Efficacy of Vestibular Physiotherapy Against Multi-component Exercise in Functional Improvement in the Elderly

June 11, 2023 updated by: MARINA LOPEZ GARCIA, University of Seville

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41012
        • Fundomar Elderly nursing home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VESTIBULAR EXERCISE at home telerehabilitation

1. The vestibular exercises were performed with the indications of a physical therapist, in sessions of about 20 minutes with 5 times per week (Monday to Friday) consisting of 5 repetitions ensuring the following were not overworked:

  1. Head and eye movements while sitting.
  2. Head and body movements while sitting.
  3. Paused exercises.
  4. Combined exercises of modifications on rungs, unstable surfaces and walking exercises.
Procedure: Experimental: VESTIBULAR EXERCISE
OCULAR AND MOVEMENT EXERCISES
Experimental: MULTICOMPONENT EXERCISE at home telerehabilitaion
1. A 6-week multi-component therapeutic physical exercise program was carried out. The ministerial guide and the "Vivifrail" consensus was followed (25, 26). There were 5 daily sessions per week (Monday to Friday), each lasting approximately 45 minutes. These sessions were conducted following the instructions of a physical therapist. VIVIFRAIL exercises are intended to be used over a progression period of up to 12 weeks, with combined exercises by days in cardiovascular aerobic balance strength and flexibility.
Procedure: MULTICOMPONENT EXERCISE
exercises includes strengthening, cardiovascular training, flexibility and balance
Experimental: VESTIBULAR EXERCISE in clinic

1. The vestibular exercises were performed with the indications of a physical therapist, in sessions of about 20 minutes with 5 times per week (Monday to Friday) consisting of 5 repetitions ensuring the following were not overworked:

  1. Head and eye movements while sitting.
  2. Head and body movements while sitting.
  3. Paused exercises.
  4. Combined exercises of modifications on rungs, unstable surfaces and walking exercises.
Procedure: Experimental: VESTIBULAR EXERCISE
OCULAR AND MOVEMENT EXERCISES
Experimental: multi component exercise in clinic
1. A 6-week multi-component therapeutic physical exercise program was carried out. The ministerial guide and the "Vivifrail" consensus was followed (25, 26). There were 5 daily sessions per week (Monday to Friday), each lasting approximately 45 minutes. These sessions were conducted following the instructions of a physical therapist. VIVIFRAIL exercises are intended to be used over a progression period of up to 12 weeks, with combined exercises by days in cardiovascular aerobic balance strength and flexibility.
Procedure: MULTICOMPONENT EXERCISE
exercises includes strengthening, cardiovascular training, flexibility and balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline at 6 weeks
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).
Change from Baseline at 6 weeks
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.
Change from Baseline at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Investigators

  • Principal Investigator: MARINA LOPEZ LOPEZ-GARCIA, PT, University of Seville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2021

Primary Completion (Actual)

September 12, 2021

Study Completion (Actual)

October 4, 2021

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 31, 2020

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2410-N-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are not to share de individual participants data to another investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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