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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03180424
• Date of registration: 31/05/2017
• Prospective Registration: No
• Primary sponsor: Hospital de Clínicas Dr. Manuel Quintela
• Public title: Impact on Functional Status in Older Adults Treated With L-Carnitine
• Scientific title: Impact on Functional Status in Older Adults Treated With L-Carnitine
• Date of first enrolment: January 1, 2017
• Target sample size: 60
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT03180424
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Uruguay

Contacts

• Name: Aldo Sgaravatti, MD
• Affiliation: HospítalCDMQ

Key inclusion & exclusion criteria

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.



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Old Age; Debility

Carnitine; Muscle

Functional Status

Intervention(s)

Drug: L Carnitine

Behavioral: Exercise at home

Behavioral: Supervised exercise

Drug: Placebos

Primary Outcome(s)

Elderly's physical performance [Time Frame: 12 weeks]

Gait speed [Time Frame: 12 weeks]

Changes in elderly's function [Time Frame: 12 weeks]

Secondary Outcome(s)

Changes in the expression of fragility criteria [Time Frame: 12 weeks]

Secondary ID(s)

Protocolo L-Carnitina

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of the Republic, Uruguay