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

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont
Study ID
NCT07440641
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remote Supervised Exercise Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Feb 2026
Primary completion
Jan 20, 2035
Completion
Jan 20, 2035

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Remote Exercise Intervention
    Participants randomized to this arm will participate in a remotely delivered, supervised group exercise program conducted via live videoconferencing. The intervention consists of three 60-minute exercise sessions per week for 16 weeks. Sessions include aerobic, strength, balance, and flexibility exercises and are led by a certified instructor with real-time supervision and safety monitoring. Exercise intensity and progression are individualized based on participant ability and perceived exertion. Participants complete study assessments at baseline and post-intervention, including remote physical function testing, patient-reported outcome questionnaires, wearable physical activity monitoring, and optional saliva collection.
  • No Intervention: Waitlist Control
    Participants randomized to the waitlist control arm will receive usual medical care and will not participate in the study exercise program during the 16-week study period. They will complete the same study assessments as the intervention arm at baseline and post-intervention, including remote physical function testing, patient-reported outcome questionnaires, wearable physical activity monitoring, and optional saliva collection. After completion of all post-intervention assessments, participants in the waitlist control arm will be offered the remote exercise program; data collected during this post-study period will not be included in the primary analyses.

Primary Outcome Measure

Recruitment Rate [ Time Frame: Recruitment assessed from study start through completion of enrollment (up to 24 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VermontBurlingtonVermont05401-

Find similar trials in Burlington, VT

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Vermont· Burlington, VT

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