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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05014035
• Other study ID #: Pro00110261
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: September 22, 2022

Study information

• Verified date: May 2023
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Non Small Cell Lung Cancer
• Resistance Exercise

Intervention

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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	The recruitment goal of n=15 is reached	Through study completion, an average of 1 year
Primary	Retention	If =75% of the sample recruited to participate return for follow up testing	Through study completion, an average of 1 year
Primary	Intervention Fidelity	Exercise fidelity will be reported using metrics previously outlines by Fairman et al (2019). Specifically, volume load will be calculated as a function of sets x reps for each exercise and summed to give total volume for each session. We will report the proportion of volume achieved relevant to what was prescribed to give a "relative-dose intensity" (RDI) for each person. RDI will then be averaged and used to determine fidelity to the RT intervention.	Through study completion, an average of 1 year
Secondary	Acceptability	10-item scale adapted from McDonnell et al (PMID: 33118443). Questions assessing the acceptability of the intervention will be scored on a 4-point Likert-Type scale from "Strongly disagree" to "Strongly Agree". Questions will ask about the utility of virtual exercise sessions, use of technology and level of tailoring the intervention	At post intervention (8-weeks)
Secondary	Dyspnea	Functional Assessment of Chronic Illness Therapy-Dyspnea (FACIT-D) 10-Item short form (parts 1 and 2). Part 1 assesses Dyspnea and Part 2 assesses dyspnea-associated functional limitations. Min score for each part: 0; max score for each part: 30. Higher scores indicate worse dyspnea/burden	Baseline and post intervention (8-weeks)
Secondary	Fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue scale 13-item scale. Min score: 0 Max score: 52 Higher scores mean higher quality of life.	Baseline and post intervention (8-weeks)
Secondary	Lung Cancer Related Quality of Life	Functional Assessment of Cancer Therapy - Lung Cancer Subscale (LCS). Min score: 0; max score: 28. Higher scores indicate better quality of life.	Baseline and post intervention (8-weeks)
Secondary	Upper Body Muscular Strength	Chest Press five repetition maximum	Baseline and post intervention (8-weeks)
Secondary	Lower Body Muscular Strength	Leg Press five repetition maximum	Baseline and post intervention (8-weeks)
Secondary	Physical Function STS	5 times sit-to-stand (in seconds)	Baseline and post intervention (8-weeks)
Secondary	Physical Function 6MWT	6-minute Walk Test (distance in meters)	Baseline and post intervention (8-weeks)
Secondary	Fat Mass	Fat mass (kg) Dual Energy X-Ray Absorptiometry	Baseline and post intervention (8-weeks)
Secondary	Fat Free Mass	Fat Free Mass (kg) Dual Energy X-Ray Absorptiometry	Baseline and post intervention (8-weeks)
Secondary	Total Mass	Total Mass (kg) Dual Energy X-Ray Absorptiometry	Baseline and post intervention (8-weeks)
Secondary	Body Fat Percentage	Dual Energy X-Ray Absorptiometry	Baseline and post intervention (8-weeks)
Secondary	Appendicular Lean Mass	Sum of Arm and Leg Fat Free Mass	Baseline and post intervention (8-weeks)
Secondary	Bone Mineral Density	Total z-score Dual X-ray Absorptiometry	Baseline and post intervention (8-weeks)
Secondary	Acceptability	Qualitative interview with participants regarding the acceptability, likes, dislikes about the intervention and potential barriers for future participation.	Post-Intervention (8-weeks)