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| Name | Class |
|---|---|
| University of the Republic, Uruguay | OTHER |
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This study evaluates the impact of the treatment with L-Carnitine on the function of adults over 65 years, in conjunction with regular exercise. Simple randomization will be performed, distributing patients in 3 treatment groups, with L-Carnitine or Placebo, and with physical exercise at home or supervised.
The supplemental intake of L-carnitine improves the physical functioning of the pre-fragile and fragile elder of the community.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L Carnitine + Exercise at home | Active Comparator | 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. |
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| L Carnitine + supervised exercise | Experimental | 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. |
|
| Placebos + supervised exercise | Placebo Comparator | Patients receiving placebo and supervised exercise plan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L Carnitine | Drug | L Carnitine liquid, single daily dose of 2g orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in elderly's function | Independence Scales for Activities of Daily Living | 12 weeks |
| Gait speed | Gait speed measured after the intervention | 12 weeks |
| Elderly's physical performance | Elderly's physical performance assessed by SPPB (Short Physical Performance Battery Protocol). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the expression of fragility criteria | The Fragility criteria will be measured according to criteria promulgated and validated by Fried. The 5 original criteria will be used, but some measures to characterize the fragility will be adapted to the modifications of Avila-Funes. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determine blood levels of L carnitine and acetylcarnitine | Determine L-Carnitine and Acetylcarnitine levels in the study population before and after L carnitine supplementation. | 12 weeks |
| Determine levels of ammonia in blood |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aldo Sgaravatti, MD | HospÃtalCDMQ | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas Dr. Manuel Quintela | Montevideo | 11600 | Uruguay |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Supervised exercise | Behavioral | 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. |
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| Placebos | Drug | Liquid substance, similar to the one containing L carnitine, in the same presentation |
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| Exercise at home | Behavioral | A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision |
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Determine levels of ammonia in blood in the study population before and after L carnitine supplementation.
| 12 weeks |