Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorDana-Farber Cancer Institute
About this trial
The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem.
Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question.
Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease
Histologically diagnosed of localized or metastatic prostate cancer
Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone [LHRH] agonist/antagonist and/or androgen receptor [AR] agonist/antagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment
Disqualifiers
Are not receiving ADT (i.e., LHRH agonist/antagonist and/or AR agonist/antagonist)
Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise
Are not English or Spanish speaking
Patients with secondary diagnosis (with the exception of basal cell carcinoma)
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic and resistance exercise
Other interventionPerform exercise at home with virtual supervision, including aerobic exercise (e.g.,cycling), which can improve cardiovascular (heart) and lung function, and resistance exercise (e.g., dumbbell lifting and using resistance band. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer
Usual Care
Other interventionMaintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise (aerobic and resistance exercise) program after 16 weeks.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Aerobic and resistance exerciseExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cardiovascular disease risk factors
Framingham Risk Score, an established comprehensive tool for evaluating the risk of developing cardiovascular disease using blood samples (i.e., low-density lipoprotein-cholesterol \[LDL-C\] or total cholesterol \[TC\], high-density lipoprotein-cholesterol \[HDL-C\]), demographic and medical profiles , and lifestyle behaviors (i.e., age, blood pressure, and diabetic and smoking status). The score ranges from -4 to 36 and the 10-year cardiovascular risk will be calculated accordingly (a higher score indicates a higher risk of cardiovascular disease).
Time frame
baseline to 4 monthsSecondary outcomes
1
Cardiorespiratory capacity
Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 15-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms
Time frame
baseline to 4 months2
Muscular strength
Muscular strength will be measured as 1-repetition maximum (RM) (i.e., the greatest resistance that can be moved through the full range of motion), which has been the standard for strength assessments. 1-RM values will be estimated from 10-RM using validated equations on 12 exercises including the ten exercises utilized in the prescription not performed on machines.
Time frame
baseline to 4 months3
Short Physical Performance Battery (SPPB)
Physical function will be assessed by the SPPB. This includes the following 3 lower extremity measures completed in the following order. Timed balance (seconds): Balance will be assessed under 3 conditions (side-by-side, semi-tandem, and tandem stands). Gait speed (seconds): Gait speed will be assessed over a 4-meter flat surface distance. The participant will be asked to complete 2 attempts of this test. Time will be recorded using an electronic timing system. Chair stand (seconds): Chair stand will be performed under 2 conditions: a) subjects will perform a single chair stand; b) subjects will be asked to perform 5 repeated chair stands as quickly as possible; time to completion will be recorded.
Time frame
baseline to 4 months4
Timed-Up-and-Go (TUG)
Mobility will be assessed using the Timed Up and Go (TUG) test, which has been shown to predict immediate fall risk better than static balance tests or isometric muscle strength. Participants begin seated in a chair with hands on the armrests, are asked to rise, walk to a line on the floor 3 m from the chair, turn around, and return to the same seated position as quickly and safe as possible. Scores will be taken as the time (seconds) to complete the task, with one practice trial given. An average of time for 3 trials is calculated.
Time frame
baseline to 4 monthsSponsors and contacts
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Source ClinicalTrials.gov