Developmental DisabilityNCT05198232
The Effects of Virtual Zumba® in Individuals With Developmental Disabilities
A study testing Zumba High Tempo and Zumba Low Tempo in people with Developmental Disability and Autism Spectrum Disorder, run by Auburn University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Developmental Disability, Autism Spectrum Disorder, Down Syndrome
- What is being tested?
- Zumba High Tempo and Zumba Low Tempo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- Did not participate in 50% or more of the sessions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Auburn University School of Kinesiology
Auburn, Alabama, 36849
About this study
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
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.
Read the 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:
- 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).
- 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).
- 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).
- 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.
- Being tested
- Zumba High Tempo, Zumba Low Tempo
- Keywords
- Adaptive Exercise, Virtual Exercise, Executive Functioning, Dance
- Medical subject headings
- Developmental Disabilities, Autism Spectrum Disorder, Down Syndrome, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zumba High TempoBehavioural
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 TempoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Zumba Low Tempo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Throughout all 20 intervention days.
Secondary outcomes (6)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start26 Jan 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Pangelinan, Auburn University
- Investigators
- Emily Munn, Study director, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198232
- Sponsor's protocol ID
- Virtual Adaptive Zumba
- Status last verified
- May 2022
- First submitted
- 11 Nov 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymous participant data will be available through a request to the principal investigator.
Publications
Blaskowitz, M., Scott, P., Randall, L., Zelenko, M., Green, M., McGrady, E…, Lonergan, M. (2020) Closing the gap: Identifying self-reported quality of life differences between youth with and without intellectual and developmental disabilities. Inclusion, 8 (3), 241-254.
Blomqvist S, Wester A, Sundelin G, Rehn B. Test-retest reliability, smallest real difference and concurrent validity of six different balance tests on young people with mild to moderate intellectual disability. Physiotherapy. 2012 Dec;98(4):313-9. doi: 10.1016/j.physio.2011.05.006. Epub 2011 Sep 13.
PubMed 23122437Bouzas S, Martinez-Lemos RI, Ayan C. Effects of exercise on the physical fitness level of adults with intellectual disability: a systematic review. Disabil Rehabil. 2019 Dec;41(26):3118-3140. doi: 10.1080/09638288.2018.1491646. Epub 2018 Oct 9.
PubMed 30301367Carmeli E, Bachar A, Merrick J. Blood parameters in adults with intellectual disability at rest and after endurance exercise. Res Sports Med. 2009;17(2):95-103. doi: 10.1080/15438620902900260.
PubMed 19479628Choi L, Liu Z, Matthews CE, Buchowski MS. Validation of accelerometer wear and nonwear time classification algorithm. Med Sci Sports Exerc. 2011 Feb;43(2):357-64. doi: 10.1249/MSS.0b013e3181ed61a3.
PubMed 20581716Cleaver S, Hunter D, Ouellette-Kuntz H. Physical mobility limitations in adults with intellectual disabilities: a systematic review. J Intellect Disabil Res. 2009 Feb;53(2):93-105. doi: 10.1111/j.1365-2788.2008.01137.x. Epub 2008 Dec 2.
PubMed 19067784Cluphf, D., O'Connor, J., & Vanin, S. (2001). Effects of aerobic dance on the cardiovascular endurance of adults with intellectual disabilities. Adapted Physical Activity Quarterly, 18(1).
Coppus AM. People with intellectual disability: what do we know about adulthood and life expectancy? Dev Disabil Res Rev. 2013;18(1):6-16. doi: 10.1002/ddrr.1123.
PubMed 23949824de Winter CF, Hermans H, Evenhuis HM, Echteld MA. Associations of symptoms of anxiety and depression with diabetes and cardiovascular risk factors in older people with intellectual disability. J Intellect Disabil Res. 2015 Feb;59(2):176-85. doi: 10.1111/jir.12049. Epub 2013 Apr 30.
PubMed 23627768Enkelaar L, Smulders E, van Schrojenstein Lantman-de Valk H, Weerdesteyn V, Geurts AC. Clinical measures are feasible and sensitive to assess balance and gait capacities in older persons with mild to moderate Intellectual Disabilities. Res Dev Disabil. 2013 Jan;34(1):276-85. doi: 10.1016/j.ridd.2012.08.014. Epub 2012 Sep 15.
