L-carnitine for Fatigue in COPD
关键词
抽象
日期
| 最后验证: | 12/31/2018 |
| 首次提交: | 12/27/2016 |
| 提交的预估入学人数: | 12/27/2016 |
| 首次发布: | 01/01/2017 |
| 上次提交的更新: | 01/20/2019 |
| 最近更新发布: | 01/22/2019 |
| 实际学习开始日期: | 12/31/2016 |
| 预计主要完成日期: | 01/31/2018 |
| 预计完成日期: | 01/31/2018 |
状况或疾病
干预/治疗
Dietary Supplement: L-carnitine 1000 mg twice daily
Behavioral: L-carnitine + health coaching
Dietary Supplement: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: L-carnitine Oral L-carnitine 1000mg twice daily | |
| Experimental: L-carnitine + health coaching Oral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls | Behavioral: L-carnitine + health coaching Weekly health coaching calls lasting 10-15 minutes |
| Placebo Comparator: Placebo Placebo capsules twice daily | Dietary Supplement: Placebo |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion criteria: - COPD patients with a positive screen for fatigue Exclusion criteria: - Vulnerable population - pregnant women, prisoners, unable to provide consent - Pre-menopausal/breastfeeding women (pregnancy category B) - Thyroid disease - Anticoagulation therapy - Decompensated cardiac disease - Chronic Kidney Disease (CKD4 or above) - Known seizure disorder - Active malignancy - Exacerbation of underlying pulmonary disease or acute illness in the 6 weeks before screening - Enrollment in the past 6 weeks or currently in a cardiac or pulmonary rehab program or other physical fitness class(es). - Difficulty with swallowing pills |
结果
主要结果指标
1. Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT) [baseline, end of 8 week intervention]
次要成果指标
1. Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ) [baseline, end of 8 week intervention]
2. Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11) [baseline, end of 8 week intervention]
3. Physical Activity as Measured by the SenseWear Armband [end of 8 week intervention]
