Exercise and Vestibular Hypofunction

NCT05192564 | Unknown DMC

• 1 other identifier: EXERcise+VESTibular (EXERVEST)
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Vestibular hypofunction is a heterogeneous clinical entity that arises after a vestibular pathway injury, which if not properly compensated becomes chronic, and very often disabling, presenting with postural instability, blurred vision with cephalic movement, oscillopsia, and subjective sensation of dizziness and imbalance. People diagnosed with vestibular hypofunction, because of their clinical condition, often tend to reduce physical activity and lead to a sedentary life, despite the fact that exercise has been shown to improve postural stability, and it is a determining factor in recovery after vestibular injury. Physical activity improves the quality of life and reduces the risk of falls. Supervised exercise is, therefore, among the potentially beneficial adjuvant programs in this population, although little has been studied in comparison with other pathologies. Furthermore, in vestibular hypofunction, there is insufficient evidence on specific interventions in specific clinical situations, the amount of exercise, and the optimal duration of the programs. Therefore, the aims of the study are 1) to analyze the effects on balance by an 8-week period of a supervised exercise program in people with a diagnosis of bilateral or unilateral vestibular hypofunction and 2) to examine the effect of six-months detraining subsequent to intervention. Secondary objectives are to examine the additional effect of the intervention on health-related quality of life, psychological well-being, cardiorespiratory fitness, body composition, blood pressure, physical activity level, sedentary behavior, and sleep quality.

Conditions

Vestibular Disease; Vestibular Disorder; Vestibular Vertigo

Keywords

Vestibular hypofunction; Exercise; Balance training; Imbalance

Outcome Measures

Primary Outcomes (1)

• Balance

  Computerized Dynamic Posturography testing can objectively measure a patient's three sensory inputs at one time during the Sensory Oorganization Test. It can provide insight into where the balance disturbance may be developing from and more importantly, which one of the sensory inputs shows a problem. The human body uses three sensory inputs to maintain balance proper balance, they are: Vestibular (inner ear system), Somatosenory (feet, ankles, joints), Vision (eyes). These sensory inputs interact with the brain, which then drive and control our motor functions. Computerized Dynamic Posturography is a unique assessment technique used to objectively quantify and differentiate among these three sensory inputs, along with motor, and central adaptive impairments to balance control.

  8-week time

Secondary Outcomes (11)

• Health-related Quality of life

  8-week time

• Depression

  8-week time

• Physical activity level

  8-week time

• Blood pressure

  8-week time

• Body composition

  8-week time

Study Arms (2)

EX Group

EXPERIMENTAL

Conventional rehabilitation treatment plus exercise intervention under the supervision of exercise specialists two non-consecutive days per week for eight weeks.

Other: Exercise for bilateral or unilateral vestibular hypofunction patients; Other: Conventional rehabilitation treatment

AC Group - ATTENTION CONTROL GROUP

ACTIVE COMPARATOR

Conventional rehabilitation treatment at home with unsupervised exercise intervention

Other: Conventional rehabilitation treatment

Interventions

Exercise for bilateral or unilateral vestibular hypofunction patients OTHER

Physical Activity intervention with balance exercises, multidirectional displacements, and strength with postural control, implementing 8-10 exercises integrating the main muscle groups and motor patterns, aerobic exercise on bicycle (15 min) developed progressively in intensity (R1-mild, R2-moderate, R3-vigorous) implementing an intervallic design in low volume.

EX Group

Conventional rehabilitation treatment OTHER

Vestibular rehabilitation exercises counseling

AC Group - ATTENTION CONTROL GROUP; EX Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with bilateral or unilateral vestibular hypofunction.
• More than 6 months since the onset of vestibular hypofunction (chronic instability).
• Age over 18 years old.
• No previous rehabilitation treatment for vestibular hypofunction other than home exercises.

You may not qualify if:

• Fluctuating instability (not present every day).
• Recent onset instability (less than 6 months old, susceptible to complete clinical recovery).
• Current neurological pathology.
• History of neurosurgical disease, cerebrovascular disease, neurodegenerative disease or with central nervous system sequelae.
• Uncorrected ocular disorders.
• History of peripheral neuropathy in the lower extremities.
• Arthropathy or motor defects in lower limbs.
• Prolonged use of sedatives or vestibular suppressant medication.
• Significant medical disorders: including uncontrolled arterial hypertension, chronic or recurrent respiratory, neuromuscular or psychiatric diseases; musculoskeletal problems that interfere with physical exercise; immunodeficient diseases or a positive HIV test; anemia, blood disorders, chronic thrombotic disorders or hypercoagulant states; malignant tumors within the last five years, with the exception of therapeutically controlled skin cancer; any other disease that may be affected or aggravated by physical exercise.
• Being pregnant or breastfeeding.
• Have plans to be out of town for more than two weeks.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• Bioaraba: collaborator

Study Sites (1)

Faculty of Education and Sport

Vitoria-Gasteiz, Basque Country, 01007, Spain

RECRUITING

Related Publications (21)

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  PMID: 29081426 BACKGROUND

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  PMID: 30581415 BACKGROUND

• Morimoto H, Asai Y, Johnson EG, Koide Y, Niki J, Sakai S, Nakayama M, Kabaya K, Fukui A, Mizutani Y, Mizutani T, Ueki Y, Mizutani J, Ueki T, Wada I. Objective measures of physical activity in patients with chronic unilateral vestibular hypofunction, and its relationship to handicap, anxiety and postural stability. Auris Nasus Larynx. 2019 Feb;46(1):70-77. doi: 10.1016/j.anl.2018.06.010. Epub 2018 Jun 30.

