Effects of WBV Associated With IMT on Inflammatory Markers, Body Composition, Muscle Strength and Thickness

Study Overview
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Brief Summary
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Aging generates immune, muscular and functional changes. In the pre-frail elderly these changes may be increased and, therefore, preventive interventions are indicated to minimize the consequences of sarcopenia in this population. This study aims to evaluate the effects of a whole body vibration training associated with the training of inspiratory muscles on the inflammatory, muscular and body composition outcomes in pre-frail elderly women.

Official Title
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Effects of Whole Body Vibration Associated With the Inspiratory Muscle Training Program on Inflammatory Markers, Body Composition, Muscle Strength and Thickness

Conditions
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Frail Elderly Syndrome

Intervention / Treatment
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* Other: WBV + IMT
* Other: WBV + IMTsham
* Other: WBVsham + IMTsham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly individuals able to walk without assistance Good understanding to carry out the proposed tests, evaluated through the Mini Mental State Examination (MMSE). Exclusion Criteria: Contraindication or difficulty to perform evaluation procedures Users of medications that interfere with the cardiovascular and / or muscular system Smokers Neuromuscular or degenerative diseases Pulmonary comorbidities Heart diseases Labyrinthitis.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WBV + IMT<br>Whole body vibration training associated with respiratory muscle training (WBV + IMT) | Other: WBV + IMT<br>* The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training will be performed through a device that provides inspiratory resistance.<br>|
| Active Comparator: WBV + IMTsham<br>Whole body vibration training associated with respiratory muscle training sham (WBV + IMTsham) | Other: WBV + IMTsham<br>* The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training sham will be performed through a device without inspiratory resistance.<br>|
| Sham Comparator: WBVsham + IMTsham<br>Whole body vibration training sham associated with respiratory muscle training sham (WBVsham + IMTsham) | Other: WBVsham + IMTsham<br>* Whole body vibration training will be performed through a vibrating platform coupled to a device that generates non-therapeutic low frequency vibration. The simulation of inspiratory muscle training will be performed through a device with no inspiratory resistance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Muscle Strength and Resistance | Maximum Inspiratory and Expiratory Pressure will be evaluated through manovacuometer | Change from Baseline respiratory muscle strength and resistance at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of the quadriceps muscle | Ultrasound will be used to assess the thickness of the quadriceps muscle according to the pre-established protocol. | Change from Baseline thickness of the quadriceps muscle at 3 months | 
| Diaphragmatic thickness | Ultrasound will to use to evaluate diaphragm thickness non-invasively in the zone of apposition during tidal breathing and with changes in lung volume. | Change from Baseline diaphragmatic thickness at 3 months | 
| Diaphragmatic mobility | During respiration to total lung capacity, measurement of the diaphragmatic excursion will be assessed by ultrasonography. | Change from Baseline diaphragmatic mobility at 3 months | 
| Body Composition | Body composition will be evaluated through bioimpedance balance | Change from Baseline body composition at 3 months | 
| Inflammatory markers | Blood concentration of Interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha) and brain-derived neurotrophic factor (BDNF) will be assessed through blood plasma sample. | Change from Baseline inflammatory markers at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aging, whole body vibration, respiratory muscle training