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Clinical Trials/NCT04690777
NCT04690777
Completed
N/A

Efficacy of Vestibular Physiotherapy Against Multi-component Exercise in Functional Improvement in the Elderly": Pilot Study of a Randomized Clinical Trial

University of Seville1 site in 1 country40 target enrollmentJuly 4, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Physical Therapy
Sponsor
University of Seville
Enrollment
40
Locations
1
Primary Endpoint
Movement Capacity: SPPB (Short Physical Performance Battery) Physical Function Valuation Battery
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Loss of vestibular function occurs normally with healthy aging but can produce symptoms that reduce motor skills and cause falls. vestibular physical therapy (VPH) exercises are a specific approach to reducing imbalances. The multicomponent therapeutic physical exercise (ME) is an effective non-pharmacological strategy for the improvement of physical condition.

Objective: to determine the efficacy of ME versus VPH for gait improvement. Material and method: a randomized clinical trial was carried out with two intervention groups , applying it to one VPH group and the other ME.

The participants were residents of Geriatric Centers in the province of Seville, Spain with a score between 4 and 9 points according to the "Short Physical Performance Battery" scale (SPPB).

Detailed Description

This pilot study is a controlled and randomized clinical trial (simple ER) with two groups in parallel, comparing the combination of a multi-component therapeutic exercise protocol (ME) versus vestibular exercises (VPH) in over 70 years. The trial was approved by the Ethics Committee on Research with code 2410-N-19 and the study was conducted in accordance with the Helsinki Declaration.

Registry
clinicaltrials.gov
Start Date
July 4, 2021
End Date
October 4, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

MARINA LOPEZ GARCIA

Associate Professor

University of Seville

Eligibility Criteria

Inclusion Criteria

  • Males and females over 70 years of age.
  • Subjects with a score between 4 and 9 points on the. "Short Physical Performance Battery"" (SPPB) scale

Exclusion Criteria

  • Patients unable to walk unaided or those who do not exceed the previous evaluation in SPPB.
  • Polypharmacological patients (combined use of beta blockers, sulpiride or betahistin) were also excluded.

Outcomes

Primary Outcomes

Movement Capacity: SPPB (Short Physical Performance Battery) Physical Function Valuation Battery

Time Frame: Change from Baseline at 6 weeks

The SPPB fitness rating battery consists of three parts: Balance rating, 4 metre gait assessment rating and the Time up and go test (TUG). From 0 (bad) to 12 (well) there is a score which describes de functionality

Test Time up and Go

Time Frame: Change from Baseline at 6 weeks

The participants try to stand up and wlak 3 metres and return sitting. We must record the time. 1) This is a continuous quantitative variable measured in seconds.

Speed test

Time Frame: Change from Baseline at 6 weeks

Speed test. A participants walking speed over a 4 metre distance. This is a continuous quantitative variable measured in meters per second (m/s).

Study Sites (1)

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