Effects of WBV Associated With IMT on Functionality

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: Frail Elderly Syndrome
• Intervention / Treatment: Other: WBV + IMT; Other: WBV + IMTsham; Other: WBVsham + IMTsham

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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	Static balance and dynamic balance will be evaluated through the Tinetti test	Change from Baseline balance at 3 months
Functionality	It will be evaluated through the Timed Up and Go (TUG) test.	Change from Baseline functionality at 3 months
Hand grip strength	The strength of the dominant hand will be evaluated by dynamometry.	Change from Baseline hand grip strength at 3 months
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

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

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: aging; functional capacity; muscle metabolism
• 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