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
Verified date | May 2022 |
Source | Auburn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Auburn University School of Kinesiology | Auburn | Alabama |
Lead Sponsor | Collaborator |
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Auburn University |
United States,
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* Note: There are 34 references in all — Click here to view all references
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) |
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