Sarcopenia and Intervention Physical Therapy

NCT07013604 | Not Yet Recruiting

• 1 other identifier: sarcopenia
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Change in Muscle Mass

  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

  2 month

Secondary Outcomes (2)

• Muscle Strength Handheld dynamometer (e.g., MicroFET)

  2 month

• Timed Up and Go (TUG) Test

  2 month

Study Arms (3)

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

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

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

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

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

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

Interventions

Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group DEVICE

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.

Control Group; Neuromuscular Electrical Stimulation (NMES) Group; Resistance + BFR Group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pharos University in Alexandria: lead

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ola mohamed elsayed elgohary

Model Details: 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).

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 10, 2025
• Study Start: June 10, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-05