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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-NMES | Experimental | experimental group will receive neuromuscular electrical stimulation |
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| Group 2-EXERCISE | Active Comparator | acticve comparator group will receive exercise training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXERCISE TRAINING | Other | PHYSIOTHERAPY PROGRAM |
| |
| NMES |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline and week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UGUR CAVLAK | Contact | 05324519644 | ucavlak@biruni.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| UGUR CAVLAK, Prof. | Biruni University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health Sciences in Biruni University | Recruiting | Istanbul | Zeytinburnu | 34010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24030238 | Background | 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. | |
| 32911822 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study protocol | Dec 10, 2024 | Dec 5, 2025 | Prot_SAP_ICF_000.pdf |
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: PROTOCOL and ICF | Dec 10, 2024 | Dec 5, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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a randomized controlled study.
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The participants will not know the group distrubution.
| Other |
PHYSIOTHERAPY PROGRAM |
|
| 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). | 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. | 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. | 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. | 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. | baseline and week 13 |
| 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. |