L-carnitine for Fatigue in COPD

Study Overview
=================
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.

Official Title
-----------------
L-Carnitine Supplementation With and Without Health Coaching for Fatigue in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Copd, Fatigue

Intervention / Treatment
-----------------
* Dietary Supplement: L-carnitine 1000 mg twice daily
* Behavioral: Weekly health coaching calls
* Dietary Supplement: Placebo capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-carnitine<br>Oral L-carnitine 1000mg twice daily | Dietary Supplement: L-carnitine 1000 mg twice daily<br>* Oral L-carnitine to be taken twice daily for 8 weeks<br>|
| Experimental: L-carnitine + health coaching<br>Oral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls | Dietary Supplement: L-carnitine 1000 mg twice daily<br>* Oral L-carnitine to be taken twice daily for 8 weeks<br>Behavioral: Weekly health coaching calls<br>* Weekly health coaching calls lasting 10-15 minutes<br>|
| Placebo Comparator: Placebo<br>Placebo capsules twice daily | Dietary Supplement: Placebo capsules<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT) | 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. | baseline, end of 8 week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ) | 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. | baseline, end of 8 week intervention | 
| Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11) | 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. | baseline, end of 8 week intervention | 
| Physical Activity as Measured by the SenseWear Armband | 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. | end of 8 week intervention |