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

NCT ID: NCT04690777

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-04

Study Completion Date

2021-10-04

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.

Conditions

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Physical Therapy Sports Physical Therapy Exercise Therapy Gait

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

MULTICOMPONENT EXERCISE

Intervention Type PROCEDURE

exercises includes strengthening, cardiovascular training, flexibility and balance

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.

Group Type EXPERIMENTAL

Experimental: VESTIBULAR EXERCISE

Intervention Type PROCEDURE

OCULAR AND MOVEMENT EXERCISES

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.

Group Type EXPERIMENTAL

MULTICOMPONENT EXERCISE

Intervention Type PROCEDURE

exercises includes strengthening, cardiovascular training, flexibility and balance

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.

Group Type EXPERIMENTAL

Experimental: VESTIBULAR EXERCISE

Intervention Type PROCEDURE

OCULAR AND MOVEMENT EXERCISES

Interventions

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Experimental: VESTIBULAR EXERCISE

OCULAR AND MOVEMENT EXERCISES

Intervention Type PROCEDURE

MULTICOMPONENT EXERCISE

exercises includes strengthening, cardiovascular training, flexibility and balance

Intervention Type PROCEDURE

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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Seville

OTHER

Sponsor Role lead

Responsible Party

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MARINA LOPEZ GARCIA

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MARINA LOPEZ LOPEZ-GARCIA, PT

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Locations

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Fundomar Elderly nursing home

Seville, , Spain

Site Status

Countries

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Spain

References

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Iwasaki S, Yamasoba T. Dizziness and Imbalance in the Elderly: Age-related Decline in the Vestibular System. Aging Dis. 2014 Feb 9;6(1):38-47. doi: 10.14336/AD.2014.0128. eCollection 2015 Feb.

Reference Type BACKGROUND
PMID: 25657851 (View on PubMed)

Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.

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PMID: 19468085 (View on PubMed)

Agrawal Y, Zuniga MG, Davalos-Bichara M, Schubert MC, Walston JD, Hughes J, Carey JP. Decline in semicircular canal and otolith function with age. Otol Neurotol. 2012 Jul;33(5):832-9. doi: 10.1097/MAO.0b013e3182545061.

Reference Type BACKGROUND
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Brown KE, Whitney SL, Marchetti GF, Wrisley DM, Furman JM. Physical therapy for central vestibular dysfunction. Arch Phys Med Rehabil. 2006 Jan;87(1):76-81. doi: 10.1016/j.apmr.2005.08.003.

Reference Type BACKGROUND
PMID: 16401442 (View on PubMed)

Klatt BN, Ries JD, Dunlap PM, Whitney SL, Agrawal Y. Vestibular Physical Therapy in Individuals With Cognitive Impairment: A Theoretical Framework. J Neurol Phys Ther. 2019 Apr;43 Suppl 2(Suppl 2 Spec INTERNATIONAL CONFERENCE ON VESTIBULAR REHABILITATION):S14-S19. doi: 10.1097/NPT.0000000000000266.

Reference Type BACKGROUND
PMID: 30883488 (View on PubMed)

Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.

Reference Type BACKGROUND
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Swanenburg J, Wild K, Straumann D, de Bruin ED. Exergaming in a Moving Virtual World to Train Vestibular Functions and Gait; a Proof-of-Concept-Study With Older Adults. Front Physiol. 2018 Jul 31;9:988. doi: 10.3389/fphys.2018.00988. eCollection 2018.

Reference Type BACKGROUND
PMID: 30108511 (View on PubMed)

Martins E Silva DC, Bastos VH, de Oliveira Sanchez M, Nunes MK, Orsini M, Ribeiro P, Velasques B, Teixeira SS. Effects of vestibular rehabilitation in the elderly: a systematic review. Aging Clin Exp Res. 2016 Aug;28(4):599-606. doi: 10.1007/s40520-015-0479-0. Epub 2015 Oct 28.

Reference Type BACKGROUND
PMID: 26511625 (View on PubMed)

Baker MK, Atlantis E, Fiatarone Singh MA. Multi-modal exercise programs for older adults. Age Ageing. 2007 Jul;36(4):375-81. doi: 10.1093/ageing/afm054. Epub 2007 May 30.

Reference Type BACKGROUND
PMID: 17537741 (View on PubMed)

Beato M, Dawson N, Svien L, Wharton T. Examining the Effects of an Otago-Based Home Exercise Program on Falls and Fall Risks in an Assisted Living Facility. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):224-229. doi: 10.1519/JPT.0000000000000190.

Reference Type BACKGROUND
PMID: 29698252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29979352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32253894 (View on PubMed)

Gazzotti A, Meyer U, Freystaetter G, Palzer M, Theiler R, Abderhalden L, Bischoff-Ferrari HA. Physical performance among patients aged 70 + in acute care: a preliminar comparison between the Short Physical Performance Battery and the De Morton Mobility Index with regard to sensitivity to change and prediction of discharge destination. Aging Clin Exp Res. 2020 Apr;32(4):579-586. doi: 10.1007/s40520-019-01249-9. Epub 2019 Jul 8.

Reference Type BACKGROUND
PMID: 31286430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31208471 (View on PubMed)

Izquierdo M, Casas-Herrero A, Martinez-Velilla N, Alonso-Bouzon C, Rodriguez-Manas L; en representacion del Grupo de Investigadores. [An example of cooperation for implementing programs associated with the promotion of exercise in the frail elderly. European Erasmus + <<Vivifrail>> program]. Rev Esp Geriatr Gerontol. 2017 Mar-Apr;52(2):110-111. doi: 10.1016/j.regg.2016.03.004. Epub 2016 May 4. No abstract available. Spanish.

Reference Type BACKGROUND
PMID: 27132063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30977081 (View on PubMed)

Kundakci B, Sultana A, Taylor AJ, Alshehri MA. The effectiveness of exercise-based vestibular rehabilitation in adult patients with chronic dizziness: A systematic review. F1000Res. 2018 Mar 5;7:276. doi: 10.12688/f1000research.14089.1. eCollection 2018.

Reference Type BACKGROUND
PMID: 29862019 (View on PubMed)

Other Identifiers

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2410-N-19

Identifier Type: -

Identifier Source: org_study_id

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