Effects of Whole Body Vibration in Pre-frail Individuals Over 65 Years of Age

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-03-01

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.

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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 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.

Conditions

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Pre-frail

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vibration group

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.

Group Type EXPERIMENTAL

Whole body vibration

Intervention Type OTHER

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.

Control group

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.

Group Type ACTIVE_COMPARATOR

The exercise program on flat ground without a vibration platform

Intervention Type OTHER

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.

Interventions

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Whole body vibration

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.

Intervention Type OTHER

The exercise program on flat ground without a vibration platform

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 65 years and older
2. Those who agreed to participate in the study
3. Groups that have the authority to understand and listen to the questions posed
4. Having no regular exercise habits

Exclusion Criteria

1. Communication disorder that prevents storytelling and cooperation
2. Serious neurological disease (central nervous system disorders such as paralysis, spinal cord injury, parkinsonism)
3. Advanced cardiovascular disease (decongestive heart failure, recent myocardial infarction)
4. Serious pulmonary disease (COPD exacerbation, acute pulmonary embolism)
5. Physical disability such as lower extremity amputation, surgery
6. Implant (pacemaker, artificial heart valve, stent, hip replacement, knee replacement)
7. Pregnancy
8. Epilepsy
9. Having gallstones, kidney stones, bladder stones
10. Acute inflammation, infection
11. Acute or previous deep vein thrombosis
12. Presence of a history of malignant disease
13. History of fracture in the last 6 months
14. History of lower extremity surgery in the last 12 months
15. Having a regular exercise habit

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No