SarcoImage: Anatomical and Physiological Validation by Magnetic Resonance Imaging Biomarkers of the Effects of High Intensity Strenght Training and Myofascial Self-conditioning on Sarcopenia in Frail and Prefrail Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Muscle volume
研究概览
简要总结
The aim is quantify, correlate and establish the diagnostic and prognostic value of the variation of the image biomarkers obtained by magnetic resonance (muscle volume, morphological, biochemical and structural biomarkers) longitudinally in fragile or pre-frail elders with sarcopenia after a mixed physical training of strength and myofascial self-conditioning. This project is based on an, longitudinal, prospective, controlled, randomized, intervention study and blind for the researchers responsible for the study. 60 elderly with sarcopenia and frailty (Intervention Group, n=30; Control Group, n=30) will participate in the study. Intervention Group participants will perform 6-months mixed exercise program consisting in high-intensity strength training and self-myofascial conditioning. Data will be take trough 2 measurements that will be take place at baseline and post-intervention. Criteria of frailty, criteria of sarcopenia, sociodemographic, clinics, kinanthropometric, functional, nutritional and confusing variables will be evaluated. Moreover, magnetic resonance images will be performed to obtain muscle volume, morphological, biochemical and structural biomarkers.
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 (Investigator, Outcomes Assessor)
盲法说明
Investigator: The persons who make the data analysis and decide whether a patient has experienced an outcome of interest will be masked.
Outcome assessors: The persons who assess patients and provide outcome data will be masked.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders,
- •aged 70 years old or more,
- •with habitual residence in Valencia,
- •with independent wandering (they can have technical aids, but not from someone else)
- •that meets Fried's pre-frailty or frailty criteria
- •EGWSOP's sarcopenia criteria
- •who has agreed to participate in the study and signed the informed consent
排除标准
- •Patients with life expectancy less than six months
- •Institutionalized patients
- •Patients with severe visual or auditory deficits
- •Patients with contraindication in the performance of physical exercise (cardiovascular risk factors)
- •Patients with contraindications for the magnetic resonance study, especially carriers of non-compatible pacemakers, neurostimulators, cochlear implants and intracranial aneurysm clamping.
- •Patients with severe psychiatric illness or moderate or severe cognitive impairment.
- •Patients who refuse to sign the informed consent.
研究组 & 干预措施
Control Group
They will follow their daily routine without added exercise
Intervention Group
They will perform the mixed exercise program
干预措施: Mixed exercise program (Other)
结局指标
主要结局
Muscle volume
时间窗: 6 months
Changes related to macroscopic changes in muscle tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically muscle volume of the thigh by compartment - anterior, medial and posterior (in ml)
Microscopic fat fraction
时间窗: 6 months
Changes related to microscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically microscopic fat fraction (in %)
Descriptors of muscle texture
时间窗: 6 months
Changes related to microscopic changes in muscle tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically statistical descriptors of muscle texture: energy, entropy, contrast and homogeneity (adimensional)
Diffusion coefficient
时间窗: 6 months
Changes related to microscopic changes in diffusion coefficient assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically diffusion coefficient and apparent diffusion coefficient (mm2/s)
Bone volume
时间窗: 6 months
Changes related to macroscopic changes in bone tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically relative volume of bone (in %)
Relative volume of intramuscular fat
时间窗: 6 months
Changes related to macroscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically relative volume of intramuscular fat (in %)
Extramuscular subcutaneous fat
时间窗: 6 months
Changes related to macroscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically extramuscular subcutaneous fat (in ml)
次要结局
- Functional and physical performance(6 months)
- Forced spirometry(6 months)
- Lean mass(6 months)
- Activities of daily living(6 months)
- Body muscle mass(6 months)
- Handgrip strength(6 months)
- Walking speed(6 months)
- Fat mass(6 months)
- Articular range(6 months)
- Perceived quality of life(6 months)
- Type of drugs used(6 months)
- Body mass index(6 months)
- Body perimeters(6 months)
- Perceived pain(6 months)
- Respiratory muscles strength(6 months)
研究者
Francisco Martínez Arnau
Martínez-Arnau FM, PT, PhD
University of Valencia