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

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

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.

Study Overview

• Status: Completed
• Conditions: Frail Elderly Syndrome
• Intervention / Treatment: Other: WBV + IMT; Other: WBV + IMTsham; Other: WBVsham + IMTsham

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil
      • Federal University of Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WBV + IMT; Whole body vibration training associated with respiratory muscle training (WBV + IMT)	Other: WBV + IMT; 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.
Active Comparator: WBV + IMTsham; Whole body vibration training associated with respiratory muscle training sham (WBV + IMTsham)	Other: WBV + IMTsham; 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.
Sham Comparator: WBVsham + IMTsham; Whole body vibration training sham associated with respiratory muscle training sham (WBVsham + IMTsham)	Other: WBVsham + IMTsham; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: aging; whole body vibration; respiratory muscle training
• Other Study ID Numbers: WBV on inflammatory biomarkers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No