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

Not Applicable

Completed

• Conditions: Physical Therapy; Sports Physical Therapy; Gait; Exercise Therapy
• Interventions: Procedure: MULTICOMPONENT EXERCISE

• Registration Number: NCT04690777
• Lead Sponsor: University of Seville

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.

Study Timeline

• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Study Start: 2021-07-04
• Primary Completion: 2021-09-12
• Study Completion: 2021-10-04
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MULTICOMPONENT EXERCISE at home telerehabilitaion	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.
multi component exercise in clinic	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.

Primary Outcome Measures

Name	Time	Method
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
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.
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).

Trial Locations

Locations (1)

Fundomar Elderly nursing home; 🇪🇸 Seville, Spain