Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy

Официальное название

Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial

Обзор

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.

Подробное описание

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.

* Aerobic and resistance exercise - virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom.The exercise group will be asked to perform exercise at home with virtual supervision, including aerobic exercise. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer. * Usual care - maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise program after 16 weeks. The usual care group will be asked to maintain their current exercise levels and will be offered the same exercise intervention after the completion of the study.

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

Вмешательства

• Другое Aerobic and resistance exercise
  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
• Другое Usual Care
  Maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise (aerobic and resistance exercise) program after 16 weeks.

Первичные конечные точки

• Cardiovascular disease risk factors [Срок оценки: baseline to 4 months]

Вторичные конечные точки (12)

• Cardiorespiratory capacity [Срок оценки: baseline to 4 months]
• Muscular strength [Срок оценки: baseline to 4 months]
• Short Physical Performance Battery (SPPB) [Срок оценки: baseline to 4 months]
• Timed-Up-and-Go (TUG) [Срок оценки: baseline to 4 months]
• Hand grip strength [Срок оценки: baseline to 4 months]
• Fat mass [Срок оценки: baseline to 4 months]
• Percent body fat [Срок оценки: baseline to 4 months]
• Lean mass [Срок оценки: baseline to 4 months]
• Hip circumference [Срок оценки: baseline to 4 months]
• Waist circumference [Срок оценки: baseline to 4 months]
• Health-related quality of life - EORTC-QLQ C30 [Срок оценки: baseline to 4 months]
• Prostate cancer-specific symptoms - EPIC-26 [Срок оценки: baseline to 4 months]

Критерии участия

Критерии включения

• 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
• Self-identify as Black
• Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist
• Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases
• Speak English and/or Spanish
• Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week
• Willing to travel to DFCI for necessary data collection
• Ability to communicate and complete written forms in English and/or Spanish

Критерии исключения

• 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)
• Participate in more than 60 minutes of moderate or vigorous structured exercise/week
• Unable to travel to DFCI for necessary data collection
• May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Dana Farber Cancer Institute — Boston

Публикации

• Kang DW, Ficarra S, Wilson RL, Morgans AK, Nguyen PL, Rebbeck TR, Einstein DJ, Uno H, Mossanen M, Hill DM, Gonzalo-Encabo P, Norris MK, Gardiner J, Tjogas D, Greer J, Dieli-Conwright CM. Exercise to enhance cardiovascular health among black men with prostate cancer with androgen deprivation therapy (the POWER trial): A study protocol. Contemp Clin Trials. 2025 Aug;155:107973. doi: 10.1016/j.cct.20 PMID 40451460

Идентификаторы

NCT: NCT05327465 · 21-741

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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