Sarcopenia and Intervention Physical Therapy

NCT ID: NCT07013604

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2025-09-01

Brief Summary

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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

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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

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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

Study Groups

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Neuromuscular Electrical Stimulation (NMES) Group

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Resistance + BFR Group

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

Group Type EXPERIMENTAL

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

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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.

Interventions

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Neuromuscular 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pharos University in Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Ola Mohamed Elsayed Elgohary

ola mohamed elsayed elgohary

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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sarcopenia

Identifier Type: -

Identifier Source: org_study_id

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