跳至主要内容
临床试验/NCT05198232
NCT05198232已完成不适用

The Effects of Virtual Low-Tempo and High-Tempo Zumba® in Individuals With Developmental Disabilities on Functional Mobility, Aerobic Capacity, Inhibitory Control, Attention, and Balance

Auburn University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年1月26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
57
试验地点
2
主要终点
Change in Cardiorespiratory functioning using the 6-minute Walk Test (6MWT)

研究概览

简要总结

There are critical knowledge gaps that need to be addressed to understand the impact of aerobic exercise programs on relevant functional outcomes in adults with developmental disabilities (DD). This study will build upon previous literature by examining the impact of a 10-week (2x a week; 60-minutes per session) virtual adapted aerobic dance intervention (adapted Zumba®) in adults with DD ages 20-69 (n=58). Participants will be quasi-randomized to one of three groups: control (normal activities), low-tempo Zumba®, and high-tempo Zumba®. The quasi-randomization enables the investigators to ensure similarities in relevant demographic factors (e.g., disability type, age, sex) across the three groups. This design will enable the investigators to determine the effects of Zumba® and the impact of tempo level on relevant outcome measures. Participants will compete testing three times - pre-test, post-test, and a 4-week follow-up test - to determine the immediate and long-term benefits of Zumba®. Changes in functional mobility (Timed Up-And-Go), balance (Clinical Test of Sensory Interaction on Balance), aerobic capacity (6-minute Walk Test), and executive functioning (Flanker) will be assessed. During the program, participants' moderate-to-vigorous physical activity (MVPA) will be measured using accelerometry. Compared to the control group, the investigators hypothesize that both Zumba groups will show an improvement in body composition, balance, functional mobility, executive functioning, aerobic capacity, and MVPA during the program. Moreover, the investigators hypothesize that the high tempo group will improve body composition, balance, functional mobility, executive functioning, aerobic capacity, and MVPA during the program more than the low tempo.

详细描述

The term developmental disabilities (DD) encompasses a group of long-term disabilities that begin before the age of 18 years and include autism spectrum disorder (ASD), cerebral palsy (CP), Down syndrome (DS), intellectual disabilities (ID), and other similar disabilities. Currently, nearly 17% of children have a DD. Furthermore, the prevalence of DD has grown over the last 8 years; the prevalence of ID and DS has increased by more than 25% (from 2009-2017), and ASD has doubled over this period. Simultaneously, the life expectancy of those with DS has also increased to into the sixties and for those with ID into their seventies creating a growing population of older adults with DD. Despite the increase in life expectancy, individuals with DS and ID do not live as long as typically developing individuals and have a lower quality of life throughout the lifespan. Therefore, interventions are needed to improve the health and quality of life in adults with DD.

Individuals with DD face disproportionate physical health problems. Low cardiorespiratory fitness, low physical activity (PA) levels, poor functional mobility, and greater obesity. Together, these issues lead to secondary health conditions that contribute to early morbidity and reduced quality of life for the growing population of adults with DD. In fact, one study found that two of the leading causes of death for individuals with DD, heart disease and diabetes, were correlated with low levels of PA.

Access to adapted PA and fitness programs may attenuate the risk for health problems, poor quality of life, and early morbidity in this population. Indeed, older adults (>50 years old) with ID with high fitness skills (i.e., cardiorespiratory fitness, grip strength, balance) have much high survival rates over a 5-year period than those with low fitness skills. Indeed, aerobic, strengthening, and combined exercise programs have been found to improve the overall health and well-being of adults (ages 18-75) with ID. Thus, there is a clear need to develop and implement exercise and fitness programs to promote healthy aging and reduce physical health disparities in this underserved population.

Aerobic exercise programs have been found to improve cardiorespiratory fitness, strength, flexibility, mobility, and attention in individuals with DD. However, there are several important limitations that suggest the need for further study. First, many previous studies investigating the efficacy of aerobic programs in individuals with DD did not employ randomized control designs, which reduces the generalizability and increases the bias of study results. If there was a control group, the controls consisted of inactive controls. Rather, the use of active control groups helps to determine how different components of the exercise program (e.g., frequency, intensity, time, or type) impact outcomes. Second, few studies have examined the impact of aerobic exercise programs on functional mobility or balance and attention in adults with DD. These two variables are relevant for the ability to perform activities of daily living independently. Third, few studies have included a retention period to examine the long-term impact of aerobic exercise programs (i.e., beyond the immediate effects of an exercise program) in this population. Lastly, only two studies examined the impact of cognitively-engaging aerobic exercise programs like Zumba® in individuals with DD. Cognitively-engaging aerobic exercise programs may confer a greater impact on cognitive functions like attention compared to typical aerobic exercise programs (e.g., running, cycling, etc.).

Given the limitations of previous studies, there are critical knowledge gaps that need to be addressed to understand the impact of aerobic exercise programs on relevant functional outcomes in adults with developmental disabilities (DD). This study will build upon previous literature by examining the impact of a virtual 10-week (2x a week; 60-minutes per session) adapted aerobic dance intervention (adapted Zumba®) in adults with DD ages 19.04-68.78 (n=57). Participants will be quasi-randomized to one of three groups: control (normal activities), low-tempo Zumba®, and high-tempo Zumba®. The quasi-randomization enables the investigators to ensure similarities in relevant demographic factors (e.g., disability type, age, sex) across the three groups. This design will enable the investigators to determine the effects of Zumba® and the impact of exercise tempo. Participants will compete testing three times - pre-test, post-test, and 4-week follow-up test - to determine the immediate and long-term benefits of Zumba®. Changes in functional mobility (Timed Up-And-Go), balance (Clinical Test of Sensory Interaction on Balance), aerobic capacity (6-minute Walk Test), and executive function (Flanker) will be assessed. During the program, participants' MVPA will be measured using wrist-worn accelerometers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

The two different tempo groups will participate in the program using separate HIPPA-compliant Zoom sessions in different rooms at the community programs. The high-tempo group will be called Group 1 and the low-tempo group will be called Group 2.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be healthy enough to participate in exercise (based on the Physical Activity Readiness Questionnaire or a physician's letter)
  • 18 years or older
  • have a diagnosed Developmental disability (e.g., Autism Spectrum Disorder, Down Syndrome, Intellectual Disability, etc.).

