NCT03689322

Brief Summary

Aging generates immune, muscular and functional changes. In the pre-frail elderly these changes may be increased and, therefore, preventive interventions are indicated to minimize the consequences of sarcopenia in this population. This study aims to evaluate the effects of a whole body vibration training associated with the training of inspiratory muscles on the inflammatory, muscular and body composition outcomes in pre-frail elderly women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

September 25, 2018

Last Update Submit

September 24, 2019

Conditions

Frail Elderly Syndrome

Keywords

agingwhole body vibrationrespiratory muscle training

Outcome Measures

Primary Outcomes (1)

  • Respiratory Muscle Strength and Resistance

    Maximum Inspiratory and Expiratory Pressure will be evaluated through manovacuometer

    Change from Baseline respiratory muscle strength and resistance at 3 months

Secondary Outcomes (5)

  • Thickness of the quadriceps muscle

    Change from Baseline thickness of the quadriceps muscle at 3 months

  • Diaphragmatic thickness

    Change from Baseline diaphragmatic thickness at 3 months

  • Diaphragmatic mobility

    Change from Baseline diaphragmatic mobility at 3 months

  • Body Composition

    Change from Baseline body composition at 3 months

  • Inflammatory markers

    Change from Baseline inflammatory markers 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 + IMTOTHER

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 + IMTshamOTHER

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 + IMTshamOTHER

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

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly individuals 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
  • Labyrinthitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Principal Investigator

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)