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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Ultrasound Imaging
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participants will not know the group distrubution.
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Group 1-NMES
experimental group will receive neuromuscular electrical stimulation
干预措施: NMES (Other)
Group 2-EXERCISE
acticve comparator group will receive exercise training
干预措施: EXERCISE TRAINING (Other)
结局指标
主要结局
Ultrasound Imaging
时间窗: 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
时间窗: 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.
Ultrasound Imaging
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Participant Satisfaction Assessment(baseline and week 13)
- 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)
- Participant Satisfaction Assessment(baseline and week 13)
研究者
Ugur Cavlak
PROF. PhD
Biruni University