Neuromuscular Electrical StimulationNCT07076797
Effects of Lower Extremity Functional Exercise Program and Neuromuscular Electrical Nerve Stimulation in Older Adults
A study testing EXERCISE TRAINING and NMES in people with Neuromuscular Electrical Stimulation, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate and compare the effects of lower extremity functional exercise program and neuromuscular electrical nerve stimulation on muscle thickness, muscle strength, gait and fall risk in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Electrical Stimulation
- What is being tested?
- EXERCISE TRAINING and NMES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Relatively healthy older women aged 65-84 years
- Individuals without neurological, orthopedic, systemic (cardiovascular) problems that would prevent them from performing the test
- To have a score of 6 and above on the Hodkinson Abbreviated Mental Test
- At least 90 points on the Barthel activities of daily living test
- Ability to walk independently (with or without walking aids)
- Living in a nursing home or in their own home
Who cannot join
- Having a defined neurological (including vertigo), orthopedic, orthopedic, psychiatric, systemic (cardiovascular, cachectic due to malnutrition) disease that prevents walking and mobility
- Being in the statin drug group
- Diagnosis of sarcopenia
- Having communication problems
- Visual impairment (severe) or hearing impairment (severe)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences in Biruni University
Istanbul, ZEYTINBURNU, 34010
About this study
Official title: The Effects of Lower Extremity Functional Exercise Program and Neuromuscular Electrical Nerve Stimulation on Muscle Strength, Muscle Thickness, Gait and Fall Risk in the Elderly
The aim of this study was to investigate and compare the effects of lower extremity functional exercise program and neuromuscular electrical nerve stimulation on muscle thickness, muscle strength, gait and fall risk in the elderly.
Read the detailed description
Study Design: It will be a randomized, controlled study. The participants to be included in the study will be divided into two groups using the random randomization method. In this method; participants will be included in the study.
- Conditions
- Neuromuscular Electrical Stimulation
- Being tested
- EXERCISE TRAINING, NMES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAININGOther
PHYSIOTHERAPY PROGRAM
NMESOther
PHYSIOTHERAPY PROGRAM
| Study group | Role | What they receive |
|---|---|---|
| Group 1-NMES | Experimental | experimental group will receive neuromuscular electrical stimulation only Receives: Other: NMES |
| Group 2-EXERCISE | Active comparator | acticve comparator group will receive exercise training only Receives: Other: EXERCISE TRAINING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Imaging
Thickness measurements for both lower extremity quadriceps femoris muscle and tibialis anterior muscle will be evaluated. For resting muscle thickness, the person will be positioned in a supine position with the knee extended and the leg in neutral rotation (weights will be placed on the ankles to prevent external rotation laterally). The distance between the spina iliaca anterior superior and the upper border of the patella on the anterior thigh region will be measured with a tape measure, the probe will be placed transversely on the long axis of the thigh so that it is 1/3 of the distance close to the patella, and this area will be marked with a pencil. When evaluating the tibialis anterior muscle, the patient will be in the supine position at a point corresponding to 30% of the distance between the lateral tibial condyle and the lateral malleolus. Transmission gel will be used between the skin and the ultrasound head.
Measured: baseline and week 13
Assessment of Muscle Strength
Quadriceps and tibialis anterior muscle strength will be measured with digital handheld dynamometer. The digital muscle measurement device is a portable device with 3 interchangeable heads and a digital LCD screen. The device can provide data such as Peak power, time to reach peak power, total test time and average force in kg Newton and pounds. For the measurement of Quadriceps strength on both legs; the test will begin with the participants sitting on a flat surface with their hips and knees flexed at 90 degrees. The dynamometer will be placed perpendicular to the leg, 1-2 cm above the level of the malleoli. The "make test" technique, which requires isometric contraction, will be applied. All measurements will be taken twice from both legs of the participants by the same researcher with the same hand. For the Tibialis anterior strength measurement on both legs, the participant will be asked to dorsiflex their ankles while lying face down on a flat table.
