SarcopeniaNCT07013604
Sarcopenia and Intervention Physical Therapy
A study testing Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group in people with Sarcopenia, run by Pharos University in Alexandria.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older age (≥ 60-75 years)
- Low muscle strength (e.g., low handgrip strength)
- Low muscle mass (e.g., ASM/height² below cutoff)
Who cannot join
- heart disese
- kidny disese
- autoimune disese
- cognetive disorder
- sever form of sarcopenia
About this study
Official title: Effectiveness of Neuromuscular Electrical Stimulation Versus Low-load Resistance Training With Blood Flow Restriction in Elderly Individuals With Sarcopenia
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
Read the 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
- Conditions
- Sarcopenia
- Being tested
- Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR GroupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 month
Secondary outcomes (2)
Muscle Strength Handheld dynamometer (e.g., MicroFET)
Isometric knee extension strength
Measurement: Pre- and post-intervention, using the highest or average value from 2-3 trials.
Measured: 2 month
Timed Up and Go (TUG) Test
Assesses eight domains of health-related quality of life, scored from 0 to 100. Administered before and after the intervention period
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start10 Jun 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Elsayed Elgohary, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013604
- Sponsor's protocol ID
- sarcopenia
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neuromuscular Electrical Stimulation Versus Low-load Resistance Training With Blood Flow Restriction in Elderly Individuals With Sarcopenia
- ClinicalTrials.gov ID
- NCT07013604
- Acronym / sponsor ID
- sarcopenia
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) Group | Experimental | Device: Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR GroupParticipants receive neuromuscular electrical stimulation (NMES) targeting the quadriceps and hamstrings, 30 minutes per session, 3 times per week for 8 weeks |
| Resistance + BFR Group | Experimental | Device: Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR GroupParticipants 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 |
| Control Group | Placebo comparator | Device: Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR GroupParticipants 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 |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older age (≥ 60-75 years)
- Low muscle strength (e.g., low handgrip strength)
- Low muscle mass (e.g., ASM/height² below cutoff)
Key exclusion criteria (5 listed)
- heart disese
- kidny disese
- autoimune disese
- cognetive disorder
- sever form of sarcopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR GroupNMES 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. | Device | Control Group, Neuromuscular Electrical Stimulation (NMES) Group, Resistance + BFR Group |
Primary outcome
Change in Muscle Mass
Time frame: 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
2 secondary outcomes
Muscle Strength Handheld dynamometer (e.g., MicroFET)
Time frame: 2 month
Timed Up and Go (TUG) Test
Time frame: 2 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation (NMES) Group,Resistance + BFR Group in people with Sarcopenia, run by Pharos University in Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Mass (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.