Sarcopenia
Conditions
Brief summary
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
Detailed description
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
Interventions
DEVICENeuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group
NMES Group: Receives neuromuscular electrical stimulation to the thigh muscles for 30 minutes, three times per week, over 8 weeks. Resistance + BFR Group: Performs low-load resistance exercises with blood flow restriction applied to the thighs, also for 30 minutes per session, three times per week, over 8 weeks. Control Group: Receives placebo treatment using a turned-off stimulation device with no active intervention during the 8-week period.
Sponsors
Pharos University in Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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
Intervention model description
This study follows a randomised controlled trial (RCT) design involving 60 elderly participants aged 60-75 years diagnosed with sarcopenia according to EWGSOP2 criteria. Participants will be randomly assigned to three groups (n = 20 each).
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Older age (≥ 60-75 years) Low muscle strength (e.g., low handgrip strength) Low muscle mass (e.g., ASM/height² below cutoff)
Exclusion criteria
* heart disese * kidny disese * autoimune disese * cognetive disorder * sever form of sarcopenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Mass | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength Handheld dynamometer (e.g., MicroFET) | 2 month | Isometric knee extension strength Measurement: Pre- and post-intervention, using the highest or average value from 2-3 trials. |
| Timed Up and Go (TUG) Test | 2 month | Assesses eight domains of health-related quality of life, scored from 0 to 100. Administered before and after the intervention period |
Outcome results
None listed