The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT). The names of the study intervention involved in this study is: • Supervised circuit training (aerobic and resistance exercise regimen)
This research study is a pilot, randomized control study, which is the first-time investigators are examining this intervention in this setting. Participants will be randomized into one of two study groups: Exercise Group versus Attention Control Group. Randomization means a participant is placed into a group by chance. The research study procedures include screening for eligibility, study treatment, including extensive evaluations of fitness, physical health and strength, blood tests, muscle biopsy, surveys, and follow-up visits. Participation in this research study is expected to last about 16 weeks. It is expected that about 80 people will take part in this research study. The Prostate Cancer Foundation is providing funding for this research study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
16-week, multicomponent exercise intervention comprised of sessions supervised by certified exercise oncology trainer and home-based, self-directed aerobic exercises. Stationary bike and accelerometer (activity/heart rate monitor) will be provided.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
NOT_YET_RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
NOT_YET_RECRUITINGChange in Circulating Inflammation for Exercise Group
Assessed by change in systemic inflammatory biomarkers through blood analysis (ul/ml).
Time frame: Baseline (week 0) and Post-intervention (week 17)
Frailty
This will be assessed by the Fried Frailty Phenotype, which measures participant ratings on a five-characteristic scale and will be totaled for an overall frailty score of 1-2, identified as prefail, or ≥3, identified as frail. Participants will receive a score of 1 (experience characteristic) or 0 (do not experience) for each characteristic.
Time frame: Baseline (week 0) and Post-intervention (week 17)
Sarcopenia
A sarcopenia score of ≤10.75 kg/m2, as assessed by computed tomography (CT), will be the cut point used for identifying muscle loss = 1 point.
Time frame: Baseline (week 0) and Post-intervention (week 17)
Skeletal Muscle Biomarkers - myokines
Assessed from muscle biopsy specimens of the vastus lateralis (ul/ml).
Time frame: Baseline (week 0) and Post-intervention (week 17)
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