Impact on Functional Status in Older Adults Treated With L-Carnitine

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 31, 2017

Detailed Description

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.

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

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Experimental: 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.
  • Placebo Comparator: Placebos + supervised exercise
    • Patients receiving placebo and supervised exercise plan.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in elderly’s function
    • Time Frame: 12 weeks
    • Independence Scales for Activities of Daily Living
  • Gait speed
    • Time Frame: 12 weeks
    • Gait speed measured after the intervention
  • Elderly’s physical performance
    • Time Frame: 12 weeks
    • Elderly’s physical performance assessed by SPPB (Short Physical Performance Battery Protocol).

Secondary Measures

  • Changes in the expression of fragility criteria
    • Time Frame: 12 weeks
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who meet at least 2 criteria for the fragility phenotype of Linda Fried – 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:
  • Absolute contraindications for performing physical exercise: recent AMI or unstable angina, uncontrolled hypertension, acute HF and complete AV block. – 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.
  • Gender Eligibility: All

    Minimum Age: 65 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Hospital de Clínicas Dr. Manuel Quintela
    • Collaborator
      • University of the Republic, Uruguay
    • Provider of Information About this Clinical Study
      • Principal Investigator: Ana Barboza, Principal Investigator – Hospital de Clínicas Dr. Manuel Quintela
    • Overall Official(s)
      • Aldo Sgaravatti, MD, Study Director, HospítalCDMQ

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