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

Not Applicable

Completed

• Conditions: Frail Elderly Syndrome
• Interventions: Other: WBV + IMTsham; Other: WBVsham + IMTsham; Other: WBV + IMT

• Registration Number: NCT03689322
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Study Start: 2018-10-01
• Primary Completion: 2019-05-30
• Study Completion: 2019-07-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WBV + IMTsham	WBV + IMTsham	Whole body vibration training associated with respiratory muscle training sham (WBV + IMTsham)
WBVsham + IMTsham	WBVsham + IMTsham	Whole body vibration training sham associated with respiratory muscle training sham (WBVsham + IMTsham)
WBV + IMT	WBV + IMT	Whole body vibration training associated with respiratory muscle training (WBV + IMT)

Primary Outcome Measures

Name	Time	Method
Respiratory Muscle Strength and Resistance	Change from Baseline respiratory muscle strength and resistance at 3 months	Maximum Inspiratory and Expiratory Pressure will be evaluated through manovacuometer

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	Change from Baseline inflammatory markers at 3 months	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.
Diaphragmatic thickness	Change from Baseline diaphragmatic thickness at 3 months	Ultrasound will to use to evaluate diaphragm thickness non-invasively in the zone of apposition during tidal breathing and with changes in lung volume.
Body Composition	Change from Baseline body composition at 3 months	Body composition will be evaluated through bioimpedance balance
Thickness of the quadriceps muscle	Change from Baseline thickness of the quadriceps muscle at 3 months	Ultrasound will be used to assess the thickness of the quadriceps muscle according to the pre-established protocol.
Diaphragmatic mobility	Change from Baseline diaphragmatic mobility at 3 months	During respiration to total lung capacity, measurement of the diaphragmatic excursion will be assessed by ultrasonography.

Trial Locations

Locations (1)

Federal University of Pernambuco; 🇧🇷 Recife, Pernambuco, Brazil