Impact on Functional Status in Older Adults Treated With L-Carnitine
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in elderly's function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/
- •Patients without nutritional risk, MNA (Mini Nutritional Assessment > 23.5 / 30 points) and BMI (Body Mass Index) > 23 kg / m2.
排除标准
- •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.
研究组 & 干预措施
L Carnitine + 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.
干预措施: L Carnitine (Drug)
L Carnitine + 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.
干预措施: Exercise at home (Behavioral)
L Carnitine + 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.
干预措施: L Carnitine (Drug)
L Carnitine + 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.
干预措施: Supervised exercise (Behavioral)
Placebos + supervised exercise
Patients receiving placebo and supervised exercise plan.
干预措施: Supervised exercise (Behavioral)
Placebos + supervised exercise
Patients receiving placebo and supervised exercise plan.
干预措施: Placebos (Drug)
结局指标
主要结局
Changes in elderly's function
时间窗: 12 weeks
Independence Scales for Activities of Daily Living
Gait speed
时间窗: 12 weeks
Gait speed measured after the intervention
Elderly's physical performance
时间窗: 12 weeks
Elderly's physical performance assessed by SPPB (Short Physical Performance Battery Protocol).
次要结局
- Changes in the expression of fragility criteria(12 weeks)
研究者
Ana Barboza
Principal Investigator
Hospital de Clínicas Dr. Manuel Quintela