RE-FIT (Remote Exercise for Physical Function in WTC Responders With Prostate Cancer)

Официальное название

A Pilot Randomized Controlled Trial of Remote Exercise to Improve Physical Function in World Trade Center (WTC) Responders With Prostate Cancer

Обзор

People who responded to the World Trade Center (WTC) disaster on September 11, 2001 were exposed to toxic dust and smoke and have higher rates of certain health problems, including prostate cancer. Many WTC Responders with prostate cancer experience ongoing physical limitations, fatigue, and reduced quality of life, even after completing cancer treatment. Regular exercise can improve strength, balance, physical function, and well-being in people with cancer, but many men with prostate cancer do not meet recommended physical activity levels. Barriers such as travel, health concerns, and lack of access to tailored programs can make it difficult to participate in exercise programs. This pilot study will test whether a remotely delivered, supervised group exercise program is feasible and acceptable for WTC Responders with prostate cancer. The exercise program is delivered live by videoconference and is based on an established, evidence-based program for older adults. It includes aerobic, strength, balance, and flexibility exercises and is designed to be safe, supportive, and accessible to people living in different locations. A total of 40 WTC Responders with a history of prostate cancer will take part in this study. Participants will be randomly assigned to either (1) a 16-week remote exercise program or (2) a waitlist control group that receives usual care during the study period and is offered the exercise program after completing all study assessments. Participants in the exercise group will attend three one-hour exercise sessions per week using videoconferencing. The main goals of this study are to determine whether participants can be successfully recruited and retained, whether they attend and complete the exercise sessions, and whether they find the program acceptable and helpful. The study will also explore whether the exercise program improves physical function, physical activity, and quality of life. Physical function will be measured using simple movement tests performed remotely, and physical activity will be measured using a wearable activity monitor. Participants will also complete questionnaires about their health, physical functioning, and experiences with the program. In addition, this study will evaluate whether it is feasible for participants to collect saliva samples at home and return them by mail for future research. A subset of participants will be invited to complete interviews to share their experiences and provide feedback on how the program could be improved. Results from this pilot study will help inform the design of a larger future trial aimed at improving physical function and quality of life for WTC Responders with prostate cancer through accessible, remotely delivered exercise programs.

Вмешательства

• Поведенческое Remote Supervised Exercise Program
  Intervention Description \* § Definition: Details that can be made public about the intervention, other than the Intervention Name(s) and Other Intervention Name(s), sufficient to distinguish the intervention from other, similar interventions studied in the same or another clinical study. For example, interventions involving drugs may include dosage form, dosage, frequency, and duration. Limit: 1000 characters.

Первичные конечные точки

• Recruitment Rate [Срок оценки: Recruitment assessed from study start through completion of enrollment (up to 24 months)]
• Retention Rate [Срок оценки: From study start through completion of enrollment (up to 24 months)]
• Intervention Adherence [Срок оценки: Weeks 1-16 of the intervention period]
• Assessment Completion Rate [Срок оценки: Baseline through 16-week post-intervention assessment]

Вторичные конечные точки (12)

• Change in Five-Times Sit-to-Stand (5xSTS) Time [Срок оценки: Baseline to 16 weeks]
• Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-General (FACT-G) [Срок оценки: Baseline and Week 16]
• Change in Physical Function Measured by PROMIS-29 [Срок оценки: Baseline and Week 16]
• Change in Fatigue Measured by PROMIS-29 [Срок оценки: Baseline and Week 16]
• Change in Sleep Disturbance Measured by PROMIS-29 [Срок оценки: Baseline and Week 16]
• Change in Pain Interference Measured by PROMIS-29 [Срок оценки: Baseline and Week 16]
• Change in Anxiety Measured by PROMIS-29 [Срок оценки: Baseline and Week 16]
• Change in Average Daily Step Count Measured by activPAL Accelerometer [Срок оценки: Baseline to 16 weeks]
• Change in Depression Measured by PROMIS-29 [Срок оценки: Baseline and Week 16]
• Change in Ability to Participate in Social Roles Measured by PROMIS-29 [Срок оценки: Baseline and Week 16]
• Change in Functional Capacity Measured by Duke Activity Status Index (DASI) [Срок оценки: Baseline and Week 16]
• Change in Short Physical Performance Battery (SPPB) Total Score [Срок оценки: Baseline to 16 weeks]

Критерии участия

Критерии включения

• World Trade Center (WTC) Health Program-certified diagnosis of prostate cancer
• Completed initial treatment for prostate cancer (for example, surgery or radiation); participants may be on active surveillance or receiving androgen deprivation therapy
• Low levels of regular physical activity (less than 90 minutes per week of moderate-to-vigorous activity and/or less than two strength-training sessions per week)
• Able to understand and provide written informed consent (electronically or by mail)
• Willing and able to participate in remotely delivered exercise sessions using videoconferencing

Критерии исключения

• Metastatic cancer
• Unable to ambulate independently, with or without an assistive device
• Moderate or severe cognitive impairment
• Unable to communicate in English
• Unable or unwilling to attend scheduled exercise sessions (three times per week for 16 weeks)
• Current participation in another structured exercise program or clinical trial that could confound study outcomes
• Unstable or serious medical conditions that would pose a safety risk or limit compliance (for example, uncontrolled cardiovascular disease, severe psychiatric illness, or organ failure)

Implanted cardioverter defibrillator (ICD) or recent lower extremity deep vein thrombosis

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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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Vermont — Burlington

Идентификаторы

NCT: NCT07440641 · UVMCC2508

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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