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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Physical Therapy, Sports Physical Therapy, Exercise Therapy, Gait

Intervention / Treatment
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* Procedure: Experimental: VESTIBULAR EXERCISE
* Procedure: MULTICOMPONENT EXERCISE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VESTIBULAR EXERCISE at home telerehabilitation<br>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<br>* OCULAR AND MOVEMENT EXERCISES<br>|
| Experimental: MULTICOMPONENT EXERCISE at home telerehabilitaion<br>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<br>* exercises includes strengthening, cardiovascular training, flexibility and balance<br>|
| Experimental: VESTIBULAR EXERCISE in clinic<br>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<br>* OCULAR AND MOVEMENT EXERCISES<br>|
| Experimental: multi component exercise in clinic<br>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<br>* exercises includes strengthening, cardiovascular training, flexibility and balance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Capacity: SPPB (Short Physical Performance Battery) Physical Function Valuation Battery | 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 | 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 | 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 |