Clinical trial NCT05198232: The Effects of Virtual Zumba® in Individuals With Developmental Disabilities
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Disability
Autism Spectrum Disorder
Down Syndrome
Cerebral Palsy
Keywords: Adaptive Exercise
Virtual Exercise
Executive Functioning
Dance
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be quasi-randomized to one of three groups: control (normal activities), low-tempo Zumba®, and high-tempo Zumba®. This quasi-randomization enables the groups to be matched on relevant demographics (disability type, age, sex). This design will enable the investigators to determine the effects of Zumba® and the impact of exercise tempo.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cardiorespiratory functioning using the 6-minute Walk Test (6MWT)
timeFrame: 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)
measure: Change in Functional Mobility using the Timed-Up and Go (TUG).
timeFrame: 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)
measure: Change in Static Balance using the Biodex Balance SD - modified Clinical Test of Sensory Interaction on Balance.
timeFrame: 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)
measure: Change in Attention/Inhibition using the NIH Toolbox Flanker Test.
timeFrame: 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)
measure: Change in Physical activity levels
timeFrame: Throughout all 20 intervention days.
Secondary outcomes:
measure: Change in Body mass index
timeFrame: 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)
measure: Change in Weight
timeFrame: 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)
measure: Change in Body fat percentage
timeFrame: 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)
measure: Change in Body Fat Mass
timeFrame: 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)
measure: Change in Fat free mass
timeFrame: 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)
measure: Change in Height
timeFrame: 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)
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University School of Kinesiology
state: Alabama
Study officials:
affiliation: Auburn University
name: Emily Munn
role: STUDY_DIRECTOR
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