排除标准

  • Did not participate in 50% or more of the sessions.

结局指标

主要结局

Change in Cardiorespiratory functioning using the 6-minute Walk Test (6MWT)

时间窗: Pre-test 1 week prior to intervention, Post-test 1 week after the intervention, Follow-up 4 weeks after the intervention (for the Zumba groups only)

The 6MWT is a submaximal exercise test to assess cardiorespiratory functioning. The test includes measures of pre-and post-walk blood pressure, heart rate, blood oxygen levels, and fatigue (Borg Scale). The test consists of walking back and forth between two cones set up at a distance of 15-meters for 6 minutes continuously. The total distance walked in meters is recorded for a single trial. This test is valid for individuals ages 16-80, shows good test-retest reliability (ICC = 0.95), and has been used with adults with DD ages 20-80.

Change in Functional Mobility using the Timed-Up and Go (TUG).

时间窗: Pre-test 1 week prior to intervention, Post-test 1 week after the intervention, Follow-up 4 weeks after the post-test (for the Zumba groups only)

TUG is a measure of functional mobility. The test consists of the participant sitting in a chair (with no arms), rising from the chair, walking 3 meters to a cone, turning around, walking back to the chair, and sitting in the chair. The total time to complete each trial is recorded. Participants complete a total of three trials - one practice trial and two formal trials that are averaged. This test is valid for individuals ages 16-70, shows good test-retest reliability (ICC = 0.92), and has been used with adults with DD ages 20-80.

Change in Static Balance using the Biodex Balance SD - modified Clinical Test of Sensory Interaction on Balance.

时间窗: Pre-test 1 week prior to intervention, Post-test 1 week after the intervention, Follow-up 4 weeks after the post test (for the Zumba groups only)

The Biodex Balance SD measures the center of pressure while the participant stands on the platform during balance tasks. For the purpose of the present proposal, the modified Clinical Test of Sensory Interaction on Balance will be used. This test has been used with adults with developmental disabilities. For this test, the participant stands barefoot with the feet hip-distance apart. Postural sway is measured during each of four conditions (20 seconds per condition): eyes open standing on a firm surface, eyes closed standing on a firm surface, eyes open standing on a foam surface, and eyes closed standing on a foam surface. A sway score is computed based on the sway amplitude.

Change in Attention/Inhibition using the NIH Toolbox Flanker Test.

时间窗: Pre-test 1 week prior to intervention, Post-test 1 week after the intervention, Follow-up 4 weeks after the post-test (for the Zumba groups only)

The Flanker test is a measure of selective attention and inhibition. It is conducted on an iPad. For each trial, the direction of a central arrow will change such that the central arrow will be either congruent or incongruent with flanking arrows (e.g., \< \< \> \< \< or \< \< \< \< \<). The participant will select the direction of the central arrow by touching the corresponding left or right arrow on the iPad below the stimuli. The participant completes 6 practice trials and a total of 20 formal trials. The raw score is converted to an uncorrected standard score (mean = 100, sd = 15). The NIH Toolbox Flanker Test has been normed based on a sample of typically developing children and adults ages 3-85 and has been used with adults with developmental disabilities . The test shows good test-retest reliability (ICC = 0.80).

Change in Physical activity levels

时间窗: Throughout all 20 intervention days.

Wrist-worn triaxial accelerometer (ActiGraph GT3X, Pensacola, Florida) will be used to measure physical activity levels (i.e., light, moderate, vigorous, very vigorous physical activity) during each adapted Zumba® session. The wear time validation algorithm is Choi, which automatically classifies "non-wear time" for 90 minutes of consecutive zero/nonzero counts. The Freedson cut-points will be used for scoring PA into the following categories: light (0-2689 counts per 60 second), moderate (2690-6166 counts per 60 second), vigorous (6167-9642 counts per 60 second), and very vigorous (\>9643 counts per 60 second). The wear time validation and cut-points have been used to evaluate PA in adults with disabilities ages 23-72.

次要结局

  • Change in Body mass index(Pre-test 1 week prior to intervention, Post-test 1 week after the intervention, Follow-up 4 weeks after the post-test (for the Zumba groups only))
  • Change in Weight(Pre-test 1 week prior to intervention, Post-test 1 week after the intervention, Follow-up 4 weeks after the post-test (for the Zumba groups only))
  • Change in Body fat percentage(Pre-test 1 week prior to intervention, Post-test 1 week after the intervention, Follow-up 4 weeks after the post-test (for the Zumba groups only))
  • Change in Body Fat Mass(Pre-test 1 week prior to intervention, Post-test 1 week after the intervention, Follow-up 4 weeks after the post-test (for the Zumba groups only))
  • Change in Fat free mass(Pre-test 1 week prior to intervention, Post-test 1 week after the intervention, Follow-up 4 weeks after the post-test (for the Zumba groups only))
  • Change in Height(Pre-test 1 week prior to intervention, Post-test 1 week after the intervention, Follow-up 4 weeks after the post-test (for the Zumba groups only))

研究者

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

Melissa Pangelinan

Associate Professor

Auburn University

研究点 (2)

Loading locations...

相似试验