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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03689322
Other study ID # WBV on inflammatory biomarkers
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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