NCT04894929

Brief Summary

14.44% of the Spanish population is over 70 years old and Aging as a normal process is characterized by gradual modifications in the physiological functions of the different systems, so that as age progresses, deterioration can lead to imbalances and alterations in health that cause diseases or traumatic processes. Within these processes, vestibular loss occurs normally in the face of healthy aging and, encompassed within this progressive dysfunction, various symptoms such as dizziness, imbalances, facial and limb weakness, confusion or headache may occur. Functional status is the best indicator of the overall health status of the elderly person. Identifying these indicators as soon as possible is the best way to prevent functional decline and promote active aging and life expectancy free of disability. For this reason, there are strategies that are currently a priority in health systems. The special COVID circumstances eliminate the possibility of group work and invite the realization at home or individually of workshops or collective exercises In the field of physiotherapy, vestibular exercises have shown efficacy for improving balance and reducing the risk of falls in cognitively intact people without vestibular impairment, being a specific approach to vestibular rehabilitation for the reduction of dizziness and imbalances , as it facilitates the compensation of the Central Nervous System. physiotherapy intervention has been shown in various studies to be effective in improving balance and reducing the risk of falls in older people. Also considering that the control of body balance in the elderly depends not only on the vestibular system, but also on the correlations between all the other systems, it seems interesting to add exercises with multiple components, since it would add effects of improvement in functional independence of people greater for daily activities and control of body balance. Therapeutic physical exercise is an effective non-pharmacological strategy to improve the functional condition of the elderly and although it is known that there are various exercise modalities that improve physical function and quality of life, The Clinical Practice Guidelines emphasize the importance of multicomponent / multimodal exercise for this population group

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

May 9, 2021

Last Update Submit

June 11, 2023

Conditions

Keywords

aging, physiotherapy, physical activity, balance

Outcome Measures

Primary Outcomes (3)

  • Barthel test

    balance

    _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)

  • VIDA test

    Questionnaire for Instrumental Activities of Daily Living (AIVD)

    _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)

  • short Performance Physical Battery (SPPB)

    Gait capacity: SPPB physical function assessment battery

    _measure 1: before start treatment _Measure 2: up to 6 weeks (after treatment)

Study Arms (2)

A. Multi-conponente exercise

EXPERIMENTAL

1. A 6-week therapeutic multi-component physical exercise program will be carried out. The ministerial guide will be followed by carrying out 5 weekly sessions (from Monday to Friday), offering the application through a web link of the weekly programming of the exercises for the patient (type of exercise, video of its execution, number of repetitions and description) having a approximate duration of 40 minutes. 2. Said sessions will be carried out daily and from the center a call was made at the end of the week to mark the follow-up and resolve any questions related to symptoms

Other: multi component exercise in the clinicOther: multi component exercise at home telerehabilitation

B. Vestibular exercise

EXPERIMENTAL

The vestibular exercises will be performed with the instructions of a physiotherapist, in sessions of about 20 minutes with 5 weekly sessions (Monday to Friday) consisting of 5 repetitions without fatigue of: to. Head and eye movements while sitting. b. Head and body movements while sitting. c. Exercises standing. d. Combined exercises of modifications in steps, unstable surfaces and in progress. and. Along with push up 30sec and squat 30sec All participants will have a weekly follow-up from Monday to Friday to control attendance and compliance via telephone.

Other: vestibular exercise in the clinicOther: vestibular exercise at home telerehabilitation

Interventions

Patients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform: 3 days of empowerment work, 4 days of flexibility work, and daily walking aerobic work and balance work.

