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

NCT04690777 | Completed

• 1 other identifier: 2410-N-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Physical Therapy; Sports Physical Therapy; Exercise Therapy; Gait

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

VESTIBULAR EXERCISE at home telerehabilitation

EXPERIMENTAL

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

MULTICOMPONENT EXERCISE at home telerehabilitaion

EXPERIMENTAL

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

VESTIBULAR EXERCISE in clinic

EXPERIMENTAL

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

multi component exercise in clinic

EXPERIMENTAL

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

Interventions

Experimental: VESTIBULAR EXERCISE PROCEDURE

OCULAR AND MOVEMENT EXERCISES

VESTIBULAR EXERCISE at home telerehabilitation; VESTIBULAR EXERCISE in clinic

MULTICOMPONENT EXERCISE PROCEDURE

exercises includes strengthening, cardiovascular training, flexibility and balance

MULTICOMPONENT EXERCISE at home telerehabilitaion; multi component exercise in clinic

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Fundomar Elderly nursing home

Seville, 41012, Spain

Location

Related Publications (17)

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  PMID: 30883488 BACKGROUND

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  PMID: 26913496 BACKGROUND

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  PMID: 29698252 BACKGROUND

• Fishleder S, Petrescu-Prahova M, Harris JR, Leroux B, Bennett K, Helfrich CD, Kohn M, Hannon P. Predictors of Improvement in Physical Function in Older Adults in an Evidence-Based Physical Activity Program (EnhanceFitness). J Geriatr Phys Ther. 2019 Oct/Dec;42(4):230-242. doi: 10.1519/JPT.0000000000000202.

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• Canli S, Ozyurda F. A multi-modal exercise intervention that improves cognitive function and physical performance, elderly with mobility-related disability: a randomized controlled trial. J Sports Med Phys Fitness. 2020 Jul;60(7):1027-1033. doi: 10.23736/S0022-4707.20.10286-X. Epub 2020 Apr 6.

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• Casas-Herrero A, Anton-Rodrigo I, Zambom-Ferraresi F, Saez de Asteasu ML, Martinez-Velilla N, Elexpuru-Estomba J, Marin-Epelde I, Ramon-Espinoza F, Petidier-Torregrosa R, Sanchez-Sanchez JL, Ibanez B, Izquierdo M. Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial. Trials. 2019 Jun 17;20(1):362. doi: 10.1186/s13063-019-3426-0.

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  PMID: 27132063 BACKGROUND

• Rossi-Izquierdo M, Gayoso-Diz P, Santos-Perez S, Del-Rio-Valeiras M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Lirola-Delgado A, Soto-Varela A. Prognostic factors that modify outcomes of vestibular rehabilitation in elderly patients with falls. Aging Clin Exp Res. 2020 Feb;32(2):223-228. doi: 10.1007/s40520-019-01185-8. Epub 2019 Apr 11.

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  PMID: 29862019 BACKGROUND

Study Officials

• MARINA LOPEZ LOPEZ-GARCIA, PT

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 31, 2020
• Study Start: July 4, 2021
• Primary Completion: September 12, 2021
• Study Completion: October 4, 2021
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)