跳至主要内容
临床试验/NCT05134870
NCT05134870已完成不适用

Mimic-game & Groove: A TeleXercise Intervention to Get Active & Get Healthy

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Change in time during four-step square test

研究概览

简要总结

The composite effect of reduced balance, cognition, gait abnormalities/gait disturbances, and physical activity in older adults leads to fear of falling and decreased participation in daily activities, resulting in reduced cardiovascular fitness and deconditioning. Although many conventional balance and strength training programs have been implemented for older adults, these adults do not receive adequate practice dosage to make significant improvements, most likely due to lack of adherence to therapy and/or inadequate incorporation of all domains of the ICF model (body functions and structures, activities and participation) and lack of targeting cognitive-motor interference (deterioration of motor and/or cognitive function when both tasks are performed together). The use of TeleXercise via Tele rehabilitation has been found to be relatively enjoyable for older adults due to increased motivation and adherence to therapy, which led to the added improvement of physical and cognitive functioning. The overall aim of this pilot is to develop and test the Mimic-Me & Groove TeleXercise platform and then evaluate the compliance and efficacy of the TeleXercise intervention compared to control group receiving standard of care (education on conventional exercise and fall prevention program) for older adults as well as its effect on enhancing balance, gait, and cognition, and physical activity. Investigators also hope that the net effect of improvement in these domains of health outcomes will result in pre and post improvement in endurance and cardiovascular function and reduction of fall risk and improved quality of life of older adults. The study investigates the efficacy of a TeleXercise intervention in older adults by demonstrating its feasibility, compliance rate and also determine the efficacy of the Mimic-Me & Groove TeleXercise in improving health outcomes such as motor and cognitive functions, thereby reducing cognitive-motor interference. The study will also aim to determine the effectiveness of the TeleXercise in improving cardiovascular fitness and physical activity (PA) in older adults.

详细描述

Aging results in neuromuscular deterioration, such as impaired balance control, gait instability, and worsening cognition with increasing evidence pointing to the over-reliance on cognitive function to perform even simple motor tasks. Such deterioration has been shown to affect daily functional activities, quality of life, and cardiovascular fitness, along with an increase in the risk of falling. Physical activity has been recommended as a means to slow down neuromuscular deterioration and enhance gait, stability, and cognition in older adults. Further, increased levels of physical activity have also demonstrated positive effects on cardiovascular fitness (heart rate variability, HRV).However, older adults do not meet the recommended daily requirement (of at least 5000 steps/day) due to reduced motivation and lack of compliance to physical activity regimen. The lack of compliance may emanate from difficulty to commute to outpatient rehabilitation centers, lack of involvement, and the decreased participatory nature of most conventional physical therapy interventions. As a result, there is the need to implement a home-based TeleXercise intervention for older adults. This TeleXercise intervention should be motivational and enjoyable with increased participation or involvement, while aiming to improve cognition, physical activity and balance for fall prevention in older adults. Exercise training provided via Tele rehabilitation, as an alternative therapy, has shown to increase balance control and gait as well as increase motivation among older adults. Further, our preliminary studies conducted in the laboratory has shown promising results on various alternative methods for rehabilitating older adults. Among which exergaming-based dance therapy has exhibited feasibility in improving balance, mobility and cardiovascular function, along with decreasing fall risk. Also, older adults exhibit deterioration of balance control and gait in dual-task conditions (i.e., simultaneous performance of two tasks). Few systematic reviews have emphasized on some task-specific exercises to improve balance control in older adults, such as single leg stance, modified tree pose etc. Thus, it could be postulated that older adults could benefit from an integrated comprehensive therapy program which incorporates various physical exercises, such as conventional methods of balance exercises, exergaming-based balance games, and dance with cognitive training. However, there is no data on the feasibility and effect of such comprehensive therapy on efficacy, compliance, balance, cognitive, gait and physical activity measures among older adults. Given that older adults lack compliance to therapy, investigators therefore, seek to examine the feasibility of a comprehensive TeleXercise-based intervention through the use of a comprehensive intervention protocol incorporating various physical exercises. Specifically, task-specific balance training provided via observing and imitating an exercise activates Action Observation Network system (AON) and other brain centers, which is known to improve balance control through increased plasticity of neural systems (mirror neurons) for optimal observation and actual performance of movement.

