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

Frail Elderly Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689322
• Other study ID #: WBV on inflammatory biomarkers
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: September 2019
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly Syndrome

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Body Composition	Body composition will be evaluated through bioimpedance balance	Change from Baseline body composition at 3 months
Secondary	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