Dizziness
Conditions
Keywords
Dizziness, Geriatrics, Rehabilitation, Vestibular rehabilitation
Brief summary
The purpose of this study is to develop effective exercise intervention to reduce dizziness and fall risk in older adults with non-specific dizziness. We hypothesize that the use of vestibular exercises can reduce dizziness and improve gaze and postural stability in older persons.
Detailed description
Community dwelling older individuals who present to a specialty dizziness clinic (Atlanta VAMC or Emory University) with a primary complaint of dizziness will be recruited to participate in this study. Before beginning the study, the presence of normal vestibular function will be measured directly using standard vestibular function tests. Individuals will be randomly assigned to the vestibular exercise group (VR) or to the control group (CON). Data will be collected prior to the initiation of physical therapy and at the completion of the 6-week intervention period. The VR group will perform vestibular exercises plus balance and gait exercises. The CON group will perform saccadic eye movements without targets against a blank wall, as well as balance and gait exercises. The balance and gait exercises for each group will be based on identified impairments and functional limitations, as is the standard of care in physical therapy. All subjects within a group will follow the same exercise progression for the vestibular or eye movement exercises. Subjects will be seen in the clinic on a weekly basis to review and modify the exercises according to a standard protocol and to reinforce compliance.
Interventions
BEHAVIORALVestibular rehabilitation
vestibular adaptation and substitution exercises
BEHAVIORALPlacebo
placebo vestibular exercises
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must be at least 60 years of age, seeking medical care due to dizziness and have normal vestibular function based on results of the clinical examination, rotary chair and/or caloric tests.
Exclusion criteria
Abnormal vestibular function based on results of clinical examination, rotary chair and/or caloric tests.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index | 6 weeks | Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of \< 20 indicates risk for falling. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Visual Acuity | 6 weeks | Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vestibular Rehabilitation vestibular exercises plus standard balance and gait exercises
Vestibular rehabilitation: vestibular adaptation and substitution exercises | 20 |
| Placebo placebo exercises plus standard balance and gait exercises
Placebo Vestibular rehabilitation: placebo vestibular exercises | 17 |
| Total | 37 |
Baseline characteristics
| Characteristic | Placebo | Total | Vestibular Rehabilitation |
|---|---|---|---|
| Age, Continuous | 74.5 years STANDARD_DEVIATION 8.5 | 73.8 years STANDARD_DEVIATION 7.5 | 73.6 years STANDARD_DEVIATION 6.5 |
| Dynamic Gait Index | 16.1 units on a scale STANDARD_DEVIATION 2.6 | 15.1 units on a scale STANDARD_DEVIATION 3 | 14.2 units on a scale STANDARD_DEVIATION 3.1 |
| Dynamic Visual Acuity | 0.14 LogMAR STANDARD_DEVIATION 0.07 | 0.16 LogMAR STANDARD_DEVIATION 0.08 | 0.20 LogMAR STANDARD_DEVIATION 0.08 |
| Sex: Female, Male Female | 11 Participants | 28 Participants | 17 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
Dynamic Gait Index
Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of \< 20 indicates risk for falling.
Time frame: 6 weeks
Population: Per-protocol analyses (i.e., only subjects who completed the intervention were included).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vestibular Rehabilitation | Dynamic Gait Index | Discharge (6 weeks) | 18.9 units on a scale | Standard Deviation 1.8 |
| Vestibular Rehabilitation | Dynamic Gait Index | Baseline | 14.2 units on a scale | Standard Deviation 3.1 |
| Placebo | Dynamic Gait Index | Discharge (6 weeks) | 18.9 units on a scale | Standard Deviation 3 |
| Placebo | Dynamic Gait Index | Baseline | 16.1 units on a scale | Standard Deviation 2.6 |
p-value: 0.026RM ANOVA
p-value: <0.001RM ANOVA
p-value: >0.05RM ANOVA
Secondary
Dynamic Visual Acuity
Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vestibular Rehabilitation | Dynamic Visual Acuity | Discharge (6 weeks) | 0.14 LogMAR | Standard Deviation 0.07 |
| Vestibular Rehabilitation | Dynamic Visual Acuity | Baseline | 0.20 LogMAR | Standard Deviation 0.08 |
| Placebo | Dynamic Visual Acuity | Discharge (6 weeks) | 0.19 LogMAR | Standard Deviation 0.08 |
| Placebo | Dynamic Visual Acuity | Baseline | 0.21 LogMAR | Standard Deviation 0.1 |
p-value: >0.05RM ANOVA
p-value: 0.016RM ANOVA
p-value: >0.05RM ANOVA