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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-09-22

Brief Summary

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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.

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Detailed Description

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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

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Non Small Cell Lung Cancer Resistance Exercise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm feasibility trial

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Exercise Intervention

Group Type EXPERIMENTAL

Resistance Exercise

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Completed definitive treatment for localized NSCLC (stages I-III)
* Has access to stable internet access for Zoom participation
* Willing to complete an 8-week, home-based intervention program that includes face-to-face and Zoom interaction.
* Willing to consider behavior change at this time.
* Able to speak and read English.
* Capable of informed consent
* Has obtained medical clearance from medical practitioner or medical team

Exclusion Criteria

* Individuals with a known diagnosis of advanced lung cancer (stage IV; due to potential added burden) or diagnosis of small-cell lung cancer,
* Anyone for whom physical activity is not recommended.
* aren't comfortable having study staff visit their homes for exercise sessions
* have any neuromuscular, cardiovascular, or psychological condition precluding safe exercise;
* have participated in structured RE ≥2 times/week for the past 6 months;
* are unable to read/understand English.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No