Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689322
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Helga Cecília Muniz de Souza, 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.

Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Other: WBV + IMT Other: WBV + IMTsham Other: WBVsham + IMTsham Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Whole Body Vibration Associated With the Inspiratory Muscle Training Program on Inflammatory Markers, Body Composition, Muscle Strength and Thickness
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : July 30, 2019

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689322


Locations
Layout table for location information
Brazil
Federal University of Pernambuco
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Universidade Federal de Pernambuco
Layout table for additonal information
Responsible Party: Helga Cecília Muniz de Souza, Principal Investigator, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03689322    
Other Study ID Numbers: WBV on inflammatory biomarkers
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco:
aging
whole body vibration
respiratory muscle training