Clinical trial NCT05013684: Benign Paroxysmal Positional Vertigo in Older Adults
Official title: Benign Paroxysmal Positional Vertigo in Older Adults: Treatment Efficacy and the Impact on Balance, Inactivity and Frailty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2021-08-19
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the growing research on Benign Paroxysmal Positioning Vertigo (BPPV), the impact and treatment efficacy on balance, physical activity (and consequently) frailty in elderly is lacking. Also, the added value of the video Head Impulse Test (vHIT) in this population has never been studied before. With insights gained from this research, we hope to contribute to an efficient treatment of BPPV in this growing population and to minimize its impact and healthcare burden.


Eligibility criteria: Inclusion Criteria:

* Persons ≥ 65 years old
* Able to stand independent for at least 30 seconds
* Able to walk (with or without) walking aid for at least 10 meters
* Patients diagnosed with posterior semicircular canal BPPV
* Patients diagnosed with lateral-semicircular canal BPPV

Exclusion Criteria:

* Unable to understand and follow simple instructions (e.g. due to severe dementia, hearing loss or visual impairment)
* Persons temporarily or permanently living in a residential or psychiatric care centre, a home for the disabled or rehabilitation centre
* Persons with contra-indications for the diagnostic maneuver, vHIT or caloric irrigation test (e.g. severe limitation in mobility of the cervical spine of perforation of the tympanic membrane)
* Persons with other (acute) vestibular disorders and who as a result no longer meet the above mentioned diagnostic criteria for BPPV
* Persons with evolutionary disorders of the central nervous system (e.g. multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis).
* Persons who are already taking antivertigo drugs.
* Persons still in the rehabilitation phase after an orthopedic or cardiovascular incident.

Primary outcomes:
measure: The mini Balance Evalutation System test (miniBEStest)
timeFrame: baseline
measure: The mini Balance Evalutation System test (miniBEStest)
timeFrame: month 1
measure: The mini Balance Evalutation System test (miniBEStest)
timeFrame: month 3
measure: The mini Balance Evalutation System test (miniBEStest)
timeFrame: month 6
measure: 10 meter walk test
timeFrame: Baseline
measure: 10 meter walk test
timeFrame: month 1
measure: 10 meter walk test
timeFrame: month 3
measure: 10 meter walk test
timeFrame: month 6
measure: physical activity level measurde by an accelerometer (MOX)
timeFrame: baseline
measure: physical activity level measurde by an accelerometer (MOX)
timeFrame: month 1
measure: physical activity level measurde by an accelerometer (MOX)
timeFrame: month 3
measure: physical activity level measurde by an accelerometer (MOX)
timeFrame: month 6
measure: The International Physical Activity Questionnaire
timeFrame: Baseline
measure: The International Physical Activity Questionnaire
timeFrame: Month 1
measure: The International Physical Activity Questionnaire
timeFrame: Month 3
measure: The International Physical Activity Questionnaire
timeFrame: Month 6
measure: Frailty
timeFrame: baseline
measure: Frailty
timeFrame: month 1
measure: Frailty
timeFrame: month 3
measure: Frailty
timeFrame: month 6
Secondary outcomes:
measure: the Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline
measure: the 15-item Geriatric Depression Scale
timeFrame: baseline
measure: the 15-item Geriatric Depression Scale
timeFrame: Month 1
measure: the 15-item Geriatric Depression Scale
timeFrame: Month 3
measure: the 15-item Geriatric Depression Scale
timeFrame: Month 6
measure: Age
timeFrame: Throug study completion, an average of 6 months
measure: Height
timeFrame: Throug study completion, an average of 6 months
measure: BPPV-symptomatology
timeFrame: Throug study completion, an average of 6 months
measure: medication use
timeFrame: Throug study completion, an average of 6 months
measure: Living situation
timeFrame: Throug study completion, an average of 6 months
measure: Walking aid
timeFrame: Throug study completion, an average of 6 months
measure: Fall history
timeFrame: Up to the end of the study
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Hasselt University
name: Joke Spildooren, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Sara Pauwels, drs.
role: STUDY_CHAIR
References: