A Phase II, Pilot-Randomized Clinical Trial to Study the Effect of a Novel Dual-Task Exercise Program for Balance, Mobility and Cognition in Community Dwelling Older Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Executive function
研究概览
简要总结
Goal:
The development of a Treadmill Rehabilitation Platform (TRP) for task-orientated rehabilitation that provides an adapted, blended approach among older adults with balance, mobility, and cognitive impairments.
Study Objective:
Examine the feasibility and benefits of a novel dual-task intervention to address mobility and cognitive decline with age using engaging interactive video games during treadmill walking and recumbent cycling.This will include evaluation of the effects of two interventions, one using treadmill walking and the second a recumbent cycle ergometer on
- Core balance
- Cardiac fitness, exercise endurance
- Gaze control
- Gait performance measure (walking stability and spatial-temporal gait parameters)
- Specific executive cognitive function (processing speed, cognitive inhibition, working memory)
- Dual task function during treadmill walking
Hypothesis:
- Dual-task exercise program will improve core balance and walking function to a greater extent in the Treadmill walking group compared to recumbent cycle group.
- Executive function will improve equally in both the treadmill walking and recumbent cycle group.
- Dual task exercise programs will have significant effect on gaze stability and cardiac fitness equally for both the treadmill and recumbent cycling groups.
详细描述
Study design: A phase II, Pilot-Randomized clinical trial. Sample size will be 15 volunteer older adults for each group, aged between 70-80 years old living in the community and attending the Reh-Fit center for exercise.
Method:
Recruitment:
Individuals attending the Reh-Fit center for exercise and physical activity. This will be coordinated and organized by staff at Reh-Fit center who will inform their members about this research study.
Interventions:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 70-80 years old.
- •Independent community dwelling
- •Walk 400 meters without a walking aid or using a single-point stick only.
- •Mini mental status test score greater than 24
- •Experiencing no more than one fall in the previous 12 months.
- •Having concerns about their balance which is based on participants' positive response to the question: "Are you concerned about your balance?"
- •Adequate hearing and vision
排除标准
- •Clinical diagnosis of dementia and a Mini Mental State Exam score less than 24,
- •Self-reported diagnosis or history of (i) stroke, traumatic brain injury or other neurological disorders such as Parkinson's disease and Vestibular disorders, (ii) cardiac disease, and (iii) muscular-skeletal injuries or orthopaedic diseases such as acute lower back or lower extremity pain, peripheral neuropathy, advanced hip/knee osteoporosis.
- •Any recent medical illness that would affect their balance or ability to walk for a period of at least 6 minutes.
研究组 & 干预措施
Experimental group
Dual Task Treadmill Walking Exercise Program
干预措施: Dual task treadmill walking exercise program (Behavioral)
Control group
Dual task recumbent cycling exercise program
干预措施: Dual task recumbent cycling exercise program (Behavioral)
结局指标
主要结局
Executive function
时间窗: Pre and post intervention of 10 weeks
Neuropsychological tests:Trail making test (A and B), Verbal Fluency, Visual Search and the dimensional change card sort test
Core Balance
时间窗: Pre and post intervention of 10 weeks
I t will be measured by performing a) Clinical Test of Sensory Integration of Balance and b) Five - Time Sit-to-Stand Test
Spatial - temporal gait variables
时间窗: Pre and post intervention of 10 weeks
It will be measured by asking the participants to walk on a treadmill for 2 minutes which is instrumented with a pressure mat at a speed of 0.9 m/s. Average and coefficient of variation will be obtained for the following parameters: swing time, step time, step length and step width.
Cardiac fitness
时间窗: Pre and post Intervention of 10 weeks
Cycle ergometer Submaximal Test will be performed measuring the heart rate, blood pressure, revolution per minute and rate of perceived exertion at an interval of 5 minutes.
Dual task function during walking
时间窗: Pre and post intervention of 10 weeks
Walking on at treadmill at a speed of 0.9 m/s while performing a cognitive game task simultaneously i.e the participants move a paddle (game sprite to catch bright circle objects(targets)moving vertically top to bottom, avoiding other shape(or colors) game objects (dis-tractors). This test game provides an objective quantification of cognitive functions like (i) Game success rate (percentage of target caught), (ii) average motor response time (time from appearance of the target to start of the paddle movement), (iii) average movement execution time (iv) movement efficiency .
次要结局
- 6- Minute walk test(Pre and post intervention of 10 weks)
- CHAMPS Questionnaire(Post intervention of 10 weeks)