Effects of WBV Associated With IMT on Functionality

NCT03688932 | Completed

• 1 other identifier: WBV on Functionality
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly Syndrome

Keywords

aging; functional capacity; muscle metabolism

Outcome Measures

Primary Outcomes (1)

• Walking Distance

  The walking distance will be assessed through the six-minute walk test.

  Change from Baseline walking distance at 3 months

Secondary Outcomes (4)

• Balance

  Change from Baseline balance at 3 months

• Functionality

  Change from Baseline functionality at 3 months

• Hand grip strength

  Change from Baseline hand grip strength at 3 months

• Muscle Metabolism

  Change from Baseline muscle metabolism at 3 months

Study Arms (3)

WBV + IMT

EXPERIMENTAL

Whole body vibration training associated with respiratory muscle training (WBV + IMT)

Other: WBV + IMT

WBV + IMTsham

ACTIVE COMPARATOR

Whole body vibration training associated with respiratory muscle training sham (WBV + IMTsham)

Other: WBV + IMTsham

WBVsham + IMTsham

SHAM COMPARATOR

Whole body vibration training sham associated with respiratory muscle training sham (WBVsham + IMTsham)

Other: WBVsham + IMTsham

Interventions

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 + IMT

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.

WBV + IMTsham

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.

WBVsham + IMTsham

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To able to walk without assistance
• Good understanding to carry out the proposed tests, evaluated through the Mini Mental State Examination (MMSE).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 28, 2018
• Study Start: October 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: July 30, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

BR (1)