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

NCT07076797 | Recruiting

• 1 other identifier: BiruniUniversityIst
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  bbaseline and week 13

Secondary Outcomes (6)

• 10-Meter Walking Test

  baseline and week 13

• Dynamic Balance Test (Timed Up and Go Test)

  baseline and week 13

• Static Balance Test (One-Legged Standing Test)

  baseline and week 13

• Sit-to-Stand Chair Test

  baseline and week 13

• Assessment of Fall Risk

  baseline and week 13

Study Arms (2)

Group 1-NMES

EXPERIMENTAL

experimental group will receive neuromuscular electrical stimulation

Other: NMES

Group 2-EXERCISE

ACTIVE COMPARATOR

acticve comparator group will receive exercise training

Other: EXERCISE TRAINING

Interventions

EXERCISE TRAINING OTHER

PHYSIOTHERAPY PROGRAM

Group 2-EXERCISE

NMES OTHER

PHYSIOTHERAPY PROGRAM

Group 1-NMES

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Faculty of Health Sciences in Biruni University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 24030238 BACKGROUND

• Sarabon 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.

  PMID: 32911822 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• UGUR CAVLAK, Prof.

  Biruni University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

UGUR CAVLAK

CONTACT

05324519644; ucavlak@biruni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not know the group distrubution.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROF. PhD

Model Details: a randomized controlled study.

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 22, 2025
• Study Start: October 15, 2025
• Primary Completion: January 10, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)