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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Remote Supervised Exercise Program

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy Gell, PhD; Phone Number: 1 (802) 656-9265; Email: nancy.gell@med.uvm.edu

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Five-Times Sit-to-Stand (5xSTS) Time	Time in seconds required to complete five consecutive sit-to-stand repetitions from a standard chair without use of arms. Lower values indicate better performance.	Baseline to 16 weeks
Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-General (FACT-G)	Total score on the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. Higher scores indicate better quality of life.	Baseline and Week 16
Change in Physical Function Measured by PROMIS-29	PROMIS-29 Physical Function T-score. Higher scores indicate better physical function.	Baseline and Week 16
Change in Fatigue Measured by PROMIS-29	PROMIS-29 Fatigue T-score. Higher scores indicate worse fatigue.	Baseline and Week 16
Change in Sleep Disturbance Measured by PROMIS-29	PROMIS-29 Sleep Disturbance T-score. Higher scores indicate worse sleep disturbance.	Baseline and Week 16
Change in Pain Interference Measured by PROMIS-29	PROMIS-29 Pain Interference T-score. Higher scores indicate greater pain interference.	Baseline and Week 16
Change in Anxiety Measured by PROMIS-29	PROMIS-29 Anxiety T-score. Higher scores indicate worse anxiety.	Baseline and Week 16
Change in Average Daily Step Count Measured by activPAL Accelerometer	Average number of steps per day measured using a thigh-worn activPAL accelerometer worn continuously for 7 consecutive days.	Baseline to 16 weeks
Change in Depression Measured by PROMIS-29	PROMIS-29 Depression T-score. Higher scores indicate worse depressive symptoms.	Baseline and Week 16
Change in Ability to Participate in Social Roles Measured by PROMIS-29	PROMIS-29 Ability to Participate in Social Roles T-score. Higher scores indicate better social participation.	Baseline and Week 16
Change in Functional Capacity Measured by Duke Activity Status Index (DASI)	Duke Activity Status Index (DASI) total score estimating functional capacity. Higher scores indicate greater functional capacity.	Baseline and Week 16
Change in Short Physical Performance Battery (SPPB) Total Score	Total composite score (range 0-12) derived from balance, gait speed, and chair stand components of the Short Physical Performance Battery. Higher scores indicate better physical performance.	Baseline to 16 weeks
Change in SPPB Balance Score	Balance subtest score (0-4) from the Short Physical Performance Battery. Higher scores indicate better balance performance.	Baseline to 16 weeks
Change in Timed Up and Go (TUG) Test Time	Time in seconds required to stand from a seated position, walk 3 meters, turn, return, and sit down. Lower values indicate better mobility.	Baseline to 16 weeks
Change in Two-Minute Step Test Performance	Number of step-raises completed in two minutes, meeting standardized knee-height criteria. Higher values indicate better aerobic endurance.	Baseline to 16 weeks

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 20, 2035
• Study Completion (Estimated): January 20, 2035

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: exercise; Cancer Survivorship; World Trade Center Responders
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Behavior; Prostatic Neoplasms; Motor Activity
• Other Study ID Numbers: UVMCC2508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No