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

NCT03180424 | Unknown Phase 2 FDA Drug

• 1 other identifier: Protocolo L-Carnitina
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carnitine; Muscle; Functional Status; Old Age; Debility

Keywords

carnitine; elderly; functional status

Outcome Measures

Primary Outcomes (3)

• Changes in elderly's function

  Independence Scales for Activities of Daily Living

  12 weeks

• Gait speed

  Gait speed measured after the intervention

  12 weeks

• Elderly's physical performance

  Elderly's physical performance assessed by SPPB (Short Physical Performance Battery Protocol).

  12 weeks

Secondary Outcomes (1)

• Changes in the expression of fragility criteria

  12 weeks

Other Outcomes (2)

• Determine blood levels of L carnitine and acetylcarnitine

  12 weeks

• Determine levels of ammonia in blood

  12 weeks

Study Arms (3)

L Carnitine + Exercise at home

ACTIVE COMPARATOR

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.

Drug: L Carnitine; Behavioral: Exercise at home

L Carnitine + supervised exercise

EXPERIMENTAL

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.

Drug: L Carnitine; Behavioral: Supervised exercise

Placebos + supervised exercise

PLACEBO COMPARATOR

Patients receiving placebo and supervised exercise plan.

Behavioral: Supervised exercise; Drug: Placebos

Interventions

L Carnitine DRUG

L Carnitine liquid, single daily dose of 2g orally.

L Carnitine + Exercise at home; L Carnitine + supervised exercise

Supervised exercise BEHAVIORAL

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.

L Carnitine + supervised exercise; Placebos + supervised exercise

Placebos DRUG

Liquid substance, similar to the one containing L carnitine, in the same presentation

Placebos + supervised exercise

Exercise at home BEHAVIORAL

A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision

L Carnitine + Exercise at home

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clínicas Dr. Manuel Quintela: lead
• University of the Republic, Uruguay: collaborator

Study Sites (1)

Hospital de Clinicas Dr. Manuel Quintela

Montevideo, 11600, Uruguay

Location

MeSH Terms

Conditions

Frailty

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Aldo Sgaravatti, MD

  HospítalCDMQ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 8, 2017
• Study Start: January 1, 2017
• Primary Completion: August 31, 2017
• Study Completion: September 30, 2017
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

UR (1)