Effects of Structured Exercise Program in Bilateral Vestibular Hypofunction

NCT05853562 | Completed DMC

• 1 other identifier: BVH_Structured_Exercise
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bilateral Vestibular Hypofunction

Keywords

Bilateral Vestibular Hypofunction; Dizziness; Kinesiophobia; Balance; Quality of Sleep; Quality of Life; Structured Exercise

Outcome Measures

Primary Outcomes (7)

• Visual Analog Scale

  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

  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

  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

  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

  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

  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

  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

Study Arms (3)

T0-T1 period

NO INTERVENTION

It was a control period. Participants were asked to continue their routine activities for 4 weeks.

T1-T2 period (structured vestibular rehabilitation program)

EXPERIMENTAL

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

T2-T3 period

ACTIVE COMPARATOR

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

Interventions

structured vestibular rehabilitation program OTHER

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.

T1-T2 period (structured vestibular rehabilitation program); T2-T3 period

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Miray Budak: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34820, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dizziness; Kinesiophobia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst Prof.

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 10, 2023
• Study Start: September 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

TU (1)