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

Sponsor

University of Seville (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04690777

Collaborator

(none)

Enrollment

Arms

1.7

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Physical Therapy Sports Physical Therapy Exercise Therapy Gait	Procedure: Experimental: VESTIBULAR EXERCISE Procedure: MULTICOMPONENT EXERCISE	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model 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 (MS) versus vestibular exercises (EVs) in over 70 years. participants were randomly assigned to the therapeutic exercise group or the vestibular exercise groupThis 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 (MS) versus vestibular exercises (EVs) in over 70 years. participants were randomly assigned to the therapeutic exercise group or the vestibular exercise group

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 4, 2021

Anticipated Primary Completion Date :

Jan 12, 2021

Anticipated Study Completion Date :

Feb 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VESTIBULAR EXERCISE 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: Head and eye movements while sitting. Head and body movements while sitting. Paused exercises. Combined exercises of modifications on rungs, unstable surfaces and walking exercises.	Procedure: Experimental: VESTIBULAR EXERCISE OCULAR AND MOVEMENT EXERCISES
Active Comparator: MULTICOMPONENT EXERCISE 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

Arm

Intervention/Treatment

Experimental: VESTIBULAR EXERCISE

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: Head and eye movements while sitting. Head and body movements while sitting. Paused exercises. Combined exercises of modifications on rungs, unstable surfaces and walking exercises.

Procedure: Experimental: VESTIBULAR EXERCISE

OCULAR AND MOVEMENT EXERCISES

Active Comparator: MULTICOMPONENT EXERCISE

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

Outcome Measures

Primary Outcome Measures

Movement Capacity: SPPB (Short Physical Performance Battery) Physical Function Valuation Battery [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
Speed test [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).
Test Time up and Go [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Seville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

MARINA LOPEZ GARCIA, Associate Professor, University of Seville

ClinicalTrials.gov Identifier:

NCT04690777

Other Study ID Numbers:

2410-N-19

First Posted:

Dec 31, 2020

Last Update Posted:

Dec 31, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 31, 2020