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

Phase 2

• Conditions: Carnitine; Muscle; Old Age; Debility; Functional Status
• Interventions: Drug: L Carnitine; Behavioral: Supervised exercise; Behavioral: Exercise at home; Drug: Placebos

• Registration Number: NCT03180424
• Lead Sponsor: Hospital de Clínicas Dr. Manuel Quintela

Brief 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.

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-05-31
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-06
• Last Update Submitted: 2017-06-06
• Study First Posted: 2017-06-08
• Last Update Posted: 2017-06-08
• Primary Completion: 2017-08-31
• Study Completion: 2017-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L Carnitine + supervised exercise	L Carnitine	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 + supervised exercise	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 + Exercise at home	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.
Placebos + supervised exercise	Supervised exercise	Patients receiving placebo and supervised exercise plan.
L Carnitine + Exercise at home	L Carnitine	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.
Placebos + supervised exercise	Placebos	Patients receiving placebo and supervised exercise plan.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in the expression of fragility criteria	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.

Trial Locations

Locations (1)

Hospital de Clinicas Dr. Manuel Quintela; 🇺🇾 Montevideo, Uruguay