Clinical trial NCT03180424: Impact on Functional Status in Older Adults Treated With L-Carnitine
Official title: Impact on Functional Status in Older Adults Treated With L-Carnitine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Carnitine; Muscle
Functional Status
Old Age; Debility
Keywords: carnitine
elderly
functional status
Lead sponsor: Hospital de Clínicas Dr. Manuel Quintela
Sponsor class: OTHER
Collaborators: name: University of the Republic, Uruguay
First posted: 2017-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes in elderly's function
timeFrame: 12 weeks
measure: Gait speed
timeFrame: 12 weeks
measure: Elderly's physical performance
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in the expression of fragility criteria
timeFrame: 12 weeks
Other outcomes:
measure: Determine blood levels of L carnitine and acetylcarnitine
timeFrame: 12 weeks
measure: Determine levels of ammonia in blood
timeFrame: 12 weeks
Locations:
city: Montevideo
country: Uruguay
facility: Hospital de Clinicas Dr. Manuel Quintela
Study officials:
affiliation: HospítalCDMQ
name: Aldo Sgaravatti, MD
role: STUDY_DIRECTOR
References: