The Effects of Virtual Zumba® in Individuals With Developmental Disabilities

NCT05198232 | Completed

• 1 other identifier: Virtual Adaptive Zumba
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Disability; Autism Spectrum Disorder; Down Syndrome; Cerebral Palsy

Keywords

Adaptive Exercise; Virtual Exercise; Executive Functioning; Dance

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (6)

• 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)

Study Arms (3)

Control Group

NO INTERVENTION

This group will complete normal daily activities. The participants will complete pre-test, 10 weeks of normal daily activities, and post-test. No changes to their daily schedule will be made by the researcher, the control group will participate in normal activities as part of their community day program.

Zumba High Tempo

EXPERIMENTAL

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.

Behavioral: Zumba High Tempo

Zumba Low Tempo

EXPERIMENTAL

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.

Behavioral: Zumba Low Tempo

Interventions

Zumba High Tempo BEHAVIORAL

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 High Tempo

Zumba Low Tempo BEHAVIORAL

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.

Zumba Low Tempo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University School of Kinesiology

Auburn, Alabama, 36849, United States

Location

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MeSH Terms

Conditions

Developmental Disabilities; Autism Spectrum Disorder; Down Syndrome; Cerebral Palsy

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Emily Munn

  Auburn University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: January 20, 2022
• Study Start: January 26, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: 5 years following publication.
• Access Criteria: Data will be shared with researchers with a minimum qualification of a master's degree in a relevant field (e.g., special education, neuroscience, exercise physiology, kinesiology, disability studies, adapted physical education).

Locations

US (1)