L-Carnitine Supplementation With and Without Health Coaching for Fatigue in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT)
研究概览
简要总结
supplementation with L-carnitine that is available both as an FDA-approved therapy for primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic aid will improve wellbeing and function measured by questionnaires in patient with chronic obstructive pulmonary disease (COPD).
based on our review of literature that addition of health coaching (HC) to L-carnitine will yield greater gains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
L-carnitine
Oral L-carnitine 1000mg twice daily
干预措施: L-carnitine 1000 mg twice daily (Dietary Supplement)
L-carnitine + health coaching
Oral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls
干预措施: L-carnitine 1000 mg twice daily (Dietary Supplement)
L-carnitine + health coaching
Oral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls
干预措施: Weekly health coaching calls (Behavioral)
Placebo
Placebo capsules twice daily
干预措施: Placebo capsules (Dietary Supplement)
结局指标
主要结局
Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT)
时间窗: baseline, end of 8 week intervention
The 6MWT is a widely studied, standardized and widely utilized test that evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. The self-paced 6MWT assesses the submaximal level of functional capacity. Most patients do not achieve maximal exercise capacity during the 6MWT; instead, they choose their own intensity of exercise and are allowed to stop and rest during the test.
次要结局
- Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11)(baseline, end of 8 week intervention)
- Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ)(baseline, end of 8 week intervention)
- Physical Activity as Measured by the SenseWear Armband(end of 8 week intervention)