Feasibility of a Hybrid Delivery of Home-based Cluster Set Resistance Training in Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Retention
时间窗: Through study completion, an average of 1 year
If ≥75% of the sample recruited to participate return for follow up testing
Intervention Fidelity
时间窗: 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.
Recruitment
时间窗: Through study completion, an average of 1 year
The recruitment goal of n=15 is reached
次要结局
- Lower Body Muscular Strength(Baseline and post intervention (8-weeks))
- Bone Mineral Density(Baseline and post intervention (8-weeks))
- Dyspnea(Baseline and post intervention (8-weeks))
- Acceptability(Post-Intervention (8-weeks))
- Fatigue(Baseline and post intervention (8-weeks))
- Physical Function STS(Baseline and post intervention (8-weeks))
- Total Mass(Baseline and post intervention (8-weeks))
- Appendicular Lean Mass(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))
- Physical Function 6MWT(Baseline and post intervention (8-weeks))
- Fat Mass(Baseline and post intervention (8-weeks))
- Fat Free Mass(Baseline and post intervention (8-weeks))
- Body Fat Percentage(Baseline and post intervention (8-weeks))
研究者
Ciaran Fairman
Assistant Professor
University of South Carolina