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Effects of WBV Associated With IMT on Functionality

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: NCT03688932
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

Study Description
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Brief Summary:
The pre-frail elderly are a population more vulnerable to diminished functionality and future disabilities. Thus, interventions focused on the prevention of sarcopenia are indicated to prevent dysfunction in this population. This study aims to evaluate the effects of whole body vibration training associated with inspiratory muscle training on functional outcomes, balance and muscle metabolism 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

Study Design
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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 Functional Capacity, Balance and Muscle Metabolism
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : July 30, 2019
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Walking Distance [ Time Frame: Change from Baseline walking distance at 3 months ]
    The walking distance will be assessed through the six-minute walk test.


Secondary Outcome Measures :
  1. Balance [ Time Frame: Change from Baseline balance at 3 months ]
    Static balance and dynamic balance will be evaluated through the Tinetti test

  2. Functionality [ Time Frame: Change from Baseline functionality at 3 months ]
    It will be evaluated through the Timed Up and Go (TUG) test.

  3. Hand grip strength [ Time Frame: Change from Baseline hand grip strength at 3 months ]
    The strength of the dominant hand will be evaluated by dynamometry.

  4. Muscle Metabolism [ Time Frame: Change from Baseline muscle metabolism at 3 months ]
    It will be assessed through the blood lactate and glucose rate after moderate physical activity.


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

Inclusion Criteria:

  • To 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 and labyrinthitis
Contacts and Locations
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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): NCT03688932


Locations
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Brazil
Federal University of Pernambuco
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Universidade Federal de Pernambuco
More Information
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Responsible Party: Helga Cecília Muniz de Souza, Msc, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03688932    
Other Study ID Numbers: WBV on Functionality
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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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
functional capacity
muscle metabolism