Clinical trial NCT05013671: Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls
Official title: Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: BPPV
Keywords: Benign Paroxysmal Positional Vertigo
vertigo
older adults
frailty
nursing home
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First, the nursing home resident will be assessed for the presence of BPPV. Based on the presence of BPPV, two groups will be formed: BPPV-group and control group. The residents suffering from BPPV will undergo balance tests and will be treated for their BPPV (BPPV-group). The nursing home residents with BPPV will be matched to residents without the disease (case control design) and will also undergo balance tests. At 1,3,6 and 12 months the presence of balance problems will be followed up in both groups.
Primary purpose: OTHER

Brief summary: BPPV is a benign condition of the balance organ, localized in the inner ear, in which calcium crystals loosen up and move freely in the endolymphatic fluid of the inner ear (more specifically in the semi-circular canals). During certain posture changes or head movements, these moving calcium crystals cause dizziness and balance problems. The general objective of the study is to evaluate the impact of BPPV on the balance of older adults in nursing homes. For this purpose, we will compare the balance of residents with BPPV with residents without BPPV. Furthermore, we will identify the impact of treatment on balance problems and fall risk in older adults in nursing homes.


Eligibility criteria: Inclusion Criteria:

* Institutionalized for at least 3 months
* Willing to participate
* Able to understand simple instructions
* Able to stand independently for 10 seconds (with the use of a walking aid)

Exclusion Criteria:

* Diagnosis of progressive neurological conditions resulting in a fast deterioration (i.e. amyotrophic lateral sclerosis or residents with palliative care)
* Participation in a rehabilitation program at the current time for a pathology of less than 6 months
* Contra-indication for vestibular testing such as heart failure or fear

Primary outcomes:
measure: The presence of BPPV
timeFrame: Baseline
measure: The presence of BPPV
timeFrame: Month 1
measure: The presence of BPPV
timeFrame: Month 3
measure: The presence of BPPV
timeFrame: Month 6
measure: The presence of BPPV
timeFrame: Month 12
measure: Dizziness Handicap Inventory
timeFrame: Baseline
measure: Dizziness Handicap Inventory
timeFrame: Month 1
measure: Dizziness Handicap Inventory
timeFrame: Month 3
measure: Dizziness Handicap Inventory
timeFrame: Month 6
measure: Dizziness Handicap Inventory
timeFrame: Month 12
measure: Falls Efficacy Scale International
timeFrame: Baseline
measure: Falls Efficacy Scale International
timeFrame: Month 1
measure: Falls Efficacy Scale International
timeFrame: Month 3
measure: Falls Efficacy Scale International
timeFrame: Month 6
measure: Falls Efficacy Scale International
timeFrame: Month 12
measure: Static balance
timeFrame: Baseline
measure: Static balance
timeFrame: Month 1
measure: Static balance
timeFrame: Month 3
measure: Static balance
timeFrame: Month 6
measure: Static balance
timeFrame: Month 12
measure: Timed up and Go (TUG)
timeFrame: Baseline
measure: Timed up and Go (TUG)
timeFrame: Month 1
measure: Timed up and Go (TUG)
timeFrame: Month 3
measure: Timed up and Go (TUG)
timeFrame: Month 6
measure: Timed up and Go (TUG)
timeFrame: Month 12
measure: 360° turn
timeFrame: Baseline
measure: 360° turn
timeFrame: month 1
measure: 360° turn
timeFrame: month 3
measure: 360° turn
timeFrame: month 6
measure: 360° turn
timeFrame: month 12
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: 10 meter walk test
timeFrame: Month 12
measure: Knee extensor strength
timeFrame: Baseline
measure: Knee extensor strength
timeFrame: Month 1
measure: Knee extensor strength
timeFrame: Month 3
measure: Knee extensor strength
timeFrame: Month 6
measure: Knee extensor strength
timeFrame: Month 12
Secondary outcomes:
measure: Fall incidents
timeFrame: Baseline
measure: Fall incidents
timeFrame: month 1
measure: Fall incidents
timeFrame: month 3
measure: Fall incidents
timeFrame: month 6
measure: Fall incidents
timeFrame: month 12
measure: Katz-ADL (retrospective data retrieved from patient files)
timeFrame: Baseline
measure: Katz-ADL (retrospective data retrieved from patient files)
timeFrame: Month 1
measure: Katz-ADL (retrospective data retrieved from patient files)
timeFrame: Month 3
measure: Katz-ADL (retrospective data retrieved from patient files)
timeFrame: Month 6
measure: Katz-ADL (retrospective data retrieved from patient files)
timeFrame: Month 12
measure: Medication (retrospective data retrieved from patient files)
timeFrame: Baseline
measure: Medication (retrospective data retrieved from patient files)
timeFrame: Month 1
measure: Medication (retrospective data retrieved from patient files)
timeFrame: Month 3
measure: Medication (retrospective data retrieved from patient files)
timeFrame: Month 6
measure: Medication (retrospective data retrieved from patient files)
timeFrame: Month 12
measure: Sleep pattern (retrospective data retrieved from patient files)
timeFrame: Baseline
measure: Sleep pattern (retrospective data retrieved from patient files)
timeFrame: Month 1
measure: Sleep pattern (retrospective data retrieved from patient files)
timeFrame: Month 3
measure: Sleep pattern (retrospective data retrieved from patient files)
timeFrame: Month 6
measure: Sleep pattern (retrospective data retrieved from patient files)
timeFrame: Month 12
measure: Comorbidities (retrospective data retrieved from patient files)
timeFrame: Baseline
measure: Comorbidities (retrospective data retrieved from patient files)
timeFrame: Month 1
measure: Comorbidities (retrospective data retrieved from patient files)
timeFrame: Month 3
measure: Comorbidities (retrospective data retrieved from patient files)
timeFrame: Month 6
measure: Comorbidities (retrospective data retrieved from patient files)
timeFrame: Month 12
measure: Nutrition (retrospective data retrieved from patient files)
timeFrame: Baseline
measure: Nutrition (retrospective data retrieved from patient files)
timeFrame: Month 1
measure: Nutrition (retrospective data retrieved from patient files)
timeFrame: Month 3
measure: Nutrition (retrospective data retrieved from patient files)
timeFrame: Month 6
measure: Nutrition (retrospective data retrieved from patient files)
timeFrame: Month 12
measure: Geriatric Depression Scale (GDS)
timeFrame: Baseline
measure: Geriatric Depression Scale (GDS)
timeFrame: Month 1
measure: Geriatric Depression Scale (GDS)
timeFrame: Month 3
measure: Geriatric Depression Scale (GDS)
timeFrame: Month 6
measure: Geriatric Depression Scale (GDS)
timeFrame: Month 12
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Month 1
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Month 3
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Month 6
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Month 12
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Baseline
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Month 1
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Month 3
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Month 6
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Month 12
measure: Frailty status
timeFrame: Baseline
measure: Frailty status
timeFrame: month 1
measure: Frailty status
timeFrame: month 3
measure: Frailty status
timeFrame: month 6
measure: Frailty status
timeFrame: month 12
Other outcomes:
Locations:
city: Leopoldsburg
country: Belgium
facility: WZC Leopoldspark
Study officials:
affiliation: Hasselt University
name: Joke Spildooren, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Laura Casters, drs.
role: STUDY_CHAIR
References: