Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Location contact
Christina Dieli-Conwright, PhD
PRINCIPAL_INVESTIGATOR
Christina Dieli-Conwright, PhD, MPH
CONTACT
PhD, MPH
CONTACT
NCT Number: NCT05327465
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Christina Dieli-Conwright, PhD
PRINCIPAL_INVESTIGATOR
Christina Dieli-Conwright, PhD, MPH
CONTACT
PhD, MPH
CONTACT
The research study procedures include: screening for eligibility, study intervention, and evaluation of blood markers (blood draw), body composition, cardiorespiratory fitness, muscular strength, and surveys at study entry and follow-up visit.
Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.
All participants will undergo two testing visits throughout the 16-weeks of the study period, with the exercise group part-taking in 1 additional testing visit at week 8 to assess aerobic fitness and muscular strength only.
Participants will be on the research study for 4 months. It is expected that about 62 people will take part in this research study
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Perform 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
Maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise (aerobic and resistance exercise) program after 16 weeks.
Time frame: baseline to 4 months
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 months
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 months
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 months
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 months
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 months
Grip strength will be measured using a hand-held dynamometer on the participant's dominant hand. The subject will be asked to grip the handle of the dynamometer with one hand using as much grip pressure (kg) as possible while holding for 2 seconds. The subject will be asked to complete 2 grip strength attempts.
Time frame: baseline to 4 months
Fat mass (kg) will be obtained from a whole-body dual-energy x-ray absorptiometry scan (DXA; Lunar DPX-IQ), which provides highly accurate results compared to computed tomography, a gold standard measure of body composition.
Time frame: baseline to 4 months
Percent body fat will be obtained from a whole-body dual-energy x-ray absorptiometry scan (DXA; Lunar DPX-IQ), which provides highly accurate results compared to computed tomography, a gold standard measure of body composition.
Time frame: baseline to 4 months
Lean mass (kg) will be obtained from a whole-body dual-energy x-ray absorptiometry scan (DXA; Lunar DPX-IQ), which provides highly accurate results compared to computed tomography, a gold standard measure of body composition.
Time frame: baseline to 4 months
A constant-tension tape measure will be used to obtain waist circumference (i.e., the distance around the waist using the umbilicus as the reference point) (cm).
Time frame: baseline to 4 months
A constant-tension tape measure will be used to obtain hip circumference (the distance around the widest girth of the buttocks using the greater trochanter as a landmark) (cm).
Time frame: baseline to 4 months
European Organization for Research and Treatment of Cancer- Quality of Life Questionnaire-C30 will assess health-related quality of life, consisting of substacles including functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures. The score ranges from 0 to 100 and a higher value indicates a better quality of life.
Time frame: baseline to 4 months
Expanded Prostate Cancer Index Composite-26 will assess prostate cancer-specific symptoms (e.g., urinary incontinence, sexual dysfunction, and bowel dysfunction). The score ranges from 0 to 100 and a higher value indicates a worse symptom.
Time frame: baseline to 4 months
MD Anderson Symptom Inventory will assess cancer treatment symptoms (e.g., pain, neuropathy). The score ranges from 0 to 10 and a higher value indicates a worse symptom.
Time frame: baseline to 4 months
The Rosenberg Self-Esteem Scale will assess self-esteem. The score ranges from 10 to 40 and a higher value indicates a better self-esteem.
Time frame: baseline to 4 months
The Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure will be assessed at post-intervention to measure participant-perceived intervention feasibility and acceptability. Each measure has four items with 5-point likers scale. The values in each measure will be the mean of four items and range from 5-20. A higher value means a more acceptable, appropriate, and feasible intervention, perceived by participants, respectively.
Contact information is provided by the study sponsor or research team.
Dana-Farber Cancer Institute
Other
Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04500080
Androgen Deprivation Therapy, Behavior
Reggio Emilia, Emilia-Romagna, Italy
View Trial DetailsNCT06957691
Adenocarcinoma, Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
Boston, Massachusetts, United States
View Trial DetailsNCT07032584
Androgen Deprivation Therapy, Genital Diseases
Salt Lake City, Utah, United States
View Trial DetailsNCT05781217
Androgen Deprivation Therapy, Biochemical Recurrence
L'Hospitalet de Llobregat, Barcelona, Spain
View Trial Details