  PMID: 30691599 BACKGROUND

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  PMID: 32767115 BACKGROUND

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• Sulway S, Whitney SL. Advances in Vestibular Rehabilitation. Adv Otorhinolaryngol. 2019;82:164-169. doi: 10.1159/000490285. Epub 2019 Jan 15.

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  PMID: 29862019 BACKGROUND

• 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.

  PMID: 26913496 BACKGROUND

• Dunlap PM, Holmberg JM, Whitney SL. Vestibular rehabilitation: advances in peripheral and central vestibular disorders. Curr Opin Neurol. 2019 Feb;32(1):137-144. doi: 10.1097/WCO.0000000000000632.

  PMID: 30461465 BACKGROUND

• Maslovara S, Butkovic-Soldo S, Peric M, Pajic Matic I, Sestak A. Effect of vestibular rehabilitation on recovery rate and functioning improvement in patients with chronic unilateral vestibular hypofunction and bilateral vestibular hypofunction. NeuroRehabilitation. 2019;44(1):95-102. doi: 10.3233/NRE-182524.

  PMID: 30776020 BACKGROUND

• Meldrum D, Jahn K. Gaze stabilisation exercises in vestibular rehabilitation: review of the evidence and recent clinical advances. J Neurol. 2019 Sep;266(Suppl 1):11-18. doi: 10.1007/s00415-019-09459-x. Epub 2019 Aug 5.

  PMID: 31385017 BACKGROUND

• Viziano A, Micarelli A, Augimeri I, Micarelli D, Alessandrini M. Long-term effects of vestibular rehabilitation and head-mounted gaming task procedure in unilateral vestibular hypofunction: a 12-month follow-up of a randomized controlled trial. Clin Rehabil. 2019 Jan;33(1):24-33. doi: 10.1177/0269215518788598. Epub 2018 Jul 16.

  PMID: 30012022 BACKGROUND

• Arnold SA, Stewart AM, Moor HM, Karl RC, Reneker JC. The Effectiveness of Vestibular Rehabilitation Interventions in Treating Unilateral Peripheral Vestibular Disorders: A Systematic Review. Physiother Res Int. 2017 Jul;22(3). doi: 10.1002/pri.1635. Epub 2015 Jun 25.

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• Balaban CD, Hoffer ME, Gottshall KR. Top-down approach to vestibular compensation: translational lessons from vestibular rehabilitation. Brain Res. 2012 Oct 30;1482:101-11. doi: 10.1016/j.brainres.2012.08.040. Epub 2012 Sep 6.

  PMID: 22981400 BACKGROUND

• Yardley L, Redfern MS. Psychological factors influencing recovery from balance disorders. J Anxiety Disord. 2001 Jan-Apr;15(1-2):107-19. doi: 10.1016/s0887-6185(00)00045-1.

  PMID: 11388354 BACKGROUND

• Ekwall A, Lindberg A, Magnusson M. Dizzy - why not take a walk? Low level physical activity improves quality of life among elderly with dizziness. Gerontology. 2009;55(6):652-9. doi: 10.1159/000235812. Epub 2009 Aug 25.

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• Smolka W, Smolka K, Markowski J, Pilch J, Piotrowska-Seweryn A, Zwierzchowska A. The efficacy of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction. Int J Occup Med Environ Health. 2020 Apr 30;33(3):273-282. doi: 10.13075/ijomeh.1896.01330. Epub 2020 Mar 26.

  PMID: 32235946 BACKGROUND

• Jahn K, Lopez C, Zwergal A, Zur O, Cakrt O, Kellerer S, Kerkeni H, Tjernstrom F, Meldrum D; Vestibular Rehabilitation Research Group in the European DIZZYNET. Vestibular rehabilitation therapy in Europe: chances and challenges. J Neurol. 2019 Sep;266(Suppl 1):9-10. doi: 10.1007/s00415-019-09368-z. Epub 2019 May 17. No abstract available.

  PMID: 31102020 BACKGROUND

• Ruiz-Rios M, Lekue A, Pinedo-Lopez J, Tous-Espelosin M, Arratibel-Imaz I, Garcia-Tabar I, Maldonado-Martin S. Supervised multicomponent exercise as an adjuvant program for people with unilateral and/or bilateral chronic vestibular hypofunction: EXERVEST study protocol. Contemp Clin Trials Commun. 2023 Oct 6;36:101213. doi: 10.1016/j.conctc.2023.101213. eCollection 2023 Dec.

  PMID: 37868660 DERIVED

MeSH Terms

Conditions

Vestibular Diseases; Vertigo; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• SARA MALDONADO-MARTIN, PhD

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SARA MALDONADO-MARTIN, PhD

CONTACT

+34945013534; sara.maldonado@ehu.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: DESIGN: Controlled, randomized, prospective, single-blind (staff of the otorhinolaryngology department) intervention study carried out in a cohort of patients (over 18 yr old) with a diagnosis of bilateral or unilateral vestibular hypofunction divided into two groups: intervention group with exercise + conventional rehabilitation treatment (EX group) and a group without intervention that will receive only conventional rehabilitation treatment (attention control group, AC).

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: January 14, 2022
• Study Start: January 8, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2024
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

ES (1)