Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07440641

RE-FIT (Remote Exercise for Physical Function in 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

55 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Primary outcomes

  1. Recruitment Rate

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

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

  2. Retention Rate

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

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

  3. Intervention Adherence

    Time frame: Weeks 1-16 of the intervention period

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

  4. Assessment Completion Rate

    Time frame: Baseline through 16-week post-intervention assessment

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

Secondary outcomes

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

    Time frame: Baseline to 16 weeks

    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.

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

    Time frame: Baseline and Week 16

    Total score on the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. Higher scores indicate better quality of life.

  3. Change in Physical Function Measured by PROMIS-29

    Time frame: Baseline and Week 16

    PROMIS-29 Physical Function T-score. Higher scores indicate better physical function.

  4. Change in Fatigue Measured by PROMIS-29

    Time frame: Baseline and Week 16

    PROMIS-29 Fatigue T-score. Higher scores indicate worse fatigue.

  5. Change in Sleep Disturbance Measured by PROMIS-29

    Time frame: Baseline and Week 16

    PROMIS-29 Sleep Disturbance T-score. Higher scores indicate worse sleep disturbance.

  6. Change in Pain Interference Measured by PROMIS-29

    Time frame: Baseline and Week 16

    PROMIS-29 Pain Interference T-score. Higher scores indicate greater pain interference.

  7. Change in Anxiety Measured by PROMIS-29

    Time frame: Baseline and Week 16

    PROMIS-29 Anxiety T-score. Higher scores indicate worse anxiety.

  8. Change in Average Daily Step Count Measured by activPAL Accelerometer

    Time frame: Baseline to 16 weeks

    Average number of steps per day measured using a thigh-worn activPAL accelerometer worn continuously for 7 consecutive days.

  9. Change in Depression Measured by PROMIS-29

    Time frame: Baseline and Week 16

    PROMIS-29 Depression T-score. Higher scores indicate worse depressive symptoms.

  10. Change in Ability to Participate in Social Roles Measured by PROMIS-29

    Time frame: Baseline and Week 16

    PROMIS-29 Ability to Participate in Social Roles T-score. Higher scores indicate better social participation.

  11. Change in Functional Capacity Measured by Duke Activity Status Index (DASI)

    Time frame: Baseline and Week 16

    Duke Activity Status Index (DASI) total score estimating functional capacity. Higher scores indicate greater functional capacity.

  12. Change in Short Physical Performance Battery (SPPB) Total Score

    Time frame: Baseline to 16 weeks

    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.

  13. Change in SPPB Balance Score

    Time frame: Baseline to 16 weeks

    Balance subtest score (0-4) from the Short Physical Performance Battery. Higher scores indicate better balance performance.

  14. Change in Timed Up and Go (TUG) Test Time

    Time frame: Baseline to 16 weeks

    Time in seconds required to stand from a seated position, walk 3 meters, turn, return, and sit down. Lower values indicate better mobility.

  15. Change in Two-Minute Step Test Performance

    Time frame: Baseline to 16 weeks

    Number of step-raises completed in two minutes, meeting standardized knee-height criteria. Higher values indicate better aerobic endurance.

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy Gell, PhD

CONTACT

[email protected]

1 (802) 656-9265

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

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

Acronym: RE-FIT

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.