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OpenTrials
Completed

NCT Number: NCT03689322

Effects of WBV Associated With IMT 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.

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Key information

Conditions

Frail Elderly Syndrome

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Pernambuco

Recife, Pernambuco, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WBV + IMT

Other

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

Other

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

Other

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.

Primary outcomes

  1. Respiratory Muscle Strength and Resistance

    Time frame: Change from Baseline respiratory muscle strength and resistance at 3 months

    Maximum Inspiratory and Expiratory Pressure will be evaluated through manovacuometer

Secondary outcomes

  1. Thickness of the quadriceps muscle

    Time frame: 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.

  2. Diaphragmatic thickness

    Time frame: 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.

  3. Diaphragmatic mobility

    Time frame: Change from Baseline diaphragmatic mobility at 3 months

    During respiration to total lung capacity, measurement of the diaphragmatic excursion will be assessed by ultrasonography.

  4. Body Composition

    Time frame: Change from Baseline body composition at 3 months

    Body composition will be evaluated through bioimpedance balance

  5. Inflammatory markers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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