Impact on Functional Status in Older Adults Treated With L-Carnitine
NCT ID: NCT03180424
Last Updated: 2017-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2017-01-01
2017-09-30
Brief Summary
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Detailed Description
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Circulating L-carnitine levels increase after administration of the supplement. The impact on the function of L-carnitine in combination with physical exercise will be studied in a population of older adults in Montevideo.
The sample will be divided into 3 groups, according to the intervention:
Group 1: Patients who will receive L-Carnitine in addition to a manual to perform physical exercise at home.
Group 2: Patients receiving L-Carnitine plus supervised exercise plan. Group 3: Patients receiving placebo and supervised exercise plan. All three groups will be evaluated for functional and anthropometric parameters: prior, during and after intervention. In addition, the dosage of L-carnitine and acetylcarnitine will be evaluated before and after the intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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L Carnitine + Exercise at home
Patients who will receive L Carnitine, in liquid form, at a dosage of 2g per day, in a single intake, in addition to physical exercise advice at home for which a manual will be delivered in the consultation, for 12 weeks.
L Carnitine
L Carnitine liquid, single daily dose of 2g orally.
Exercise at home
A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision
L Carnitine + supervised exercise
Patients receiving L Carnitine, in liquid form, at doses of 2g per day, in a single intake, in addition to a supervised physical exercise plan, for 12 weeks.
L Carnitine
L Carnitine liquid, single daily dose of 2g orally.
Supervised exercise
Modified Otago exercise programme, 2 times a week with a duration of 45 minutes, to be supervised by a previously qualified and trained instructor. Follow up of the established plan includes an adequate monitoring, evaluating the evolution and the possible adverse effects that may appear.
Placebos + supervised exercise
Patients receiving placebo and supervised exercise plan.
Supervised exercise
Modified Otago exercise programme, 2 times a week with a duration of 45 minutes, to be supervised by a previously qualified and trained instructor. Follow up of the established plan includes an adequate monitoring, evaluating the evolution and the possible adverse effects that may appear.
Placebos
Liquid substance, similar to the one containing L carnitine, in the same presentation
Interventions
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L Carnitine
L Carnitine liquid, single daily dose of 2g orally.
Supervised exercise
Modified Otago exercise programme, 2 times a week with a duration of 45 minutes, to be supervised by a previously qualified and trained instructor. Follow up of the established plan includes an adequate monitoring, evaluating the evolution and the possible adverse effects that may appear.
Placebos
Liquid substance, similar to the one containing L carnitine, in the same presentation
Exercise at home
A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision
Eligibility Criteria
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Inclusion Criteria
* Ability to comply with aerobic physical activity of moderate intensity and basic resistance.
* Not depressed patients (Yesavage \<5 in patients without previous depression or Hamilton \<7 in patients in treatment for depression)
* MMSE (Mini-Mental State Examination) greater than 24 points.
* Independent or mildly dependent patients, Barthel\> 95 points.
* Patients without visual disturbances or with decreased visual acuity corrected.
* No pain or with VAS (Visual analogue scale) \<3/10.
* Patients without nutritional risk, MNA (Mini Nutritional Assessment \> 23.5 / 30 points) and BMI (Body Mass Index) \> 23 kg / m2.
Exclusion Criteria
* Patients with osteoarticular pathology that limits their physical activity.
* Previous neurological pathology (Stroke, Enf. Of Parkinson's).
* Acute or chronic diseases decompensated or with lymphedema that makes difficult the accomplishment of the bioimpedanciometry.
* Patients using orthopedic devices and prostheses or pacemakers that interfere with gait or impede the achievement of bioimpedanciometry.
* BMI less than 23 and / or an involuntary weight loss of 3kg or more in the last 3 months.
* Psychiatric disorders that hinder adherence to treatment.
* Moderate to severe Chronic Renal Disease
* Patient who does not agree to participate in the study.
65 Years
ALL
Yes
Sponsors
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University of the Republic, Uruguay
OTHER
Hospital de Clínicas Dr. Manuel Quintela
OTHER
Responsible Party
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Ana Barboza
Principal Investigator
Principal Investigators
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Aldo Sgaravatti, MD
Role: STUDY_DIRECTOR
HospítalCDMQ
Locations
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Hospital de Clinicas Dr. Manuel Quintela
Montevideo, , Uruguay
Countries
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Other Identifiers
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Protocolo L-Carnitina
Identifier Type: -
Identifier Source: org_study_id
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