Back to resultsL-carnitine for Fatigue in COPD (LC4COPD)
Primary Purpose
Copd, Fatigue
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
L-carnitine 1000 mg twice daily
Weekly health coaching calls
Placebo capsules
Sponsored by
About this trial
This is an interventional treatment trial for Copd
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
L-carnitine
L-carnitine + health coaching
Placebo
Arm Description
Oral L-carnitine 1000mg twice daily
Oral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls
Placebo capsules twice daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03008356
Brief Title
L-carnitine for Fatigue in COPD
Acronym
LC4COPD
Official Title
L-Carnitine Supplementation With and Without Health Coaching for Fatigue in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-carnitine
Arm Type
Experimental
Arm Description
Oral L-carnitine 1000mg twice daily
Arm Title
L-carnitine + health coaching
Arm Type
Experimental
Arm Description
Oral L-carnitine 1000mg twice daily and weekly 10-15 minute health coaching calls
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
L-carnitine 1000 mg twice daily
Intervention Description
Oral L-carnitine to be taken twice daily for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Weekly health coaching calls
Intervention Description
Weekly health coaching calls lasting 10-15 minutes
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo capsules
Primary Outcome Measure Information:
Title
Change in Exercise Capacity as Measured by the Six Minute Walk Test (6MWT)
Description
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
Secondary Outcome Measure Information:
Title
Change in Health-Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ)
Description
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
Title
Change in Physical Fatigue as Measured by the Chalder Fatigue Questionnaire (CFQ-11)
Description
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
baseline, end of 8 week intervention
Title
Physical Activity as Measured by the SenseWear Armband
Description
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.
Time Frame
end of 8 week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto P Benzo
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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L-carnitine for Fatigue in COPD
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