Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05192564
Study type Interventional
Source University of the Basque Country (UPV/EHU)
Contact SARA MALDONADO-MARTIN, PhD
Phone +34945013534
Email sara.maldonado@ehu.eus
Status Recruiting
Phase N/A
Start date January 8, 2022
Completion date July 30, 2024

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04196933 - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Recruiting NCT04353115 - A Serious Game to Rehabilitate Gaze Stability in Children With Vestibular Deficit
Recruiting NCT04053829 - Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls N/A
Completed NCT03163901 - The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury N/A
Active, not recruiting NCT04479761 - Sensory Integration of Auditory and Visual Cues in Diverse Contexts N/A
Recruiting NCT03624283 - Interventions for Residual Dizziness After Successful Repositioning Maneuvers in Patients With BPPV N/A
Recruiting NCT03690817 - Hearing Loss, Vestibular Loss and Cognitive Performance
Completed NCT03555370 - Vestibular Treatment in Adolescents Following Sport Related Concussion N/A
Not yet recruiting NCT05322538 - Menier's Disease - Bone Density Study N/A
Completed NCT05795530 - Vestibular Function in Cochlear Implants
Completed NCT03330262 - Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability N/A
Not yet recruiting NCT06177132 - Vestibular Infant Screening - Rehabilitation N/A
Completed NCT03952936 - Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study N/A
Recruiting NCT05436067 - Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements N/A
Completed NCT03951584 - Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Active, not recruiting NCT05793216 - VestibulOTherapy: Vestibular Impact on Learning N/A
Recruiting NCT05741515 - Vestibular Balance Therapy Intervention for Children N/A
Recruiting NCT04851184 - Dose of Vestibular Rehabilitation for Vestibular Hypofunction N/A
Not yet recruiting NCT06300840 - Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH) N/A