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Preventing a Decline in Physical Function in Older Androgen-Deprived Men with Structured Exercise Training (RESIST-ADT Trial)

Enrolling

Trial ID:NCT04485767

View complete trial on ClinicalTrials.gov

Protocol #:20-193

877-DF-TRIAL (877-338-7425)

Condition(s):Physical Function, Prostate Cancer

Phase:II

Principal Investigator:Basaria, Shehzad

Trial Description:
The overall goal of this study is to determine if implementing structured exercises prevent decline in muscle mass, muscle strength and physical function in men with prostate cancer undergoing androgen deprivation therapy (ADT). Our main hypothesis is that structured resistance exercise training in men undergoing ADT will preserve physical function assessed by loaded stair climbing power compared with the control group. The trial will also examine the efficacy of the exercise regimen on muscle strength, QOL and fatigue. The findings of this trial will lay the groundwork for definitive intervention trials to prevent frailty and falls in these men.

Eligibility Requirements:
- Men with active Prostate Cancer who are 60 years or older.
- Hormone-naive men about to undergo medical or surgical ADT.
- Planned ADT for at least 6 months.
- Life expectancy of at least 6 months from enrollment.
- Ability and willingness to provide informed consent.
Exclusion Criteria:
- Active medical conditions affecting participation in exercise training (limiting arthropathies, myopathies, severe peripheral vascular disease, or severe neuropathy).
- Cardiovascular disease (current angina, severe valvular disease, advanced congestive heart failure, arrhythmias, or stroke with residual muscular weakness).
- Prior hip or knee replacement.
- History of lower extremity fracture in the past 6 months.

Protocol #: 20-193

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)