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

NCT05014035 | Completed

• 1 other identifier: Pro00110261
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer; Resistance Exercise

Keywords

Exercise; Physical Activity; Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Recruitment

  The recruitment goal of n=15 is reached

  Through study completion, an average of 1 year

• Retention

  If ≥75% of the sample recruited to participate return for follow up testing

  Through study completion, an average of 1 year

• 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 Outcomes (15)

• Acceptability

  At post intervention (8-weeks)

• Dyspnea

  Baseline and post intervention (8-weeks)

• Fatigue

  Baseline and post intervention (8-weeks)

• Lung Cancer Related Quality of Life

  Baseline and post intervention (8-weeks)

• Upper Body Muscular Strength

  Baseline and post intervention (8-weeks)

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Behavioral: Resistance Exercise

Interventions

Resistance Exercise 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.

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29201, United States

Location

Related Publications (1)

• Fairman CM, Owens OL, Kendall KL, Steele J, Schumpp AR, Latella C, Jones MT, Marcotte L, Dawson JM, Peddle-McIntyre CMJ, McDonnell KK. Hybrid delivery of cluster-set resistance training for individuals previously treated for lung cancer: the results of a single-arm feasibility trial. Pilot Feasibility Stud. 2023 Oct 17;9(1):177. doi: 10.1186/s40814-023-01405-z.

  PMID: 37848969 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Motor Activity; Lung Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-arm feasibility trial

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 20, 2021
• Study Start: January 1, 2022
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: All de-identified data and code for analyses will be made available as soon as possible with publication of the primary outcome paper.
• Access Criteria: We will make the de-identified data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.

Locations

US (1)