Supervised Exercise as an Adjuvant Program in People With Chronic Bilateral or Unilateral Vestibular Hypofunction: EXERVEST Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Vestibular Disease
- Sponsor
- University of the Basque Country (UPV/EHU)
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Balance
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
SARA MALDONADO-MARTIN
Principal Investigator
University of the Basque Country (UPV/EHU)
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Cardiorespiratory fitness(8-week time)
- 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)
- Anxiety(8-week time)
- Physical activity and sedentary behaviour(8-week time)
- Assessment of gait, balance and risk of falls(8-week time)
- Waist circumference(8-week time)
- Body mass index (BMI)(8-week time)