Impact on Functional Status in Older Adults Treated With L-Carnitine
NCT03180424 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2017-06-08
Summary
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.
Conditions
- Carnitine; Muscle
- Functional Status
- Old Age; Debility
Interventions
- DRUG
-
L Carnitine
L Carnitine liquid, single daily dose of 2g orally.
- BEHAVIORAL
-
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.
- DRUG
-
Placebos
Liquid substance, similar to the one containing L carnitine, in the same presentation
- BEHAVIORAL
-
Exercise at home
A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision
Sponsors & Collaborators
-
University of the Republic, Uruguay
collaborator OTHER -
Hospital de Clínicas Dr. Manuel Quintela
lead OTHER
Principal Investigators
-
Aldo Sgaravatti, MD · HospítalCDMQ
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-01-01
- Primary Completion
- 2017-08-31
- Completion
- 2017-09-30
- FDA Drug
- Yes
Countries
- Uruguay
Study Locations
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