Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT03008356
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Rochester, Minnesota, 55905, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral L-carnitine to be taken twice daily for 8 weeks
Weekly health coaching calls lasting 10-15 minutes
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Mayo Clinic
Other
L-Carnitine Supplementation With and Without Health Coaching for Fatigue in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Acronym: LC4COPD
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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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