跳至主要内容
临床试验/NCT07013604
NCT07013604尚未招募不适用

Effectiveness of Neuromuscular Electrical Stimulation Versus Low-load Resistance Training With Blood Flow Restriction in Elderly Individuals With Sarcopenia

Pharos University in Alexandria0 个研究点目标入组 60 人开始时间: 2025年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Change in Muscle Mass

研究概览

简要总结

To evaluate and compare the effectiveness of neuromuscular electrical stimulation (NMES) and low-load resistance training with blood flow restriction (BFR) in improving muscle mass, strength, functional performance, and quality of life in elderly individuals diagnosed with sarcopenia

详细描述

Sarcopenia, the age-related decline in muscle mass, strength, and function, significantly affects the health and independence of elderly individuals. It increases the risk of frailty, falls, and disability. Neuromuscular electrical stimulation (NMES) and low-load resistance training with blood flow restriction (BFR) are promising rehabilitation strategies for older adults with limited physical capacity. This study aims to compare the effectiveness of NMES and BFR in managing sarcopenia and improving physical and functional outcomes in the elderly

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

This study uses single-blind masking. While participants are aware of their group assignment due to the nature of the interventions (especially NMES and resistance training), outcome assessors who perform the post-intervention evaluations (e.g., muscle strength, functional performance, and quality of life) will be blinded to group allocation. This is done to reduce assessment bias and ensure objective measurement of outcomes.

Additionally, the control group receives a placebo treatment (being connected to a non-active neuromusculoskeletal device), which helps reduce the psychological effects of knowing they are not receiving active intervention

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Older age (≥ 60-75 years)
  • •Low muscle strength (e.g., low handgrip strength)
  • •Low muscle mass (e.g., ASM/height² below cutoff)

排除标准

  • •heart disese
  • •kidny disese
  • •autoimune disese
  • •cognetive disorder
  • •sever form of sarcopenia

研究组 & 干预措施

Control Group

Placebo Comparator

Participants receive placebo treatment by being connected to a neuromusculoskeletal device that is turned off (no actual stimulation), with no active intervention during the 8-week period

干预措施: Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group (Device)

Neuromuscular Electrical Stimulation (NMES) Group

Experimental

Participants receive neuromuscular electrical stimulation (NMES) targeting the quadriceps and hamstrings, 30 minutes per session, 3 times per week for 8 weeks

干预措施: Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group (Device)

Resistance + BFR Group

Experimental

Participants perform low-load resistance training (30% 1RM) combined with blood flow restriction using pneumatic cuffs, 30 minutes per session, 3 times per week for 8 weeks

干预措施: Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group (Device)

结局指标

主要结局

Change in Muscle Mass

时间窗: 2 month

Assessed using Bioelectrical Impedance Analysis (BIA) to measure skeletal muscle mass. Evaluation is done pre- and post-intervention to detect changes in the Skeletal Muscle Index (SMI), based on EWGSOP2 criteria

次要结局

  • Muscle Strength Handheld dynamometer (e.g., MicroFET)(2 month)
  • Timed Up and Go (TUG) Test(2 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ola Mohamed Elsayed Elgohary

ola mohamed elsayed elgohary

Pharos University in Alexandria

相似试验