Exercise and Vestibular Hypofunction (EXERVEST)

April 12, 2023 updated by: SARA MALDONADO-MARTIN, University of the Basque Country (UPV/EHU)

Supervised Exercise as an Adjuvant Program in People With Chronic Bilateral or Unilateral Vestibular Hypofunction: EXERVEST Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Basque Country
      • Vitoria-gasteiz, Basque Country, Spain, 01007
        • Recruiting
        • Faculty of Education and Sport
        • Contact:
          • SARA MALDONADO-MARTIN, PhD
        • Principal Investigator:
          • ASIER LEKUE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EX Group
Conventional rehabilitation treatment plus exercise intervention under the supervision of exercise specialists two non-consecutive days per week for eight weeks.
Other: Conventional rehabilitation treatment
Vestibular rehabilitation exercises counseling
Other: 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.
Active Comparator: AC Group - ATTENTION CONTROL GROUP
Conventional rehabilitation treatment at home with unsupervised exercise intervention
Other: Conventional rehabilitation treatment
Vestibular rehabilitation exercises counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8-week time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of life
Time Frame: 8-week time

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)
8-week time
Depression
Time Frame: 8-week time
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.
8-week time
Anxiety
Time Frame: 8-week time
Beck Anxiety Inventory (BAI). 21 items. The maximum score is 63 points, 25.7±11.4 being considered an anxiety score.
8-week time
Physical activity and sedentary behaviour
Time Frame: 8-week time
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.
8-week time
Assessment of gait, balance and risk of falls
Time Frame: 8-week time
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.
8-week time
Waist circumference
Time Frame: 8-week time
Stand and place a tape measure around your middle, just above your hipbones. Measured in cm
8-week time
Body mass index (BMI)
Time Frame: 8-week time
BMI is a person's weight in kilograms divided by the square of height in meters.
8-week time
Physical activity level
Time Frame: 8-week time
Measured by accelerometry (8 days) in the non-dominant wrist.
8-week time
Blood pressure
Time Frame: 8-week time
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.
8-week time
Body composition
Time Frame: 8-week time
Biolectrical impedance for estimating % of body fat-mass, muscle-mass, and water.
8-week time
Cardiorespiratory fitness
Time Frame: 8-week time
Peak Cardiopulmonary exercise test on bicycle ergometer.
8-week time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Basque Country (UPV/EHU)

Collaborators

Bioaraba

Investigators

  • Principal Investigator: SARA MALDONADO-MARTIN, PhD, University of the Basque Country (UPV/EHU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

July 30, 2024

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

December 31, 2021

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXERcise+VESTibular (EXERVEST)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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