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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03688932
Other study ID # WBV on Functionality
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

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.


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:

- 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 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 Walking Distance The walking distance will be assessed through the six-minute walk test. Change from Baseline walking distance at 3 months
Secondary Balance Static balance and dynamic balance will be evaluated through the Tinetti test Change from Baseline balance at 3 months
Secondary Functionality It will be evaluated through the Timed Up and Go (TUG) test. Change from Baseline functionality at 3 months
Secondary Hand grip strength The strength of the dominant hand will be evaluated by dynamometry. Change from Baseline hand grip strength at 3 months
Secondary Muscle Metabolism It will be assessed through the blood lactate and glucose rate after moderate physical activity. Change from Baseline muscle metabolism at 3 months
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