Wii-Fit For Balance And Gait In Elderly Veterans

• Sponsor: Central Arkansas Veterans Healthcare System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02190045
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gait, Unsteady; Postural Balance	Other: Wii-Fit exercises; Other: Cognitive remediation exercises	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Wii-Fit For Balance And Gait In Elderly Veterans
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wii-Fit program Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks	Other: Wii-Fit exercises; Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks
Placebo Comparator: Cognitive remediation program Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks	Other: Cognitive remediation exercises; Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Quality of Life (SF-36) [8 weeks]

2. Functional Status Measures [8 weeks]

3. Activities Specific Balance Confidence Scale [8 weeks]

4. Modified Mini- Mental Exam [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Arkansas Veterans Healthcare System (3J/NLR)	North Little Rock	Arkansas	United States	72114

Sponsors and Collaborators

• Central Arkansas Veterans Healthcare System

Investigators

• Principal Investigator: Kalpana Padala, MD, Central Arkansas Veterans Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kalpana Padala, MD, Staff Physician, Central Arkansas Veterans Healthcare System
• ClinicalTrials.gov Identifier: NCT02190045
• Other Study ID Numbers: 404039
• First Posted: Jul 15, 2014
• Last Update Posted: Sep 24, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Kalpana Padala, MD, Staff Physician, Central Arkansas Veterans Healthcare System: Balance; gait; Wii-Fit
• Additional relevant MeSH terms: Gait Disorders, Neurologic

Study Results

Participant Flow

Arm/Group Title	Wii-Fit Program	Cognitive Remediation Program
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	15	15
COMPLETED	12	15
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Wii-Fit Program	Cognitive Remediation Program	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.5 (8.1)	69.0 (3.8)	68.0 (6.7)
Sex: Female, Male (Count of Participants)
Female	2 13.3%	2 13.3%	4 13.3%
Male	13 86.7%	13 86.7%	26 86.7%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic Caucasian	8 53.3%	12 80%	20 66.7%
Non-Hispanic African American	7 46.7%	3 20%	10 33.3%
Berg Balance Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	48.5 (2.6)	50.1 (2.5)	49.3 (2.6)

Outcome Measures

1. Primary Outcome

Title	Berg Balance Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wii-Fit Program	Cognitive Remediation Program
Arm/Group Description	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	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
Measure Participants	15	15
Mean (Standard Deviation) [units on a scale]	48.5 (2.6)	50.1 (2.5)

2. Secondary Outcome

Title	Quality of Life (SF-36)
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Functional Status Measures
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Activities Specific Balance Confidence Scale
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Modified Mini- Mental Exam
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Wii-Fit Program		Cognitive Remediation Program
Arm/Group Description	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		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
All Cause Mortality
	Wii-Fit Program		Cognitive Remediation Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Wii-Fit Program		Cognitive Remediation Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Wii-Fit Program		Cognitive Remediation Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.