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

NCT07440641 | Not Yet Recruiting DMC

• 1 other identifier: UVMCC2508
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

exercise; World Trade Center Responders; Cancer Survivorship

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  Proportion of eligible participants who enroll in the study among those approached for participation. Unit of Measure: Percentage (%)

  Recruitment assessed from study start through completion of enrollment (up to 24 months)

• Retention Rate

  Proportion of enrolled participants who complete the 16-week post-intervention assessment. Unit of Measure: Percentage (%)

  From study start through completion of enrollment (up to 24 months)

• Intervention Adherence

  Mean percentage of planned exercise sessions attended among participants randomized to the intervention arm (48 planned sessions over 16 weeks). Unit of Measure: Percentage (%)

  Weeks 1-16 of the intervention period

• Assessment Completion Rate

  Proportion of participants completing baseline and post-intervention assessments (physical function testing and questionnaires). Unit of Measure: Percentage (%).

  Baseline through 16-week post-intervention assessment

Secondary Outcomes (15)

• Change in Five-Times Sit-to-Stand (5xSTS) Time

  Baseline to 16 weeks

• Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-General (FACT-G)

  Baseline and Week 16

• Change in Physical Function Measured by PROMIS-29

  Baseline and Week 16

• Change in Fatigue Measured by PROMIS-29

  Baseline and Week 16

• Change in Sleep Disturbance Measured by PROMIS-29

  Baseline and Week 16

Study Arms (2)

Remote Exercise Intervention

EXPERIMENTAL

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.

Behavioral: Remote Supervised Exercise Program

Waitlist Control

NO INTERVENTION

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.

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.

Remote Exercise Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Central Study Contacts

Nancy Gell, PhD

CONTACT

1 (802) 656-9265; nancy.gell@med.uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 20, 2035
• Study Completion (Estimated): January 20, 2035
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)