Gait, Unsteady, Postural Balance
Conditions
Keywords
Balance, gait, Wii-Fit
Brief summary
Falls are a major public health problem. They are the leading cause of injuries and injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly. Despite the many proven benefits of exercise, many older adults in the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit as an exercise program.
Detailed description
Objectives/Rationale Falls are a major public health problem. They are the leading cause of injuries and injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly. Despite the many proven benefits of exercise, many older adults in the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit as an exercise program. Specific aims 1. To establish the safety, feasibility, and efficacy of an 8-week Wii-Fit program to improve measures of balance, and gait in older adults, compared to a cognitive remediation program, Brain fitness. 2. To compare the effect of an 8-week Wii-Fit program to Brain fitness program, on measures of biomechanical assessment, adherence, safety, physical activity, fear of fall, enjoyment, functional status, cognition and quality of life. Design 8-week, randomized, parallel group, active intervention study Methods Patients will be recruited via IRB approved flyers posted in various locations of the Little Rock and North Little Rock CAVHS campuses and via referrals from the CAVHS providers. Thirty elderly Veterans will be randomly assigned to Wii-Fit arm or Brain fitness arm. Both groups will participate in the intervention for approximately 45 minutes 3 days a week for 8 weeks. Outcome measures will be assessed at baseline, and approximately week 4 and after completion of week 8. Balance and gait will be assessed by Berg Balance Scale. Secondary outcome measures include biomechanical testing for gait and balance, Safety, Adherence, measures of functional status, cognition, quality of life, fear of falling, physical activity and physical activity enjoyment.
Interventions
OTHERWii-Fit exercises
Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks
OTHERCognitive remediation exercises
Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks
Sponsors
Central Arkansas Veterans Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Subjects age ≥ 60 years * Fall risk as measured by Berg Balance Scale (BBS) is ≤ 52 * Normal cognition as measured by Mini Mental State Exam (MMSE ≥ 24) * Able to consent
Exclusion criteria
* Subjects using wheel chair or walkers for mobility * Subjects with absolute contraindications per ACSM guidelines * Any medical condition (per the relative contraindications per ACSM guidelines below) that in the opinion of the study physician is likely to compromise their ability to safely participate in the exercise program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale | 8 weeks | The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from 0 (lowest level of function) to 4 (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device. |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life (SF-36) | 8 weeks |
| Functional Status Measures | 8 weeks |
| Activities Specific Balance Confidence Scale | 8 weeks |
| Modified Mini- Mental Exam | 8 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wii-Fit Program Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks | 15 |
| Cognitive Remediation Program Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Wii-Fit Program | Cognitive Remediation Program | Total |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 8.1 | 69.0 years STANDARD_DEVIATION 3.8 | 68.0 years STANDARD_DEVIATION 6.7 |
| Berg Balance Scale | 48.5 units on a scale STANDARD_DEVIATION 2.6 | 50.1 units on a scale STANDARD_DEVIATION 2.5 | 49.3 units on a scale STANDARD_DEVIATION 2.6 |
| Race/Ethnicity, Customized Race Non-Hispanic African American | 7 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Non-Hispanic Caucasian | 8 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Berg Balance Scale
The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from 0 (lowest level of function) to 4 (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wii-Fit Program | Berg Balance Scale | 48.5 units on a scale | Standard Deviation 2.6 |
| Cognitive Remediation Program | Berg Balance Scale | 50.1 units on a scale | Standard Deviation 2.5 |
Secondary
Activities Specific Balance Confidence Scale
Time frame: 8 weeks
Secondary
Functional Status Measures
Time frame: 8 weeks
Secondary
Modified Mini- Mental Exam
Time frame: 8 weeks
Secondary
Quality of Life (SF-36)
Time frame: 8 weeks