Copd, Fatigue
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTL-carnitine 1000 mg twice daily
Oral L-carnitine to be taken twice daily for 8 weeks
BEHAVIORALWeekly health coaching calls
Weekly health coaching calls lasting 10-15 minutes
DIETARY_SUPPLEMENTPlacebo capsules
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ) | baseline, end of 8 week intervention | The CRQ is a widely utilized and validated interviewer-administered questionnaire measuring both physical and emotional aspects of chronic respiratory disease. There are 20 questions, with each item graded on 7-point Likert scale. Scores can range from 20 to 100. Higher scores indicate better quality of life. |
| Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11) | baseline, end of 8 week intervention | The CFQ-11 is a well-known, widely utilized and validated self-administered questionnaire for measuring the extent and severity of fatigue. The scoring incorporates two self-assessment scales measuring components indicative of physical fatigue \[8 items\] and mental fatigue \[5 items\]. The 11 individual items are scored from 0 (better than usual) to 3 (much worse than usual); total score range: 0-33. |
| Physical Activity as Measured by the SenseWear Armband | end of 8 week intervention | The SenseWear Armband system (Temple Healthcare) is a versatile arm-band monitor allowing convenient and accurate collection of raw data regarding energy expenditure, sleep duration and quality, physical activity and movement in subjects in a free-living environment, allowing them to go about their normal daily activities. Patients will be shown how to wear the activity monitor and be asked to use it for at least 5 days for 23 hours a day. They will be provided instructions and pre-paid shipping materials for wear and return of the monitor. |
Countries
United States
Outcome results
None listed