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| Name | Class |
|---|---|
| Bioaraba Health Research Institute | NETWORK |
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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.
Interventional study with two randomized groups (attention control '[AC] and exercise group,[EX]) with assessment pre and post-intervention (8 weeks) and 6 months follow-up.
The AC group will perform only the home vestibular rehabilitation exercises that are usually prescribed in consultation with this type of patient, performing the same assessments as the intervention group in all phases of the study.
The participants in the EX group will exercise under the supervision of specialists in exercise and sports physical educators two non-consecutive days per week for eight weeks at the Faculty of Education and Sport of the University of the Basque Country (UPV/EHU). All sessions will start and end with blood pressure measurements and exercise intensity will be monitored by heart rate monitors (Polar Electro, Kempele, Finland) and through the original Borg scale (6-20). All sessions will include a 5-10 min warm-up with joint mobility exercises and gait technique and a 10 min cooldown with basic stretching exercises and controlled breathing. The main part of the session will consist of: 1) balance exercises, multidirectional displacements and strength with postural control, implementing 8-10 exercises integrating the main muscle groups and motor patterns, 2) aerobic exercise on bicycle (15 min) developed progressively in intensity (R1-mild, R2-moderate, R3-vigorous) implementing an intervallic design at low volume. The physical exercise intensity ranges (R1-mild, R2-moderate, R3-vigorous) will be defined on an individualized basis from the initial stress test and based on ventilatory thresholds. At the end of the intervention, participants will be provided with information on physical activity recommendations. Both intervention and control group patients will have all antivertiginous drugs withdrawn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EX Group | Experimental | Conventional rehabilitation treatment plus exercise intervention under the supervision of exercise specialists two non-consecutive days per week for eight weeks. |
|
| AC Group - ATTENTION CONTROL GROUP | Active Comparator | Conventional rehabilitation treatment at home with unsupervised exercise intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related Quality of life | Measured by Dizziness Handicap Inventory Questionnaire It contains a total score (100 items) and scores in the physical (28 items), functional (36 items) and emotional (36 items) subscales. Scores greater than 10 points should be referred to balance specialists for further evaluation. 16-34 Points (mild handicap) 36-52 Points (moderate handicap) 54+ Points (severe handicap) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SARA MALDONADO-MARTIN, PhD | Contact | +34945013534 | sara.maldonado@ehu.eus |
| Name | Affiliation | Role |
|---|---|---|
| SARA MALDONADO-MARTIN, PhD | University of the Basque Country (UPV/EHU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Education and Sport | Recruiting | Vitoria-Gasteiz | Basque Country | 01007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29081426 | Background | Strupp M, Kim JS, Murofushi T, Straumann D, Jen JC, Rosengren SM, Della Santina CC, Kingma H. Bilateral vestibulopathy: Diagnostic criteria Consensus document of the Classification Committee of the Barany Society. J Vestib Res. 2017;27(4):177-189. doi: 10.3233/VES-170619. | |
| 30581415 | Background | Grill E, Heuberger M, Strobl R, Saglam M, Holle R, Linkohr B, Ladwig KH, Peters A, Schneider E, Jahn K, Lehnen N. Prevalence, Determinants, and Consequences of Vestibular Hypofunction. Results From the KORA-FF4 Survey. Front Neurol. 2018 Dec 7;9:1076. doi: 10.3389/fneur.2018.01076. eCollection 2018. |
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| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D014717 | Vertigo |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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).
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|
| Conventional rehabilitation treatment | Other | Vestibular rehabilitation exercises counseling |
|
| 8-week time |
| Depression | Measured by Beck Depression Inventory (BDI) 21 Likert-type items. The maximum score is 63 points, with the following classification: 0-13, minimal depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression. | 8-week time |
| Physical activity level | Measured by accelerometry (8 days) in the non-dominant wrist. | 8-week time |
| Blood pressure | Ambulatory blood pressure monitoring (AMBP) is accomplished with a special device that consists of a blood pressure cuff that is worn on the arm and is attached to a small recording device that you wear on your belt. The participant will wear the ABPM device for 24 hours, and it records your blood pressure periodically (30-min intervals) throughout that period, during your routine daily activities and while you are sleeping. | 8-week time |
| Body composition | Biolectrical impedance for estimating % of body fat-mass, muscle-mass, and water. | 8-week time |
| Cardiorespiratory fitness | Peak Cardiopulmonary exercise test on bicycle ergometer. | 8-week time |
| Anxiety | Beck Anxiety Inventory (BAI). 21 items. The maximum score is 63 points, 25.7±11.4 being considered an anxiety score. | 8-week time |
| Physical activity and sedentary behaviour | International physical activity questionnaire (IPAQ) short-version. It consists of seven questions to capture average daily time spent sitting, walking, and engaging in moderate and vigorous PA over the last seven days. | 8-week time |
| Assessment of gait, balance and risk of falls | Dynamic Gait Index (DGI): composed of 8 exercises each scored from 0 (severe impairment) to 3 (highest level of functionality); maximum score: 24 points; a score < 19 is predictive of falls. | 8-week time |
| Waist circumference | Stand and place a tape measure around your middle, just above your hipbones. Measured in cm | 8-week time |
| Body mass index (BMI) | BMI is a person's weight in kilograms divided by the square of height in meters. | 8-week time |
| 30691599 | 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. |
| 32767115 | Background | Starkov D, Strupp M, Pleshkov M, Kingma H, van de Berg R. Diagnosing vestibular hypofunction: an update. J Neurol. 2021 Jan;268(1):377-385. doi: 10.1007/s00415-020-10139-4. Epub 2020 Aug 7. |
| 27113255 | Background | van Esch BF, Nobel-Hoff GE, van Benthem PP, van der Zaag-Loonen HJ, Bruintjes TD. Determining vestibular hypofunction: start with the video-head impulse test. Eur Arch Otorhinolaryngol. 2016 Nov;273(11):3733-3739. doi: 10.1007/s00405-016-4055-9. Epub 2016 Apr 25. |
| 18789756 | Background | Visser JE, Carpenter MG, van der Kooij H, Bloem BR. The clinical utility of posturography. Clin Neurophysiol. 2008 Nov;119(11):2424-36. doi: 10.1016/j.clinph.2008.07.220. Epub 2008 Sep 12. |
| 27406654 | Background | Hillier S, McDonnell M. Is vestibular rehabilitation effective in improving dizziness and function after unilateral peripheral vestibular hypofunction? An abridged version of a Cochrane Review. Eur J Phys Rehabil Med. 2016 Aug;52(4):541-56. Epub 2016 Jul 12. |
| 30947180 | Background | Sulway S, Whitney SL. Advances in Vestibular Rehabilitation. Adv Otorhinolaryngol. 2019;82:164-169. doi: 10.1159/000490285. Epub 2019 Jan 15. |
| 29862019 | Background | 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. |
| 26913496 | 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. |
| 30461465 | 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. |
| 30776020 | 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. |
| 31385017 | 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. |
| 30012022 | 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. |
| 26111348 | 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. |
| 22981400 | Background | 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. |
| 11388354 | 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. |
| 19707007 | 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. |
| 32235946 | Background | 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. |
| 31102020 | 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. |
| 37868660 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |