An interventional study of Exercise for bilateral or unilateral vestibular hypofunction patients and Conventional rehabilitation treatment in Vestibular Disease, Vestibular Disorder and Vestibular Vertigo, sponsored by University of the Basque Country (UPV/EHU). Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by University of the Basque Country (UPV/EHU) · Not applicable, Interventional, and Treatment
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.
248 studies on the registry are indexed under Vertigo; 39 are open to participants now.
This study's planned enrollment of 78 is above the median of 57 across 186 interventional studies indexed under Vertigo.
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Exclusion Criteria:
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
Conventional rehabilitation treatment at home with unsupervised exercise intervention
Other: Conventional rehabilitation treatment
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.
Vestibular rehabilitation exercises counseling
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.
Time frame: 8-week time
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)
Time frame: 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.
Time frame: 8-week time
Physical activity level
Measured by accelerometry (8 days) in the non-dominant wrist.
Time frame: 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.
Time frame: 8-week time
Body composition
Biolectrical impedance for estimating % of body fat-mass, muscle-mass, and water.
Time frame: 8-week time
Cardiorespiratory fitness
Peak Cardiopulmonary exercise test on bicycle ergometer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8-week time
Waist circumference
Stand and place a tape measure around your middle, just above your hipbones. Measured in cm
Time frame: 8-week time
Body mass index (BMI)
BMI is a person's weight in kilograms divided by the square of height in meters.
Time frame: 8-week time
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University of the Basque Country (UPV/EHU)