Effects of WBV Associated With IMT on Functionality

September 24, 2019 updated by: Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco

Effects of Whole Body Vibration Associated With the Inspiratory Muscle Training Program on Functional Capacity, Balance and Muscle Metabolism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Federal University of Pernambuco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Distance
Time Frame: Change from Baseline walking distance at 3 months
The walking distance will be assessed through the six-minute walk test.
Change from Baseline walking distance at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: Change from Baseline balance at 3 months
Static balance and dynamic balance will be evaluated through the Tinetti test
Change from Baseline balance at 3 months
Functionality
Time Frame: Change from Baseline functionality at 3 months
It will be evaluated through the Timed Up and Go (TUG) test.
Change from Baseline functionality at 3 months
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.
Change from Baseline hand grip strength at 3 months
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.
Change from Baseline muscle metabolism at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ACTUAL)

May 30, 2019

Study Completion (ACTUAL)

July 30, 2019

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (ACTUAL)

September 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WBV on Functionality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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