Remote Exercise for Prostate Cancer

(RE-FIT Trial)

NG
Overseen ByNancy Gell, PhD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Vermont
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a Remote Supervised Exercise Program can benefit World Trade Center responders with prostate cancer. Many of these men experience fatigue and a reduced quality of life after cancer treatment. The study aims to determine if a video-based exercise routine, performed three times a week, can enhance physical strength and well-being. Men who have undergone prostate cancer treatment, exercise less than 90 minutes a week, and can participate in video workouts might be suitable candidates. The trial will also assess whether participants can collect saliva samples at home for future research. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve the quality of life for others facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants may be on active surveillance or receiving androgen deprivation therapy, suggesting that some medications might be allowed.

What prior data suggests that this remote exercise program is safe for prostate cancer patients?

Previous studies have found remote exercise programs for prostate cancer patients to be safe and well-tolerated. Research shows that participants completed most exercise sessions, with men finishing 90% of aerobic sessions and 96% of resistance training sessions. Other studies have found that supervised exercise programs are generally safe and can enhance the quality of life for individuals with prostate cancer.

These studies reported no serious side effects, indicating that participants did not experience major health problems from the exercise. The exercises, including heart-pumping aerobic activities, strength, balance, and flexibility exercises, are designed to be safe for people with varying fitness levels. These findings suggest that joining a remote exercise program could safely improve physical function and well-being for WTC Responders with prostate cancer.12345

Why are researchers excited about this trial?

Researchers are excited about the Remote Supervised Exercise Program for prostate cancer because it offers a unique, accessible approach to managing the condition. Unlike traditional in-person exercise programs, this treatment is delivered remotely via live videoconferencing, making it more convenient for participants to join from their homes. The program's individualized approach, which tailors exercise intensity and progression based on each participant's ability, ensures safety and maximizes effectiveness. Additionally, the inclusion of a certified instructor providing real-time supervision and safety monitoring enhances participant confidence and engagement.

What evidence suggests that this remote exercise program is effective for prostate cancer?

Research shows that supervised exercise can greatly improve the quality of life for prostate cancer patients. In this trial, participants in the Remote Exercise Intervention arm will follow a remote exercise program, which studies have shown significantly improves health and reduces symptoms for these patients. Such exercise programs can also help prevent weight gain, lower blood pressure, and improve physical abilities. Feedback from similar trials indicates that participants find remote supervised programs easy to follow and helpful. Overall, these findings suggest that the exercise program could enhance physical function and well-being for participants.23567

Are You a Good Fit for This Trial?

This trial is for World Trade Center responders who have had prostate cancer, finished their initial treatment, and currently do little regular exercise. Participants must be able to walk on their own, use videoconferencing, understand English, and not have serious medical issues or metastatic cancer.

Inclusion Criteria

I have prostate cancer certified by the WTC Health Program.
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)
See 2 more

Exclusion Criteria

Implanted cardioverter defibrillator (ICD) or recent lower extremity deep vein thrombosis
My cancer has spread to other parts of my body.
Unable or unwilling to attend scheduled exercise sessions (three times per week for 16 weeks)
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the exercise group will attend three one-hour exercise sessions per week using videoconferencing for 16 weeks

16 weeks
48 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including remote physical function testing and questionnaires

4 weeks

Waitlist Control

Participants in the waitlist control group receive usual care during the 16-week study period and are offered the exercise program after completing all study assessments

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Remote Supervised Exercise Program

Trial Overview

The study tests a live, remote group exercise program delivered by video three times a week for 16 weeks versus usual care (waitlist). It aims to see if the program is practical and helpful in improving physical function and quality of life.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Remote Exercise InterventionExperimental Treatment1 Intervention
Group II: Waitlist ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials
283
Recruited
3,747,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials
933
Recruited
579,000+

Citations

Improving Quality of Life Through Supervised Exercise ... - PMC

Conclusions: Supervised therapeutic exercise is associated with significant improvements in QoL in breast and prostate cancer patients. Combined and well- ...

Home-based versus supervised group exercise in men ...

A HOME exercise intervention appears non-inferior to GROUP for fatigue and functional endurance and requires fewer resources to implement.

Impact of adherence to a remote exercise program on ...

This study demonstrates that adherence to a remote exercise program significantly improves HRQoL and reduces symptom burden in patients with prostate cancer ...

Clinical Research Trial Listing ( Prostate Cancer ...

Comparison of the Effectiveness of Supervised, Video-based and Home-based Resistance Exercise Program in Patients With Prostate Cancer.

Home-based exercise improves quality of life in breast and ...

Conclusions. Home-based exercise results in small improves QoL in BCa/PCa survivors, independent of cancer type, intervention duration and type, or age.

Feasibility, safety, and acceptability of a remotely monitored ...

Men who completed the remote intervention attempted 90% and 96% of prescribed aerobic and resistance training sessions, respectively, and 86% ...

A Clinical trial of High-intensity Aerobic and resistance ...

Conclusions: Remotely monitored exercise training is feasible, safe, and acceptable in men with mCRPC; there was no difference in these outcomes by mode of ...