Clinical trial NCT05014035: Feasibility of a Hybrid Delivery of Home-based Cluster Set Resistance Training in Lung Cancer
Official title: Feasibility of a Hybrid Delivery of Home-based Cluster Set Resistance Training in Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Resistance Exercise
Keywords: Exercise
Physical Activity
Lung Cancer
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm feasibility trial
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment
timeFrame: Through study completion, an average of 1 year
measure: Retention
timeFrame: Through study completion, an average of 1 year
measure: Intervention Fidelity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Acceptability
timeFrame: At post intervention (8-weeks)
measure: Dyspnea
timeFrame: Baseline and post intervention (8-weeks)
measure: Fatigue
timeFrame: Baseline and post intervention (8-weeks)
measure: Lung Cancer Related Quality of Life
timeFrame: Baseline and post intervention (8-weeks)
measure: Upper Body Muscular Strength
timeFrame: Baseline and post intervention (8-weeks)
measure: Lower Body Muscular Strength
timeFrame: Baseline and post intervention (8-weeks)
measure: Physical Function STS
timeFrame: Baseline and post intervention (8-weeks)
measure: Physical Function 6MWT
timeFrame: Baseline and post intervention (8-weeks)
measure: Fat Mass
timeFrame: Baseline and post intervention (8-weeks)
measure: Fat Free Mass
timeFrame: Baseline and post intervention (8-weeks)
measure: Total Mass
timeFrame: Baseline and post intervention (8-weeks)
measure: Body Fat Percentage
timeFrame: Baseline and post intervention (8-weeks)
measure: Appendicular Lean Mass
timeFrame: Baseline and post intervention (8-weeks)
measure: Bone Mineral Density
timeFrame: Baseline and post intervention (8-weeks)
measure: Acceptability
timeFrame: Post-Intervention (8-weeks)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References: