The Effects of Virtual Zumba® in Individuals With Developmental Disabilities

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05198232
• Other study ID #: Virtual Adaptive Zumba
• Status: Completed
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: May 2022
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. It is hypothesized that: 1. Compared to controls, both adapted Zumba groups will show an increase in balance, functional mobility, and aerobic capacity (Group x Time Interaction). Follow-up t-tests will reveal a dose-dependent improvement in these outcomes between pre-test and post-test (HT>LT>Controls). Moreover, follow-up t-tests will reveal that the high-tempo group will maintain their improvements 4 weeks after the program (post-test to follow-up), compared to the low-tempo group and control group (HT>LT=Controls). 2. Compared to controls, both adapted Zumba groups will show an increase in EF. Follow-up t-tests will reveal a dose-dependent improvement in EF from pre-test to post-test (HT>LT>Controls). Moreover, follow-up t-tests will reveal that the high-tempo group will maintain their improvements 4 weeks after the program (post-test to follow-up), compared to the low-tempo group and control group (HT>LT=Controls). 3. Compared to controls, both adapted Zumba programs will exhibit greater MVPA levels during the program (Group main effect). A follow-up t-test will reveal a dose-dependent increase in MVPA (HT>LT>Controls). 4. Compared to controls, both adapted Zumba programs will exhibit improvements in body composition (Group x Time interaction). Follow-up t-test will reveal that the high-tempo group will exhibit more improvement compared to the low-tempo group and controls (HT >LT>Controls). Methods Participants 57 individuals with DD ages 18-60 years will be recruited from three community day programs for adults with DD. Participants will be included if the participants are healthy enough to participate in exercise (based on the Physical Activity Readiness Questionnaire or a physician's letter), 18 years or older, and have a diagnosed DD (e.g., Autism Spectrum Disorder, Down Syndrome, Intellectual Disability, etc.). Study Design The study will examine the impact of a 10-week (2x a week; 60 minutes per session) virtual adapted aerobic dance intervention (adapted Zumba®) with three groups - control (normal activities), low-tempo Zumba®, and high-tempo Zumba®. This quasi-randomized approach will enable the investigators to match the three groups on relevant demographics (i.e., level of function, age, and diagnosis). This design will enable the investigators to determine the overall effects of Zumba® and the impact of tempo level on outcomes. Participants will compete testing three times - pre-test, post-test, and 4-week post-test - to determine dose-dependent (i.e., tempo) the immediate and long-term benefits of Zumba®. The adapted Zumba® programs will be administered for 10-week (2x a week; 60 minutes per session) via HIPPA-compliant Zoom. Two certified Zumba® instructors will lead the sessions. Both instructors have experience working with children and adults with DD. The instructors will swap halfway through the program to reduce potential instructor bias in leading the high/low tempo sessions. Each session will consist of: a warm-up (3-5 minutes), 4-5 songs with instruction (40 minutes), and a cool down (5 minutes) for a total of about 60 minutes including rest/water breaks and time to transition. The only difference between the two adapted Zumba® programs will be the tempo at which the songs will be played and the number of times through each song. The songs for the low-tempo group will be set to 3/4-speed. The songs for the high-tempo group will be played at full speed; the songs in the high-tempo group will be repeated to ensure an equal amount of time moving for both groups. All sessions will be video recorded and examined for fidelity. The control group will participate in normal activities as part of their community day program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.).

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Cerebral Palsy
• Developmental Disabilities
• Developmental Disability
• Down Syndrome

Intervention

Behavioral:
• Zumba High Tempo
The Zumba high tempo group will complete a 10-week (2x a week; 60 minutes per session) virtual adapted aerobic dance intervention (adapted Zumba®). Each session will consist of: a warm-up (3-5 minutes), 5-6 songs with instruction (40 minutes), and a cool down (5 minutes) for a total of about 60 minutes including rest/water breaks and time to transition. The only difference between the two adapted Zumba® programs will be the speed at which the songs will be played and the number of times through each song. The songs for the high-tempo group will be played at full speed; the songs in the high-tempo group will be repeated to ensure an equal amount of time moving for both groups. All sessions will be video recorded and examined for fidelity. This group will complete pre-test, post-test, and a 4-week follow-up.
• Zumba Low Tempo
The Zumba low tempo group will complete a 10-week (2x a week; 60 minutes per session) virtual adapted aerobic dance intervention (adapted Zumba®). Each session will consist of: a warm-up (3-5 minutes), 5-6 songs with instruction (40 minutes), and a cool down (5 minutes) for a total of about 60 minutes including rest/water breaks and time to transition. The only difference between the two adapted Zumba® programs will be the speed at which the songs will be played and the number of times through each song. The songs for the low-tempo group will be set to three-fourths speed. All sessions will be video recorded and examined for fidelity. This group will complete pre-test, post-test, and a 4-week follow-up.

Locations

Country	Name	City	State
United States	Auburn University School of Kinesiology	Auburn	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cardiorespiratory functioning using the 6-minute Walk Test (6MWT)	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.	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)
Primary	Change in Functional Mobility using the Timed-Up and Go (TUG).	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.	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)
Primary	Change in Static Balance using the Biodex Balance SD - modified Clinical Test of Sensory Interaction on Balance.	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.	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)
Primary	Change in Attention/Inhibition using the NIH Toolbox Flanker Test.	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).	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)
Primary	Change in Physical activity levels	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.	Throughout all 20 intervention days.
Secondary	Change in Body mass index	Body mass index will be measured using a bioelectrical impedance scale (BIA; DC 430-U, Tanita Corporation. Tokyo, Japan). Participants will step onto the scale barefoot and must be still for about 10 seconds.	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)
Secondary	Change in Weight	Weight will be measured using a bioelectrical impedance scale (BIA; DC 430-U, Tanita Corporation. Tokyo, Japan). Participants will step onto the scale barefoot and must be still for about 10 seconds.	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)
Secondary	Change in Body fat percentage	Body fat percentage will be measured using a bioelectrical impedance scale (BIA; DC 430-U, Tanita Corporation. Tokyo, Japan). Participants will step onto the scale barefoot and must be still for about 10 seconds.	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)
Secondary	Change in Body Fat Mass	Body fat mass will be measured using a bioelectrical impedance scale (BIA; DC 430-U, Tanita Corporation. Tokyo, Japan). Participants will step onto the scale barefoot and must be still for about 10 seconds.	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)
Secondary	Change in Fat free mass	Fat free mass will be measured using a bioelectrical impedance scale (BIA; DC 430-U, Tanita Corporation. Tokyo, Japan). Participants will step onto the scale barefoot and must be still for about 10 seconds.	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)
Secondary	Change in Height	Height will be measured using a stadiometer. Participants will step onto the stadiometer barefoot and must be still for about 10 seconds as researchers indicate their 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)