N/A
N=22
Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer
Castration-resistant Prostate Cancer · Androgen Deprivation Therapy
Bottom Line
View on ClinicalTrials.gov: NCT03672396 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing. — 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home-based exercise (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing. |
16 | — |
| SECONDARY Adherence to the Intervention |
80.1; 65.5; 72.8 | — |
| SECONDARY Physical Function: 6m Walk |
4.4; 4.5 | 0.378 |
| SECONDARY Physical Function: Timed Up and Go |
10.4; 10.8 | 0.586 |
| SECONDARY Physical Function: Stair Climb |
6.4; 6.2 | 0.252 |
| SECONDARY Physical Function: 400m Walk |
329.8; 313.5 | 0.111 |
| SECONDARY Patient Reported Outcomes: Fatigue |
39; 40 | 0.579 |
| SECONDARY Patient Reported Outcomes: Quality of Life |
119; 119 | 0.948 |
| SECONDARY Patient Reported Outcomes: Depression |
3; 3 | 0.594 |
| SECONDARY Patient Reported Outcomes: Anxiety |
4; 3 | 0.274 |
| SECONDARY Muscle Size (Cross-sectional Area) |
8.3; 10.2 | 0.013 sig |
| SECONDARY Muscle Quality |
110.2; 114.3 | 0.369 |
| SECONDARY Chest Press Maximal Strength |
62.4; 62.0 | 0.945 |
| SECONDARY Chest Press Muscle Endurance |
14.1; 15.4 | 0.420 |
| SECONDARY Leg Press Maximal Strength |
142.1; 141.5 | 0.941 |
| SECONDARY Leg Press Muscle Endurance |
11.8; 14.1 | 0.203 |
| SECONDARY Cardiopulmonary Function |
19.3; 20.1 | 0.057 |
| SECONDARY Lean Mass |
54.5; 51.4 | 0.809 |
| SECONDARY Fat Mass |
30; 28.4 | 0.191 |
| SECONDARY Percent Body Fat |
34.0; 34.3 | 0.237 |
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.
Eligibility Criteria
Inclusion Criteria
- Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of 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 1.
- History of stroke or transient ischemic attack within 6 months prior to Day 1.
- 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.
Data sourced from ClinicalTrials.gov (NCT03672396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.