Differential Effects of Whole-Body Vibration and Floor Exercises on Muscle Architecture, Functional Performance, and Well-Being in Pre-Frail Seniors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Anterior thigh muscle thickness
研究概览
简要总结
In this study, individuals aged 65 and over who applied to the physical medicine and rehabilitation outpatient clinic with any complaint will be evaluated in terms of geriatric syndromes. Patients identified as pre-frail will be randomized into the two exercise groups. Exercises of the first group will be performed on the whole body vibration platform and the second will be performed on a flat surface. Before and after the 6-weeks of exercise program; handgrip strength, anterior thigh muscle thickness, body composition, physical performance, mobility, physical activity, balance, kinesiophobia, mood, quality of life, sleep quality, fatigue will be evaluated in both groups. The aim of the study is to show the possible effects of whole body vibration. The results of the study may offer new treatment options that may help prevent the progression of frailty in pre-frail individuals and may guide similar studies.
详细描述
Frailty is included in geriatric syndromes and is accepted as a precursor of other geriatric syndromes. The elderly who do not meet all the frailty criteria but are at risk are defined as "pre-frail". In many studies %50 of individuals aged 65 and over who appear healthy have been identified at an early stage and their progression to frailty can be reduced or prevented.
Proven treatment approaches for physical frailty include aerobic and resistive exercise. As a result of this study, it is predicted that whole body vibration may be an alternative treatment modality for "pre-frail " individuals who cannot do aerobic and resistive exercises or who are inconvenient to do these exercises.
In the literature, the effect of whole body vibration on muscle strength, balance, physical performance and spasticity in various age groups have been shown. There are no studies showing the effect of whole body vibration in pre-frail individuals and investigating the effect of whole body vibration on anterior thigh muscle thickness. In this study, pre-frail patients will be randomized into exercise groups. 6-week exercise programme is planned to be performed on whole body vibration platform for one group and on flat ground for the other group. The relationship between whole body vibration application and anterior thigh muscle thickness will be examined by measuring the anterior thigh muscle thickness of all participants via ultrasonography (USG). In addition, the relationship between whole body vibration application and body composition, physical performance, balance, kinesiophobia, mood, fatigue, quality of life and sleep will be examined.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years and older
- •Those who agreed to participate in the study
- •Groups that have the authority to understand and listen to the questions posed
- •Having no regular exercise habits
排除标准
- •Communication disorder that prevents storytelling and cooperation
- •Serious neurological disease (central nervous system disorders such as paralysis, spinal cord injury, parkinsonism)
- •Advanced cardiovascular disease (decongestive heart failure, recent myocardial infarction)
- •Serious pulmonary disease (COPD exacerbation, acute pulmonary embolism)
- •Physical disability such as lower extremity amputation, surgery
- •Implant (pacemaker, artificial heart valve, stent, hip replacement, knee replacement)
- •Having gallstones, kidney stones, bladder stones
- •Acute inflammation, infection
- •Acute or previous deep vein thrombosis
- •Presence of a history of malignant disease
- •History of fracture in the last 6 months
- •History of lower extremity surgery in the last 12 months
- •Having a regular exercise habit
结局指标
主要结局
Anterior thigh muscle thickness
时间窗: Change from baseline anterior thigh muscle thickness at second, fourth and sixth weeks of intervention.
Anterior thigh muscle thickness will be measured in centimeters by ultrasonography.
Lower Extremity Muscle Strength
时间窗: Change from baseline lower extremity muscle strength at sixth weeks of intervention
The lower extremities will be evaluated by chair rise test ( also called chair stand test). This test can be used as a proxy for strength of leg muscles (quadriceps muscle group). The chair stand test measures the amount of time needed for a patient to rise five times from a seated position without using his or her arms; the timed chair stand test is a variation that counts how many times a patient can rise and sit in the chair over a 30-second interval.
次要结局
- Hand grip strength(Change from baseline hand grip strength at sixth weeks of intervention)
- Skeletal muscle mass index (SMI)(Change from baseline skeletal muscle mass index at sixth weeks of intervention)
- Physical performance(Change from baseline physical performance at sixth weeks of intervention)
- Mobility(Change from baseline mobility at sixth weeks of intervention)
- Physical activity(Change from baseline physical activity at sixth weeks of intervention)
- Balance(Change from baseline balance at sixth weeks of intervention)
- Kinesiophobia(Change from baseline kinesiophobia at sixth weeks of intervention)
- Mood(Change from baseline mood at sixth weeks of intervention)
- Life quality(Change from baseline life quality at sixth weeks of intervention)
- Sleep quality(Change from baseline sleep quality at sixth weeks of intervention)
- Fatigue(Change from baseline fatigue at sixth weeks of intervention)