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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a live, supervised group exercise program by video is practical and helpful for World Trade Center responders who have had prostate cancer. It will also look at changes in movement, activity, and quality of life. Participants are assigned by chance to exercise three times a week for 16 weeks or to receive usual care and be offered the program later.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate cancer certified by the WTC Health Program.
  • Have finished initial prostate cancer treatment, such as surgery or radiation. People being closely watched without treatment or taking medicine to lower male hormones may also join.
  • Do less than 90 minutes of moderate-to-hard activity per week, fewer than two strength-training sessions per week, or both.
  • Can understand the study and give written consent online or by mail.
  • Are willing and able to join exercise sessions by video.

Who can't join

  • Have cancer that has spread to distant parts of the body.
  • Cannot walk independently, even with a walking aid.
  • Have moderate or severe problems with memory or thinking.
  • Cannot communicate in English.
  • Cannot or will not attend exercise sessions three times a week for 16 weeks.
  • Are in another organized exercise program or clinical trial that could affect this study’s results.
  • Have an unstable or serious health condition that could make exercise unsafe or prevent participation, such as uncontrolled heart disease, severe mental illness, or organ failure.
  • Have an implanted device that shocks the heart to correct dangerous rhythms (ICD), or a recent blood clot in a deep vein in the leg.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 \-

Study sites (1)

VT