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NCT Number: NCT07076797

Effects of Lower Extremity Functional Exercise Program and Neuromuscular Electrical Nerve Stimulation in Older Adults

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.

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Key information

Age range

65 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences in Biruni University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location status: Recruiting

Location contact

UGUR CAVLAK, Prof., PhD.

CONTACT

[email protected]

00905324519644

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Exercise training

Other

PHYSIOTHERAPY PROGRAM

NMES

Other

PHYSIOTHERAPY PROGRAM

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 10-Meter Walking Test

    Time frame: baseline and week 13

    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)

  2. Dynamic Balance Test (Timed Up and Go Test)

    Time frame: baseline and week 13

    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).

  3. Static Balance Test (One-Legged Standing Test)

    Time frame: baseline and week 13

    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.

  4. Sit-to-Stand Chair Test

    Time frame: baseline and week 13

    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.

  5. Assessment of Fall Risk

    Time frame: baseline and week 13

    The Fullerton Balance Scale (FAB-T) will be used. It was developed to identify more subtle changes in multiple dimensions of balance.

  6. Participant Satisfaction Assessment

    Time frame: baseline and week 13

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

UGUR CAVLAK

CONTACT

[email protected]

05324519644

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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