Measured: bbaseline and week 13
Secondary outcomes (6)
10-Meter Walking Test
During the test, the patient will walk at a normal walking speed between two markers that are 10 meters apart and the elapsed time will be recorded. Measurements will be made twice and the best value will be recorded. The number of steps in a 10-meter distance during walking will also be recorded (Wade, 1992)
Measured: baseline and week 13
Dynamic Balance Test (Timed Up and Go Test)
The timed up and go test will be used. The test evaluates functional mobility, balance and performance in older adults. The patient, wearing normal shoes and conventional walking aids, begins the test in a standard chair with his back leaning, his arms resting on the arms of the chair and both feet flat on the floor. The patient is asked to stand up and walk to a line on the floor 3 meters away, turn on the line, walk back to the chair and sit on the chair (Shumway, 2000). The test ends when the patient's hip touches the chair. The test is repeated twice; the fastest time is recorded. <10 s of movement, >13.5 s means an increased risk of falling (Podsiadlo, 1991; Şahin, 2008).
Measured: baseline and week 13
Static Balance Test (One-Legged Standing Test)
One-Legged Standing Test The one-legged standing test (eyes open) will be used. One leg is lifted without touching the standing leg. The eyes remain open and the patient is asked to maintain their balance for 30 seconds (Stevenson, 1996). If the lifted leg touches the supporting leg, if the lifted leg touches the ground, the patient is asked to.
Measured: baseline and week 13
Sit-to-Stand Chair Test
İt will also be used to evaluate lower extremity muscle strength. The patient sits on a chair without arm support, the patient tries to do 5 sit-stands with a signal the person is allowed 2 attemps and the fastes score is recorded.
Measured: baseline and week 13
Assessment of Fall Risk
The Fullerton Balance Scale (FAB-T) will be used. It was developed to identify more subtle changes in multiple dimensions of balance.
Measured: baseline and week 13
Participant Satisfaction Assessment
a satisfaction assessment consisting of 0-10 points will be made for both groups before and after the intervention for elderly individuals. The two extreme definitons of the parameter to be evaluated 0 and 10 points. The patients written on both ends of a 100 mm line and will be asked to indicate where his/her situation is appropriate on this line by drawing a line putting a dut or pointing.
Measured: baseline and week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Oct 2025
- Primary completion10 Jan 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Electrical StimulationStudies 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
- Parallel groups
- Model description
- a randomized controlled study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ugur Cavlak, Biruni University
- Investigators
- UGUR CAVLAK, Prof., Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076797
- Sponsor's protocol ID
- BiruniUniversityIst
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cadore EL, Casas-Herrero A, Zambom-Ferraresi F, Idoate F, Millor N, Gomez M, Rodriguez-Manas L, Izquierdo M. Multicomponent exercises including muscle power training enhance muscle mass, power output, and functional outcomes in institutionalized frail nonagenarians. Age (Dordr). 2014 Apr;36(2):773-85. doi: 10.1007/s11357-013-9586-z. Epub 2013 Sep 13.
PubMed 24030238Sarabon N, Kozinc Z, Lofler S, Hofer C. Resistance Exercise, Electrical Muscle Stimulation, and Whole-Body Vibration in Older Adults: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Sep 8;9(9):2902. doi: 10.3390/jcm9092902.
PubMed 32911822
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lower Extremity Functional Exercise Program and Neuromuscular Electrical Nerve Stimulation on Muscle Strength, Muscle Thickness, Gait and Fall Risk in the Elderly
- ClinicalTrials.gov ID
- NCT07076797
- Acronym / sponsor ID
- BiruniUniversityIst
- Conditions
- Neuromuscular Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 22 Jul 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.
The aim of this study was to investigate and compare the effects of lower extremity functional exercise program and neuromuscular electrical nerve stimulation on muscle thickness, muscle strength, gait and fall risk in the elderly.
