fat Mass(12 weeks after baseline testing)
- Physical Function: Timed Up and Go(12 weeks after baseline testing)
- Patient Reported Outcomes: Quality of Life(12 weeks after baseline testing)
- Muscle Size (Cross-sectional Area)(12 weeks after baseline testing)
- Leg Press Muscle Endurance(12 weeks after baseline testing)
- Adherence to the Intervention(12 weeks after baseline testing)
- Patient Reported Outcomes: Fatigue(12 weeks after baseline testing)
- Cardiopulmonary Function(12 weeks after baseline testing)
- Physical Function: Stair Climb(12 weeks after baseline testing)
- Physical Function: 400m Walk(12 weeks after baseline testing)
- Patient Reported Outcomes: Anxiety(12 weeks after baseline testing)
- Leg Press Maximal Strength(12 weeks after baseline testing)
- Percent Body Fat(12 weeks after baseline testing)