Effects of Structured Exercise Program in Bilateral Vestibular Hypofunction

May 2, 2023 updated by: Miray Budak

Effects of Structured Exercise Program on Severity of Dizziness, Kinesiophobia, Balance, Fatigue, Quality of Sleep, Activities of Daily Living and Quality Of Life in Bilateral Vestibular Hypofunction

Background: The vestibular rehabilitation is an exercise-based method, aiming to maximize central nervous system(CNS) compensation at vestibular nuclear and other CNS levels for vestibular pathology. A minimal number of studies have documented the impact of Vestibular rehabilitation on the recovery rate of patients with Bilateral Vestibular Hypofunction(BVH).

Objective: The purpose of this study was to investigate the effectiveness of structured vestibular rehabilitation (VR) programs on severity of dizziness, kinesiophobia, balance, fatigue, quality of sleep, activities of daily living( ADL) and quality of life(QoL) in subjects with chronic BVH.

Method: Twenty-five participants diagnosed with BVH were included in the study. A structured VR program was applied in 50-minute sessions once a week and as a home exercise program 3 days a week over 8 weeks. Participants were evaluated for severity of dizziness with the Visual Analog Scale (VAS), for kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), for balance with the Semitandem, tandem, and standing tests, for quality of sleep with the Pittsburgh Sleep Quality Index (PSQI), for ADL with the Vestibular Disorders Activities of Daily Life (VADL), for QoL with Dizziness Handicap Inventory (DHI) and for fatigue with the Fatigue Severity Scale (FSS) at the baseline (T0), at 4th week (T1), 8th week (T2), and 20th week (T3) after study started.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Turkey
    • Beykoz
      • Istanbul, Beykoz, Turkey, 34820
        • Istanbul Medipol University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being between 20-80 years old
  • Diagnosed with bilateral peripheral vestibular hypofunction by videonystagmography
  • Have symptoms for more than three months from onset of illness

Exclusion Criteria:

  • having no symptoms of bilateral peripheral vestibular hypofunction
  • having Meniere's disease, vestibular migraine and other undulating vestibular disorders, cognitive, visual, neurological or general motor impairment
  • having previously received vestibular rehabilitation

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: T0-T1 period
It was a control period. Participants were asked to continue their routine activities for 4 weeks.
Experimental: T1-T2 period (structured vestibular rehabilitation program)
A structured vestibular rehabilitation program was applied in 50-minute sessions under the supervision of a physiotherapist once a week and as a home exercise program 3 days a week over 4 weeks.
Other: structured vestibular rehabilitation program
The structured Vestibular rehabilitation protocol consisted of a structured vestibular rehabilitation program that included vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises, and posture exercises.
Active Comparator: T2-T3 period
A structured vestibular rehabilitation program was applied in 50-minute sessions under the supervision of a physiotherapist once a week and as a home exercise program 3 days a week over 4 weeks. Afterwards, participants participated in the home program with telerehabilitation for 8 weeks.
Other: structured vestibular rehabilitation program
The structured Vestibular rehabilitation protocol consisted of a structured vestibular rehabilitation program that included vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises, and posture exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
It is a validated, subjective scale used to measure the intensity or frequency of various symptoms. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no symptom" on the left end (0 cm) of the scale and the "worst symptom" on the right end of the scale (10 cm). We used this scale to measure the severity of dizziness
Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
Tampa Scale of Kinesiophobia
Time Frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
It is a 17 items self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale ranges from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia
Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
Semitandem, Tandem, and Standing tests
Time Frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
Semitandem, Tandem, and Standing tests were used to evaluate balance. Semitandem test 30 , Tandem test 30 , Standing tests 30 Equilibrium times (sec) with eyes open-closed were recorded on hard and soft surfaces
Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
Pittsburgh Sleep Quality Index
Time Frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
It is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The seven component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality
Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
Dizziness Handicap Inventory
Time Frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
It is used to assess the impact of dizziness on quality of life. It consists of 25 clauses which determine the aggravating factors associated with dizziness and shakiness and also the emotional and functional results of vestibular system diseases. The inventory consists of 3 sub-dimensions, intended to determine physical, emotional and functional effects of the vestibular system diseases
Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
Fatigue Severity Scale
Time Frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
It was used to assess fatigue. There are 9 questions in the scale and each question consists of 7 points. An increase in the scale score indicates an increase in the level of fatigue. It detects the state of fatigue in the last month
Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
Vestibular Disorders Activities of Daily Life
Time Frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks
This scale is used to determine the degree of independence of patients with vestibular disorders, perceived inadequacies and vestibular complaints in daily activities. The scale consists of 28 items. The subscales are evaluated under three sub-headings as Functional-F- Ambulation-A- and Instrumental-E
Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks

Collaborators and Investigators

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

Sponsor

Miray Budak

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)

September 1, 2021

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVH_Structured_Exercise

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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