Effects of Whole Body Vibration in Pre-frail Individuals Over 65 Years of Age: Randomized Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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 progresion 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.

Official Title
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The Relationship Between Whole Body Vibration and Muscle Strength and Thickness, Body Composition, Physical Performance, Balance, Kinesiophobia, Mood, Fatigue, Quality of Life, and Sleep in Pre-frail Individuals Over 65 Years of Age: Randomized Clinical Trial

Conditions
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Pre-frail

Intervention / Treatment
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* Other: Whole body vibration
* Other: The exercise program on flat ground without a vibration platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) Pregnancy Epilepsy 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibration group<br>An exercise program organized by the researchers on the vibration platform will be applied to the pre-frail participants in the vibration group. The exercises will be applied 5 days a week for 6 weeks. | Other: Whole body vibration<br>* All patients will be pedaling for 5 minutes, followed by a warm-up phase with 5 minutes of stretching for the hamstring, gastrocnemius, soleus, and quadriceps muscles. Afterward, the following exercise program on the vibration platform will be applied to the 1st group. Lunge, Squat, Deep squat, Wide stance squat, Calves, Deep calves. The exercise time will be 6 minutes in the first week, and the exercise time will be increased in the following weeks, and the total exercise time will continue at 18 minutes in the last week.<br>|
| Active Comparator: Control group<br>An exercise program organized by the researchers (same exercise program as the vibration group) will be applied to the pre-frail participants in the control group on a flat surface. The exercises will be applied 5 days a week for 6 weeks. | Other: The exercise program on flat ground without a vibration platform<br>* All patients will be pedaling for 5 minutes, followed by a warm-up phase with 5 minutes of stretching for the hamstring, gastrocnemius, soleus, and quadriceps muscles. Afterward, the following exercise program will be applied to the group. The exercise program will be applied to the 2nd group (controls) on flat ground without a vibration platform. Lunge, Squat, Deep squat, Wide stance squat, Calves, Deep calves. The exercise time will be 6 minutes in the first week, and the exercise time will be increased in the following weeks, and the total exercise time will continue at 18 minutes in the last week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior thigh muscle thickness | Anterior thigh muscle thickness will be measured in centimeters by ultrasonography. | Change from baseline anterior thigh muscle thickness at second, fourth and sixth weeks of intervention. | 
| Lower Extremity Muscle Strength | 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. | Change from baseline lower extremity muscle strength at sixth weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand grip strength | Hand grip strength is a reliable measurement when standardised methods and calibrated equipment are used, even when there are different assessors or different brands of dynamometers. Hand grip strength will be measured by Jamar Analogue Hand Dynamometer in kilograms. | Change from baseline hand grip strength at sixth weeks of intervention | 
| Skeletal muscle mass index (SMI) | Skeletal muscle mass index (SMI) will be measured in kg/m² by dividing the appendicular skeletal muscle mass (kg) by the square of the height (m) using bioelectrical impedance analysis (BIA). | Change from baseline skeletal muscle mass index at sixth weeks of intervention | 
| Physical performance | The Short Physical Performance Battery (SPPB) is used to determine physical performance. The SPPB is a composite test that includes assessment of walking speed, balance test, and chair rise test. | Change from baseline physical performance at sixth weeks of intervention | 
| Mobility | Mobility will be determined by the timed get-and-go test. The test measures speed during many functional maneuvers such as standing up, walking, turning, and sitting. | Change from baseline mobility at sixth weeks of intervention | 
| Physical activity | Physical activity will be assessed using the International Physical Activity Questionnaire - short form (IPAQ). It provides information about time spent walking, moderate- intensity activity, vigorous-intensity activity and sedentary activity. | Change from baseline physical activity at sixth weeks of intervention | 
| Balance | Balance will be scored by Berg balance test and Tinetti balance-gait tests. Berg balance test scores balance between 0 to 56 in which higher score means better outcome. Tinetti balance-gait test scores balance between 0 to 9 in which higher score means better outcome. | Change from baseline balance at sixth weeks of intervention | 
| Kinesiophobia | Kinesiophobia will be determined by the Tampa Kinesiophobia Scale. It consists of 17 questions including pain, injury, fear and avoidance parameters related to physical activities. | Change from baseline kinesiophobia at sixth weeks of intervention | 
| Mood | Depression will be assessed using Geriatric Depression Scale. This scale consists of 30 questions. A total score of 0-10 means no depression, 11-13 means likely depression, above 14 means definite depression. | Change from baseline mood at sixth weeks of intervention | 
| Life quality | The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, self-reported measure of health. Life quality will be mesaured by SF-36. In this test every subgroup is scored between 0 to 100 and higher score means better outcome. | Change from baseline life quality at sixth weeks of intervention | 
| Sleep quality | Sleep quality will be determined by The Pittsburgh Sleep Quality Index (PSQI). The scale includes 7 components. Every component is scored between 0 to 3. A total score above 5 is considered poor sleep quality. | Change from baseline sleep quality at sixth weeks of intervention | 
| Fatigue | Fatigue will be evaluated with the fatigue severity scale. The scale includes 9 questions, each of which consists of a score scale of 1-7. The scale determines the fatigue levels of the participants in the last 1 month. | Change from baseline fatigue at sixth weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whole body vibration, Pre-frail, Anterior thigh muscle thickness, Fraility