Clinical trial NCT05192564: Exercise and Vestibular Hypofunction
Official title: Supervised Exercise as an Adjuvant Program in People With Chronic Bilateral or Unilateral Vestibular Hypofunction: EXERVEST Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Disease
Vestibular Disorder
Vestibular Vertigo
Keywords: Vestibular hypofunction
Exercise
Balance training
Imbalance
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
Collaborators: name: Bioaraba
First posted: 2022-01-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.
* Have plans to be out of town for more than two weeks.

Primary outcomes:
measure: Balance
timeFrame: 8-week time
Secondary outcomes:
measure: Health-related Quality of life
timeFrame: 8-week time
measure: Depression
timeFrame: 8-week time
measure: Physical activity level
timeFrame: 8-week time
measure: Blood pressure
timeFrame: 8-week time
measure: Body composition
timeFrame: 8-week time
measure: Cardiorespiratory fitness
timeFrame: 8-week time
measure: Anxiety
timeFrame: 8-week time
measure: Physical activity and sedentary behaviour
timeFrame: 8-week time
measure: Assessment of gait, balance and risk of falls
timeFrame: 8-week time
measure: Waist circumference
timeFrame: 8-week time
measure: Body mass index (BMI)
timeFrame: 8-week time
Other outcomes:
Locations:
city: Vitoria-gasteiz
country: Spain
facility: Faculty of Education and Sport
state: Basque Country
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: SARA MALDONADO-MARTIN, PhD
role: PRINCIPAL_INVESTIGATOR
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