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

Sports Physical Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690777
• Other study ID #: 2410-N-19
• Status: Completed
• Phase: N/A
• Start date: July 4, 2021
• Est. completion date: October 4, 2021

Study information

• Verified date: June 2023
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 4, 2021
• Est. primary completion date: September 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exercise Therapy
• Gait
• Physical Therapy
• Sports Physical Therapy

Intervention

Procedure:
• Experimental: VESTIBULAR EXERCISE
OCULAR AND MOVEMENT EXERCISES
• MULTICOMPONENT EXERCISE
exercises includes strengthening, cardiovascular training, flexibility and balance

Locations

Country	Name	City	State
Spain	Fundomar Elderly nursing home	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

References & Publications (17)

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. Erratum In: Arch Intern Med. 2009 Aug 10;169(15):1419. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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