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

Hospital de Clínicas Dr. Manuel Quintela

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Carnitine; Muscle; Functional Status; Old Age; Debility

Treatments: Behavioral: Supervised exercise; Drug: L Carnitine; Behavioral: Exercise at home; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03180424

Protocolo L-Carnitina

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

L Carnitine + Exercise at home

Active Comparator group

Description:

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.

Treatment:

Drug: L Carnitine

Behavioral: Exercise at home

L Carnitine + supervised exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Supervised exercise

Drug: L Carnitine

Placebos + supervised exercise

Placebo Comparator group

Description:

Patients receiving placebo and supervised exercise plan.

Treatment:

Behavioral: Supervised exercise

Drug: Placebos