Multicomponent Analysis of phYsical Frailty BiomarkErs: Focus on Mitochondrial Health - MAYBE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Change from baseline 1-repetition maximum with isokinetic dynamometer at 5-months
研究概览
简要总结
The study will be conducted in a group of obese sarcopenic patients (Sarco-Ob) aged > 60 years on moderately hypocaloric diet therapy aimed at comparing the effect of a strength exercise protocol, combined or not with dietary supplementation with amino acids, on physical performance, muscle strength, body composition, muscle oxidative metabolism, and biomarkers of sarcopenia. The supplementation study will be conducted in a double-blind manner.
详细描述
In this double-blind randomised control trial, older men, and women resident in Verona (Italy) will be selected from the Geriatrics Nutritional Clinic of the Borgo Trento Hospital or were contacted by telephone. A specific medical screening was initially programmed to verify the criteria of recruitment.
Anthropometric and body composition In the morning, in a fasted state, body mass will be taken with an electronic scale (Tanita electronic scale BWB-800 MA) and stature will be measured with a Harpenden stadiometer (Holtain Ltd., Crymych, Pembs. UK); BMI will be calculated as weight (kg)/height (m)2. Thereafter, total and regional body composition will be evaluated by means of dual-energy X-ray absorptiometry (DXA) using a total body scanner (QDR Horizon W, Hologic, MA, USA; fan-bean technology, software for Windows XP version 12.4.2) according to the manufacturer's procedures. Furthermore, the ALMI will be calculated as the sum of lean mass of arms and legs divided by height squared.
Physical performance On the same day, the SPPB test will be used to assess functional performance of the lower extremities. Each participant will performed: 4 m at usual customary gait speed, a five repeated chair-stands test and three standing balance tests (side by side, semi-tandem and tandem).
A digital dynamometer (CAMRY, Digital Hand Dynamometer model: EH101) will be used to assess HGS and all measurements were conducted by the same operator. Before starting, participants will observe a demonstration of the test procedure and engage in two practice attempts.
Knee muscle strength measurements and analysis An isokinetic dynamometer (CMSi Cybex Humac Norm Dynamometer, Lumex, Ronkokoma, NY, USA) will be used to assess the isokinetic strength of knee flexors and extensors muscles.
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)
盲法说明
Double blind
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be included in the study based on the following inclusion criteria:
- •Older men and women between 60-80 years
- •The presence of sarcopenic obesity was considered when the following two conditions were satisfied: Fat mass > 34.8% and FFM <90% of subject's ideal FFM.
- •Resident in Verona (Italy)
- •Stable weight in the previous 2 months
- •Previously sedentary (less than one hour of exercise per week in the last 6 months)
- •Signing of the informed consent for participation in the study
- •Exclusion criteria:
- •Unstable angina or recent myocardial infarction
- •Malignant or unstable arrhythmias
- •Heart failure NYHA class > II
- •Severe respiratory failure
- •Severe heart valve disease (i.e severe aortic stenosis or insufficiency)
- •Abdominal and/or thoracic aneurysm
- •Recent intracerebral or subdural haemorrhage
- •Poorly controlled arterial hypertension
- •Presence of pacemakers or metal prostheses
- •Severe chronic renal failure
- •Symptomatic musculoskeletal pathology
- •Symptomatic disc herniation, arthrosis, acute joint, tendon and ligamentous injuries, hip and/or knee prostheses recently placed (<6 months) or with joint instability, symptomatic or large inguinal or abdominal hernia
- •Acute retinal detachment or bleeding
- •Recent eye surgery (laser, cataract, retinal surgery, glaucoma surgery)
- •History of malignant cancer within the previous 5 years
- •Diagnosis of dementia
- •Eating disorders
排除标准
- 未提供
结局指标
主要结局
Change from baseline 1-repetition maximum with isokinetic dynamometer at 5-months
时间窗: Month0, Month5
Change in 1-repetition maximum test performed with isokinetic dynamometer in Kilograms
次要结局
- Changesfrom baseline skeletal muscle mass at 5-months(Month0, Month5)
- Change from baseline fat mass at 5-months(Month0, Month5)
- Change from baseline in muscle power at 5-months(Month0, Month5)
- Change from baseline Short Physical Performance Battery at 5-months(Month0, Month 5)
- Change from baseline in handgrip at 5-months(Month0, Month5)
- Change from baseline in mRNA at 5-months(Month0, Month5)