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临床试验/NCT02190045
NCT02190045已完成不适用

Wii-Fit For Balance And Gait In Elderly Veterans

Central Arkansas Veterans Healthcare System2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Berg Balance Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Wii-Fit program

Experimental

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

干预措施: Wii-Fit exercises (Other)

Cognitive remediation program

Placebo Comparator

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

干预措施: Cognitive remediation exercises (Other)

结局指标

主要结局

Berg Balance Scale

时间窗: 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.

次要结局

  • Quality of Life (SF-36)(8 weeks)
  • Modified Mini- Mental Exam(8 weeks)
  • Functional Status Measures(8 weeks)
  • Activities Specific Balance Confidence Scale(8 weeks)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Kalpana Padala, MD

Staff Physician

Central Arkansas Veterans Healthcare System

研究点 (2)

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