A. Multi-conponente exercise

Patients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform. sessions of about 20 minutes with 5 weekly sessions (Monday to Friday) consisting of 5 repetitions without fatigue of: to. Head and eye movements while sitting. b. Head and body movements while sitting. c. Exercises standing. d. Combined exercises of modifications in steps, unstable surfaces and in progress. and. Along with push up 30sec and squat 30sec

B. Vestibular exercise

Patients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform with the help of a video. sessions of about 20 minutes with 5 weekly sessions (Monday to Friday) consisting of 5 repetitions without fatigue of: to. Head and eye movements while sitting. b. Head and body movements while sitting. c. Exercises standing. d. Combined exercises of modifications in steps, unstable surfaces and in progress. and. Along with push up 30sec and squat 30sec

B. Vestibular exercise

Patients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform with the help of a video: 3 days of empowerment work, 4 days of flexibility work, and daily walking aerobic work and balance work.

A. Multi-conponente exercise

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Women and men over 70 years old.
  • Having assessed through the VALINTAN (online free tool in primary care por comprehensive assessment of the elderly) of function their integral functional status and determining as a health process deterioration functional and lack of physical activity.
  • Subjects with a score between 4 and 9 points according to the "Short Physical Performance Battery" (SPPB) scale

You may not qualify if:

  • \- 1) patients without gait independence or who did not pass the previous evaluation in SPPB.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundomar Elderly nursing home

Seville, 41012, Spain

Location

Related Publications (17)

  • Kularbpthettong K. Effects of the Physical Therapy Application for Elderly. Advances in Intelligent Systems and Computing. 2020 Vol 1152: 462-467

    BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.

  • 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.

  • 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.

  • Macias JD, Massingale S, Gerkin RD. Efficacy of vestibular rehabilitation therapy in reducing falls. Otolaryngol Head Neck Surg. 2005 Sep;133(3):323-5. doi: 10.1016/j.otohns.2005.04.024.

  • 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.

  • 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.

  • Bean JF, Brown L, DeAngelis TR, Ellis T, Kumar VSS, Latham NK, Lawler D, Ni M, Perloff J. The Rehabilitation Enhancing Aging Through Connected Health Prehabilitation Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):1999-2005. doi: 10.1016/j.apmr.2019.04.015. Epub 2019 May 29.

  • 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.

  • Martin Lesende I, Mendibil Crespo LI, Berrizbeitia Gonzalez A, Llamosas Luengo I. [Computerized geriatric assessment tool VALINTAN (www.valintan.com) for primary care]. Aten Primaria. 2020 Oct;52(8):590-591. doi: 10.1016/j.aprim.2020.04.016. Epub 2020 Jun 15. No abstract available. Spanish.

  • de Hoyos Alonso MDC, Gorronogoitia Iturbe A, Martin Lesende I, Baena Diez JM, Lopez-Torres Hidalgo J, Magan Tapia P, Acosta Benito MA, Herreros Herreros Y; Grupo de Actividades Preventivas en los Mayores del PAPPS. Actividades preventivas en los mayores. Actualizacion PAPPS 2018. Aten Primaria. 2018 May;50 Suppl 1(Suppl 1):109-124. doi: 10.1016/S0212-6567(18)30365-2. No abstract available. Spanish.

Related Links

MeSH Terms

Conditions

Vestibular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesBehavior

Study Officials

  • Carmen Suárez Serrano, PT

    University of Seville

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
It has been explained to the patient that the exercises that they are going to perform are going to serve for their functional improvement, but the exercises are different depending on the group to which they have been assigned randomly.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: set of interventions can be carried out by making an initial diagnosis of pre-frailty or frailty using instruments and simple validated tests. This is indicated or thus recommended in the guidelines from national and international societies (24-25). In this sense, we can use a comprehensive assessment of the VALINTAN (computerized) tool, a VGI-type assessment, whose axis is function, focusing on predefined diagnoses associated with effective documented interventions or with functional fragility or loss. Currently the tool is open and freely accessible (26).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

May 9, 2021

First Posted

May 20, 2021

Study Start

September 30, 2021

Primary Completion

November 30, 2021

Study Completion

December 15, 2021

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

The intention is to publish in an impact magazine

Locations