Detailed description
Study Design: It will be a randomized, controlled study. The participants to be included in the study will be divided into two groups using the random randomization method. In this method; participants will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Group 1-NMES | Experimental | Other: NMESexperimental group will receive neuromuscular electrical stimulation only |
| Group 2-EXERCISE | Active comparator | Other: EXERCISE TRAININGacticve comparator group will receive exercise training only |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Relatively healthy older women aged 65-84 years
- Individuals without neurological, orthopedic, systemic (cardiovascular) problems that would prevent them from performing the test
- To have a score of 6 and above on the Hodkinson Abbreviated Mental Test
- At least 90 points on the Barthel activities of daily living test
- Ability to walk independently (with or without walking aids)
Key exclusion criteria (5 listed)
- Having a defined neurological (including vertigo), orthopedic, orthopedic, psychiatric, systemic (cardiovascular, cachectic due to malnutrition) disease that prevents walking and mobility
- Being in the statin drug group
- Diagnosis of sarcopenia
- Having communication problems
- Visual impairment (severe) or hearing impairment (severe)
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 |
|---|---|---|
| EXERCISE TRAININGPHYSIOTHERAPY PROGRAM | Other | Group 2-EXERCISE |
| NMESPHYSIOTHERAPY PROGRAM | Other | Group 1-NMES |
Primary outcome
Ultrasound Imaging
Time frame: baseline and week 13
Thickness measurements for both lower extremity quadriceps femoris muscle and tibialis anterior muscle will be evaluated. For resting muscle thickness, the person will be positioned in a supine position with the knee extended and the leg in neutral rotation (weights will be placed on the ankles to prevent external rotation laterally). The distance between the spina iliaca anterior superior and the upper border of the patella on the anterior thigh region will be measured with a tape measure, the probe will be placed transversely on the long axis of the thigh so that it is 1/3 of the distance close to the patella, and this area will be marked with a pencil. When evaluating the tibialis anterior muscle, the patient will be in the supine position at a point corresponding to 30% of the distance between the lateral tibial condyle and the lateral malleolus. Transmission gel will be used between the skin and the ultrasound head.
Assessment of Muscle Strength
Time frame: bbaseline and week 13
Quadriceps and tibialis anterior muscle strength will be measured with digital handheld dynamometer. The digital muscle measurement device is a portable device with 3 interchangeable heads and a digital LCD screen. The device can provide data such as Peak power, time to reach peak power, total test time and average force in kg Newton and pounds. For the measurement of Quadriceps strength on both legs; the test will begin with the participants sitting on a flat surface with their hips and knees flexed at 90 degrees. The dynamometer will be placed perpendicular to the leg, 1-2 cm above the level of the malleoli. The "make test" technique, which requires isometric contraction, will be applied. All measurements will be taken twice from both legs of the participants by the same researcher with the same hand. For the Tibialis anterior strength measurement on both legs, the participant will be asked to dorsiflex their ankles while lying face down on a flat table.
6 secondary outcomes
10-Meter Walking Test
Time frame: baseline and week 13
Dynamic Balance Test (Timed Up and Go Test)
Time frame: baseline and week 13
Static Balance Test (One-Legged Standing Test)
Time frame: baseline and week 13
Sit-to-Stand Chair Test
Time frame: baseline and week 13
Assessment of Fall Risk
Time frame: baseline and week 13
Participant Satisfaction Assessment
Time frame: baseline and week 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 24030238Cadore EL, Casas-Herrero A, Zambom-Ferraresi F, Idoate F, Millor N, Gomez M, Rodriguez-Manas L, Izquierdo M. Multicomponent exercises including muscle power training enhance muscle mass, power output, and functional outcomes in institutionalized frail nonagenarians. Age (Dordr). 2014 Apr;36(2):773-85. doi: 10.1007/s11357-013-9586-z. Epub 2013 Sep 13.
- Background: PubMed 32911822Sarabon N, Kozinc Z, Lofler S, Hofer C. Resistance Exercise, Electrical Muscle Stimulation, and Whole-Body Vibration in Older Adults: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Sep 8;9(9):2902. doi: 10.3390/jcm9092902.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
UGUR CAVLAK, Prof. principal investigator
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING and NMES in people with Neuromuscular Electrical Stimulation, run by Biruni University at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ultrasound Imaging (time frame: baseline and week 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07076797, which also lists 2 linked publications.
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 9 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.