Exercise and Vestibular Hypofunction

NCT ID: NCT05192564

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-08
• Study Completion Date: 2024-07-30

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.

Conditions

Vestibular Disease; Vestibular Disorder; Vestibular Vertigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EX Group

Conventional rehabilitation treatment plus exercise intervention under the supervision of exercise specialists two non-consecutive days per week for eight weeks.

Group Type: EXPERIMENTAL

Exercise for bilateral or unilateral vestibular hypofunction patients

Intervention Type: OTHER

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 treatment

Intervention Type: OTHER

Vestibular rehabilitation exercises counseling

AC Group - ATTENTION CONTROL GROUP

Conventional rehabilitation treatment at home with unsupervised exercise intervention

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation treatment

Intervention Type: OTHER

Vestibular rehabilitation exercises counseling

Interventions

Exercise for bilateral or unilateral vestibular hypofunction patients

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.

Intervention Type: OTHER

Conventional rehabilitation treatment

Vestibular rehabilitation exercises counseling

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioaraba

UNKNOWN

Sponsor Role: collaborator

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role: lead

Responsible Party

SARA MALDONADO-MARTIN

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SARA MALDONADO-MARTIN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Basque Country (UPV/EHU)

Locations

Faculty of Education and Sport

Vitoria-Gasteiz, Basque Country, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

SARA MALDONADO-MARTIN, PhD

Role: CONTACT

sara.maldonado@ehu.eus

+34945013534

Facility Contacts

SARA MALDONADO-MARTIN, PhD

Role: primary

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Other Identifiers

EXERcise+VESTibular (EXERVEST)

Identifier Type: -

Identifier Source: org_study_id