Tele-Resistance Training for Gastrointestinal Cancer

Overseen By Nathan Parker, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Unstable cardiac, Pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.

How is Tele-Resistance Training different from other treatments for gastrointestinal cancer?

Tele-Resistance Training is unique because it allows patients to perform resistance exercises remotely from their homes using video-conferencing technology, making it more accessible and convenient compared to traditional in-person exercise programs. This approach is particularly beneficial for those who have difficulty attending facility-based programs due to distance or other commitments. ¹

Research Team

Nathan Parker, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for adults over 18 with advanced upper gastrointestinal cancer who are undergoing chemotherapy and can return to Moffitt Cancer Center for check-ups. They should be relatively active (able to care for themselves or do light work) and speak English fluently. People already doing regular resistance training, in severe pain, with recent fractures, muscle diseases, or serious heart/lung conditions cannot join.

Inclusion Criteria

I am 18 years old or older.

My upper GI cancer is confirmed by biopsy and is stage III-IV.

I am fully active or can carry out light work.

Exclusion Criteria

I have a muscle or joint disease that affects my ability to move.

I regularly exercise, focusing on all major muscle groups twice a week.

I haven't had a recent fracture or injury that stops me from undergoing radiation therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of muscular strength, endurance, and clinicodemographic characteristics

1 week

Treatment

Participants undergo a tele-resistance training exercise program for 12 weeks, including resistance and aerobic exercises

12 weeks

Remote monitoring with FitBit

Follow-up

Participants are monitored for safety, effectiveness, and retention feasibility after treatment

Up to 6 months

Treatment Details

Interventions

• Tele-Resistance Training

Trial Overview The study tests a tele-resistance training exercise program designed for patients receiving chemotherapy for advanced upper GI cancers. The goal is to see if exercising from home using remote guidance can benefit these individuals during their treatment.

Participant Groups

Group I: Tele-Resistance Training (RT) Experimental Treatment 1 Intervention

Participants will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week for 12 weeks. Participants will also be encouraged to perform moderate aerobic exercise at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.

Group II: Usual Care (UC) Active Control 1 Intervention

Participants randomized to the Usual Care (UC) arm will be provided with information materials outlining resistance training using body weight or basic equipment. Participants will wear a FitBit fitness watch to monitor aerobic exercise.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The ReStOre@Home program, a virtual 12-week rehabilitation intervention for patients who have completed treatment for oesophago-gastric cancer, aims to assess feasibility through recruitment, adherence, and acceptability among 12 participants.

This study will evaluate various outcomes, including physical performance and quality of life, to determine if a remote, multidisciplinary approach can effectively support UGI cancer survivors during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol. O'Neill, L., Guinan, E., Brennan, L., et al.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol. [2021]