Vestibular DiseaseEXERVESTNCT05192564
Exercise and Vestibular Hypofunction
A study testing Exercise for bilateral or unilateral vestibular hypofunction patients and Conventional rehabilitation treatment in people with Vestibular Disease and Vestibular Disorder, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Disease, Vestibular Disorder, Vestibular Vertigo
- What is being tested?
- Exercise for bilateral or unilateral vestibular hypofunction patients and Conventional rehabilitation treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2022to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Education and Sport
Vitoria-Gasteiz, Basque Country, 01007
SARA MALDONADO-MARTIN, PhD
ASIER LEKUE, MD
About this study
Official title: Supervised Exercise as an Adjuvant Program in People With Chronic Bilateral or Unilateral Vestibular Hypofunction: EXERVEST Study
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.
Read the detailed description
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.
- Conditions
- Vestibular Disease, Vestibular Disorder, Vestibular Vertigo
- Being tested
- Exercise for bilateral or unilateral vestibular hypofunction patients, Conventional rehabilitation treatment
- Keywords
- Vestibular hypofunction, Exercise, Balance training, Imbalance
- Medical subject headings
- Vestibular Diseases, Vertigo, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise for bilateral or unilateral vestibular hypofunction patientsOther
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.
Conventional rehabilitation treatmentOther
Vestibular rehabilitation exercises counseling
| Study group | Role | What they receive |
|---|---|---|
| EX Group | Experimental | Conventional rehabilitation treatment plus exercise intervention under the supervision of exercise specialists two non-consecutive days per week for eight weeks. Receives: 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 Receives: Other: Conventional rehabilitation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8-week time
Secondary outcomes (11)
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)
Measured: 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.
Measured: 8-week time
Physical activity level
Measured by accelerometry (8 days) in the non-dominant wrist.
Measured: 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.
Measured: 8-week time
Body composition
Biolectrical impedance for estimating % of body fat-mass, muscle-mass, and water.
Measured: 8-week time
Cardiorespiratory fitness
Peak Cardiopulmonary exercise test on bicycle ergometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8-week time
Waist circumference
Stand and place a tape measure around your middle, just above your hipbones. Measured in cm
Measured: 8-week time
Body mass index (BMI)
BMI is a person's weight in kilograms divided by the square of height in meters.
Measured: 8-week time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start8 Jan 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Vestibular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Collaborators
- Bioaraba Health Research Institute
- Responsible party
- Principal investigator, SARA MALDONADO-MARTIN, University of the Basque Country (UPV/EHU)
- Investigators
- SARA MALDONADO-MARTIN, PhD, Principal investigator, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192564
- Sponsor's protocol ID
- EXERcise+VESTibular (EXERVEST)
- Acronym
- EXERVEST
- Status last verified
- Apr 2023
- First submitted
- 25 Nov 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29081426Grill 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.
PubMed 30581415Morimoto 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.
PubMed 30691599Starkov 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.
PubMed 32767115van 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.
PubMed 27113255Visser 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.
PubMed 18789756Hillier 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.
PubMed 27406654Sulway S, Whitney SL. Advances in Vestibular Rehabilitation. Adv Otorhinolaryngol. 2019;82:164-169. doi: 10.1159/000490285. Epub 2019 Jan 15.
PubMed 30947180Kundakci 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.
PubMed 29862019Hall 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.
PubMed 26913496Dunlap 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.
PubMed 30461465Maslovara 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.
PubMed 30776020Meldrum 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.
PubMed 31385017Viziano 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.
PubMed 30012022Arnold 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.
PubMed 26111348
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Exercise as an Adjuvant Program in People With Chronic Bilateral or Unilateral Vestibular Hypofunction: EXERVEST Study
- ClinicalTrials.gov ID
- NCT05192564
- Acronym / sponsor ID
- EXERVEST / EXERcise+VESTibular (EXERVEST)
- Conditions
- Vestibular Disease, Vestibular Disorder, Vestibular Vertigo
- Keywords
- Vestibular hypofunction, Exercise, Balance training, Imbalance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Collaborators
- Bioaraba Health Research Institute
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| EX Group | Experimental | Other: Exercise for bilateral or unilateral vestibular hypofunction patients, Other: Conventional rehabilitation treatmentConventional 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 | Other: Conventional rehabilitation treatmentConventional rehabilitation treatment at home with unsupervised exercise intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise for bilateral or unilateral vestibular hypofunction patientsPhysical 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. | Other | EX Group |
| Conventional rehabilitation treatmentVestibular rehabilitation exercises counseling | Other | AC Group - ATTENTION CONTROL GROUP, EX Group |
Primary outcome
Balance
Time frame: 8-week time
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.
11 secondary outcomes
Health-related Quality of life
Time frame: 8-week time
Depression
Time frame: 8-week time
Physical activity level
Time frame: 8-week time
Blood pressure
Time frame: 8-week time
Body composition
Time frame: 8-week time
Cardiorespiratory fitness
Time frame: 8-week time
Anxiety
Time frame: 8-week time
Physical activity and sedentary behaviour
Time frame: 8-week time
Assessment of gait, balance and risk of falls
Time frame: 8-week time
Waist circumference
Time frame: 8-week time
Body mass index (BMI)
Time frame: 8-week time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 29081426Strupp 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.
- Background: PubMed 30581415Grill 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.
- Background: PubMed 30691599Morimoto 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.
- Background: PubMed 32767115Starkov 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.
- Background: PubMed 27113255van 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.
- Background: PubMed 18789756Visser 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.
- Background: PubMed 27406654Hillier 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.
- Background: PubMed 30947180Sulway S, Whitney SL. Advances in Vestibular Rehabilitation. Adv Otorhinolaryngol. 2019;82:164-169. doi: 10.1159/000490285. Epub 2019 Jan 15.
- Background: PubMed 29862019Kundakci 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.
- Background: PubMed 26913496Hall 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.
- Background: PubMed 30461465Dunlap 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.
- Background: PubMed 30776020Maslovara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SARA MALDONADO-MARTIN, PhD principal investigator
University of the Basque Country (UPV/EHU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise for bilateral or unilateral vestibular hypofunction patients and Conventional rehabilitation treatment in people with Vestibular Disease and Vestibular Disorder, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SARA MALDONADO-MARTIN, PhD (+34945013534, sara.maldonado@ehu.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 8-week time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05192564, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.