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Completed

NCT Number: NCT05014035

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

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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Key information

Conditions

Non Small Cell Lung Cancer Behavior Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Resistance Exercise Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Recruitment

    Time frame: Through study completion, an average of 1 year

    The recruitment goal of n=15 is reached

  2. Retention

    Time frame: Through study completion, an average of 1 year

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

  3. Intervention Fidelity

    Time frame: Through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Acceptability

    Time frame: At post intervention (8-weeks)

    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

  2. Dyspnea

    Time frame: Baseline and post intervention (8-weeks)

    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

  3. Fatigue

    Time frame: Baseline and post intervention (8-weeks)

    Functional Assessment of Chronic Illness Therapy-Fatigue scale 13-item scale. Min score: 0 Max score: 52 Higher scores mean higher quality of life.

  4. Lung Cancer Related Quality of Life

    Time frame: Baseline and post intervention (8-weeks)

    Functional Assessment of Cancer Therapy - Lung Cancer Subscale (LCS). Min score: 0; max score: 28. Higher scores indicate better quality of life.

  5. Upper Body Muscular Strength

    Time frame: Baseline and post intervention (8-weeks)

    Chest Press five repetition maximum

  6. Lower Body Muscular Strength

    Time frame: Baseline and post intervention (8-weeks)

    Leg Press five repetition maximum

  7. Physical Function STS

    Time frame: Baseline and post intervention (8-weeks)

    5 times sit-to-stand (in seconds)

  8. Physical Function 6MWT

    Time frame: Baseline and post intervention (8-weeks)

    6-minute Walk Test (distance in meters)

  9. Fat Mass

    Time frame: Baseline and post intervention (8-weeks)

    Fat mass (kg) Dual Energy X-Ray Absorptiometry

  10. Fat Free Mass

    Time frame: Baseline and post intervention (8-weeks)

    Fat Free Mass (kg) Dual Energy X-Ray Absorptiometry

  11. Total Mass

    Time frame: Baseline and post intervention (8-weeks)

    Total Mass (kg) Dual Energy X-Ray Absorptiometry

  12. Body Fat Percentage

    Time frame: Baseline and post intervention (8-weeks)

    Dual Energy X-Ray Absorptiometry

  13. Appendicular Lean Mass

    Time frame: Baseline and post intervention (8-weeks)

    Sum of Arm and Leg Fat Free Mass

  14. Bone Mineral Density

    Time frame: Baseline and post intervention (8-weeks)

    Total z-score Dual X-ray Absorptiometry

  15. Acceptability

    Time frame: Post-Intervention (8-weeks)

    Qualitative interview with participants regarding the acceptability, likes, dislikes about the intervention and potential barriers for future participation.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2021
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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