Aim1: The study will test the applicability, feasibility and compliance of TeleXercise intervention (N=17) to improve physical function and reduce fall-risk in community-dwelling older adults.

Hypothesis: Participants will tolerate the training paradigm and will demonstrate significant improvements in balance, gait, cardiovascular and cognitive performance under single and dual-task conditions. Participants will also demonstrate appropriate compliance (attend >24/30 session) and motivation (>Intrinsic Motivation Inventory scores) post-intervention.

Aim 2: To examine if the proposed TeleXercise intervention will lead to higher cognitive function post-intervention.

Hypothesis: Participants will show significantly greater global cognitive function, executive and working memory and decreased cognitive-motor load post-training compared to pre-training

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age group: Community-dwelling healthy older adults between the age group of 55 - 85 years
  • Participants without any history of fracture for the last 1 year
  • Should have either a desktop computer/laptop/tablet and a WIFI connection.
  • Absence of any acute or chronic neurological (Stroke, Parkinson's disease, Alzheimer's disease), cardiopulmonary, musculoskeletal, or systemic diagnosis.
  • No recent major surgery (< 6 months) or hospitalization (< 3 months)
  • Not on any sedative drugs
  • Can understand and communicate in English

排除标准

  • Participants will not proceed with the study if at baseline measurement HR > 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age)
  • Inability to stand for at least 5 minutes without an assistive device (length of each exercise)
  • History of bone fracture or significant other systemic disease or surgery in the last six months
  • Uncontrolled acute medical, surgical, neurological or cardiovascular disease.
  • Moderate to severe cognitive impairment (MOCA <24/30)

结局指标

主要结局

Change in time during four-step square test

时间窗: Change in time from pre-test (Week 0) to post-training (week 5)

To test the dynamic balance and to assess the person's ability to step over objects forward, sideways, and backwards

Change in time during Sharpened Romberg

时间窗: Change in time from pre-test (Week 0) to post-training (week 5)

To assess the static balance of participants in sensory integration taxing condition

Change in time during 2-minute step in place test

时间窗: Change in time from pre-test (Week 0) to post-training (week 5)

To assess the cardiovascular exercise tolerance

Change in time during One-legged Stance test

时间窗: Change in time from pre-test (Week 0) to post-training (week 5)

To assess the static balance of participants in sensory integration taxing condition

Change in time during Tinetti Performance Oriented Mobility Assessment

时间窗: Change in time from pre-test (Week 0) to post-training (week 5)

To assess gait and balance together

Change in time during 30-second chair stand test.

时间窗: Change in time from pre-test (Week 0) to post-training (week 5)

This test is conducted to assess leg strength and endurance.

次要结局

  • Change in score of NASA Task Load Index scale (NASA-TLX)(Change in score from pre-test (Week 0) to post-training (week 5))
  • Change in correct response during Flanker inhibitory control and attention test(Change in number of correct response from pre-test (Week 0) to post-training (week 5))
  • Change in correct responses during Letter Number sequencing test(Change in number of correct response from pre-test (Week 0) to post-training (week 5))
  • Change in correct responses during Auditory stroop(Change in number of correct response from pre-test (Week 0) to post-training (week 5))
  • Change in correct response during Pattern comparison Processing speed test(Change in number of correct response from pre-test (Week 0) to post-training (week 5))
  • Change in score of Activities Specific Balance Confidence scale (ABC scale)(Change in score from pre-test (Week 0) to post-training (week 5))
  • Change in score of Community Integration Scale (CIS).(Change in score from pre-test (Week 0) to post-training (week 5))
  • Change in correct responses during Visual stroop test(Change in number of correct response from pre-test (Week 0) to post-training (week 5))
  • Change in score of Older People's Quality of Life Questionnaire (OPQOL-35)(Change in score from pre-test (Week 0) to post-training (week 5))
  • Change in score of Modified Borg Scale (MB)(Change in score from pre-test (Week 0) to post-training (week 5))
  • Change in correct response during List Sorting Memory test(Change in number of correct response from pre-test (Week 0) to post-training (week 5))
  • Change in correct response during Dimensional Change card sort test(Change in number of correct response from pre-test (Week 0) to post-training (week 5))
  • Change in score of Physical Activity Scale for elderly(Change in score from pre-test (Week 0) to post-training (week 5))

研究者

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

Tanvi Bhatt

PI

University of Illinois at Chicago

研究点 (2)

Loading locations...

相似试验