NCT05014035

Feasibility of a Hybrid Delivery of Home-based Cluster Set Resistance Training in Lung Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Symptom burden remains a critical concern for individuals with non-small cell lung cancer (NSCLC) following the completion of treatment. Of those, symptom clusters such as dyspnea (shortness of breath) and fatigue, contribute to physical decline, reductions in quality of life, and a higher risk of comorbidities and mortality. It has been proposed that dyspnea is a primary limiter of exercise capacity in individuals with lung cancer, resulting in exercise avoidance and an accelerated physical decline. As such, specifically designing resistance exercise programs with cluster sets, to mitigate feelings of dyspnea and fatigue may result in improved exercise tolerance, resulting in the maintenance of physical function and quality of life. The purpose of this project is to investigate the feasibility and preliminary efficacy of a hybrid-delivery of home-based cluster-set resistance exercise in individuals with NSCLC. Methods: Individuals with NSCLC (n=15), within 12-months of completion of treatment will be recruited to participate in this single arm feasibility trial. Participants will complete 8-weeks of home-based resistance training (RT) designed to target dyspnea and fatigue. The hybrid-delivery of the program will include supervised sessions in the participants home, and virtual supervision via video conferencing. The primary outcome of feasibility will be measured via recruitment rates, retention, acceptability and intervention fidelity. Exploratory outcomes (dyspnea, fatigue, quality of life, physical function and body composition) will be assessed pre- and post- intervention.

Detailed description

Analysis plan. Descriptive statistics (percentages and means (with standard deviations)) will be used to report on feasibility outcomes (recruitment, retention, fidelity etc.). Unless explicitly stated, means and standard deviations will be reported for assessments of exploratory outcomes at baseline and follow-up.

Conditions

• Non Small Cell Lung Cancer
• Resistance Exercise

Interventions

Type	Name	Description
BEHAVIORAL	Resistance Exercise	This is an 8-week exercise program, delivered using a hybrid approach of in-person, in-home supervised exercise, and virtual delivery of exercise via zoom. Individuals will participate in resistance exercise 3 days per week for 8 weeks.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2021-08-20
• Last updated: 2023-05-12

Locations

1 site across 1 country: United States