Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wii-Fit program | Experimental | Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks |
|
| Cognitive remediation program | Placebo Comparator | Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wii-Fit exercises | Other | Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (SF-36) | 8 weeks | |
| Functional Status Measures | 8 weeks | |
| Activities Specific Balance Confidence Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kalpana Padala, MD | Central Arkansas Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System (3J/NLR) | North Little Rock | Arkansas | 72114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28261500 | Derived | Padala KP, Padala PR, Lensing SY, Dennis RA, Bopp MM, Parkes CM, Garrison MK, Dubbert PM, Roberson PK, Sullivan DH. Efficacy of Wii-Fit on Static and Dynamic Balance in Community Dwelling Older Veterans: A Randomized Controlled Pilot Trial. J Aging Res. 2017;2017:4653635. doi: 10.1155/2017/4653635. Epub 2017 Feb 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Cognitive Remediation Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kalpana Padala, MD | CAVHS/ UAMS | 501-257-1000 | kppadala@uams.edu |
Not provided
| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cognitive remediation exercises | Other | Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks |
|
| 8 weeks |
| Modified Mini- Mental Exam | 8 weeks |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Berg Balance Scale | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 |
|
|
| Secondary | Quality of Life (SF-36) | Not Posted | 8 weeks | Participants |
| Secondary | Functional Status Measures | Not Posted | 8 weeks | Participants |
| Secondary | Activities Specific Balance Confidence Scale | Not Posted | 8 weeks | Participants |
| Secondary | Modified Mini- Mental Exam | Not Posted | 8 weeks | Participants |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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 | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided