NCT02190045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 24, 2018

Completed
Last Updated

September 24, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

July 11, 2014

Results QC Date

January 23, 2018

Last Update Submit

January 23, 2018

Conditions

Gait, UnsteadyPostural Balance

Keywords

BalancegaitWii-Fit

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

Study Arms (2)

Wii-Fit program

EXPERIMENTAL

Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks

Other: Wii-Fit exercises

Cognitive remediation program

PLACEBO COMPARATOR

Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks

Other: Cognitive remediation exercises

Interventions

Wii-Fit exercisesOTHER

Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks

Wii-Fit program
Cognitive remediation exercisesOTHER

Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks

Cognitive remediation program

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Arkansas Veterans Healthcare System (3J/NLR)

North Little Rock, Arkansas, 72114, United States

Location

Related Publications (1)

  • 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.

    PMID: 28261500DERIVED

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kalpana Padala, MD
Organization
CAVHS/ UAMS
kppadala@uams.edu
501-257-1000

Study Officials

  • Kalpana Padala, MD

    Central Arkansas Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 15, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2016

Last Updated

September 24, 2018

Results First Posted

September 24, 2018

Record last verified: 2018-01

Locations

US(1)