Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
NCT Number: NCT03070145
This research study is evaluating the impact and feasibility of a 12-week brisk walking and moderate strength training exercise intervention including a virtual component in men who are initiating androgen deprivation therapy (ADT) for prostate cancer
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Notify Me18 year–80 year
Male
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Androgen deprivation therapy (ADT) is a key treatment of prostate cancer. While this therapy improves prostate cancer outcomes, ADT also has a variety of short- and long-term adverse effects, including increased body weight, loss of lean muscle mass, reductions in quality of life, and increased risk of cardiovascular disease. Studies have shown that among men with prostate cancer, physical activity is associated with improved outcomes, including a reduced risk of mortality, from prostate cancer and other causes. Our hypothesis is that physical activity will improve some of the physical and emotional side effects associated with ADT. Physical activity, such as brisk walking and moderate strength training, offers a lifestyle factor that may improve some of the side effects, and is low-cost and easy to do.
The investigators are conducting this study to evaluate the impact and feasibility of a 12-week moderate-intensity aerobic and strength training exercise intervention, including a virtual component. The intervention includes brisk walking and moderate strength training, and involves home-based exercises, in-person sessions with an oncology-trained exercise physiologist, optional group training sessions, and weekly training goals. Participants will have access to a personalized web-based platform called Postwire, which will include videos of training sessions, and will allow participants to easily communicate with the study staff and with other study participants.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12-week moderate-intensity aerobic and strength training exercise intervention
Time frame: Baseline and 12 weeks
The 6 Minute Walk Test will be performed at the clinic, where the participants will wear tennis shoes and will walk indoors on a flat surface for 6 minutes.
Time frame: Baseline and 12 weeks
Measuring heart rate and resting pulse by counting the number of beats per minute at the wrist of each participant.
Time frame: Baseline and 12 weeks
The investigators will obtain participant's blood pressure from the most recent clinical visit.
Time frame: Baseline and 12 weeks
Obtain body composition (total fat and lean body mass) by conducting dual energy X-ray absorptiometry (DEXA) scans.
Time frame: Baseline and 12 weeks
The Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function.
Time frame: Baseline and 12 weeks
The investigators will assess changes in physical functioning from study enrollment to the completion of the study period using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3) and the Prostate Cancer Specific EORTC questionnaire.
Time frame: Baseline and 12 weeks
The investigators will assess changes in activity from baseline to 12-weeks using the 7-Day Physical Activity Recall (PAR)
Time frame: Baseline and 12 weeks
The investigators will assess changes in height from baseline to 12 weeks using a tape measure.
Time frame: Baseline and 12 weeks
The investigators will assess changes in weight from baseline to 12 weeks using a scale.
Time frame: Baseline and 12 weeks.
The investigators will assess changes in waist circumference from baseline to 12 weeks using a tape measure.
Time frame: Baseline and 12 weeks.
The investigators will assess PSA at baseline and 12-weeks in both the usual care and intervention arm.
Time frame: Baseline and 12 weeks.
The investigators will assess testosterone levels at baseline and 12-weeks in both the usual care and intervention arm.
Time frame: Baseline and 12 weeks
The investigators will evaluate adherence rates to study procedures by using self-report and FitBit
Time frame: Baseline and 12 weeks
Feasibility measured by number of eligible members of the targeted population
Time frame: Baseline and 12 weeks
Feasibility measured by recruitment rates
Time frame: Baseline and 12 weeks
Feasibility measured by refusal rates for participation and randomization
Time frame: Baseline and 12 weeks
Feasibility measured by level of engagement with Postwire and with other study participants.
Dana-Farber Cancer Institute
Other
Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy: A Pilot Study
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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.
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