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

Old Age; Debility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03180424
• Other study ID #: Protocolo L-Carnitina
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: May 31, 2017
• Last updated: June 6, 2017
• Start date: January 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: June 2017
• Source: Hospital de Clínicas Dr. Manuel Quintela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: September 30, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carnitine; Muscle
• Functional Status
• Old Age; Debility

Intervention

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

Locations

Country	Name	City	State
Uruguay	Hospital de Clinicas Dr. Manuel Quintela	Montevideo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clínicas Dr. Manuel Quintela	University of the Republic, Uruguay

Country where clinical trial is conducted

Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Determine levels of ammonia in blood	Determine levels of ammonia in blood in the study population before and after L carnitine supplementation.	12 weeks
Primary	Changes in elderly's function	Independence Scales for Activities of Daily Living	12 weeks
Primary	Gait speed	Gait speed measured after the intervention	12 weeks
Primary	Elderly's physical performance	Elderly's physical performance assessed by SPPB (Short Physical Performance Battery Protocol).	12 weeks
Secondary	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