PubMed 22985782Freedson PS, Lyden K, Kozey-Keadle S, Staudenmayer J. Evaluation of artificial neural network algorithms for predicting METs and activity type from accelerometer data: validation on an independent sample. J Appl Physiol (1985). 2011 Dec;111(6):1804-12. doi: 10.1152/japplphysiol.00309.2011. Epub 2011 Sep 1.
PubMed 21885802Frey GC, Stanish HI, Temple VA. Physical activity of youth with intellectual disability: review and research agenda. Adapt Phys Activ Q. 2008 Apr;25(2):95-117. doi: 10.1123/apaq.25.2.95.
PubMed 18493087Guerra-Balic M, Oviedo GR, Javierre C, Fortuno J, Barnet-Lopez S, Nino O, Alamo J, Fernhall B. Reliability and validity of the 6-min walk test in adults and seniors with intellectual disabilities. Res Dev Disabil. 2015 Dec;47:144-53. doi: 10.1016/j.ridd.2015.09.011. Epub 2015 Sep 29.
PubMed 26426514Heller T, Sorensen A. Promoting healthy aging in adults with developmental disabilities. Dev Disabil Res Rev. 2013;18(1):22-30. doi: 10.1002/ddrr.1125.
PubMed 23949826Hilapo, P. E., Olea, C. V. B., Panara-ag, A. B., Felismino, N. A., Valera, A. J., & Jr, R. R. V. (2006). Developing speed, flexibility and endurance of people with developmental disabilities using Zumba. Journal of Sciences, Technology and Arts Research, 2, 47-51.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05198232
- Acronym / sponsor ID
- Virtual Adaptive Zumba
- Keywords
- Adaptive Exercise, Virtual Exercise, Executive Functioning, Dance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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).
- 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).
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Zumba High TempoThe 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 | Experimental | Behavioral: Zumba Low TempoThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.).
Key exclusion criteria (1 listed)
- Did not participate in 50% or more of the sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zumba High TempoThe 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. | Behavioural | Zumba High Tempo |
| Zumba Low TempoThe 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. | Behavioural | Zumba Low Tempo |
Primary outcome
Change in Cardiorespiratory functioning using the 6-minute Walk Test (6MWT)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
6 secondary outcomes
Change in Body mass index
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- BackgroundBlaskowitz, M., Scott, P., Randall, L., Zelenko, M., Green, M., McGrady, E…, Lonergan, M. (2020) Closing the gap: Identifying self-reported quality of life differences between youth with and without intellectual and developmental disabilities. Inclusion, 8 (3), 241-254.
- Background: PubMed 23122437Blomqvist S, Wester A, Sundelin G, Rehn B. Test-retest reliability, smallest real difference and concurrent validity of six different balance tests on young people with mild to moderate intellectual disability. Physiotherapy. 2012 Dec;98(4):313-9. doi: 10.1016/j.physio.2011.05.006. Epub 2011 Sep 13.
- Background: PubMed 30301367Bouzas S, Martinez-Lemos RI, Ayan C. Effects of exercise on the physical fitness level of adults with intellectual disability: a systematic review. Disabil Rehabil. 2019 Dec;41(26):3118-3140. doi: 10.1080/09638288.2018.1491646. Epub 2018 Oct 9.
- Background: PubMed 19479628Carmeli E, Bachar A, Merrick J. Blood parameters in adults with intellectual disability at rest and after endurance exercise. Res Sports Med. 2009;17(2):95-103. doi: 10.1080/15438620902900260.
- Background: PubMed 20581716Choi L, Liu Z, Matthews CE, Buchowski MS. Validation of accelerometer wear and nonwear time classification algorithm. Med Sci Sports Exerc. 2011 Feb;43(2):357-64. doi: 10.1249/MSS.0b013e3181ed61a3.
- Background: PubMed 19067784Cleaver S, Hunter D, Ouellette-Kuntz H. Physical mobility limitations in adults with intellectual disabilities: a systematic review. J Intellect Disabil Res. 2009 Feb;53(2):93-105. doi: 10.1111/j.1365-2788.2008.01137.x. Epub 2008 Dec 2.
- BackgroundCluphf, D., O'Connor, J., & Vanin, S. (2001). Effects of aerobic dance on the cardiovascular endurance of adults with intellectual disabilities. Adapted Physical Activity Quarterly, 18(1).
- Background: PubMed 23949824Coppus AM. People with intellectual disability: what do we know about adulthood and life expectancy? Dev Disabil Res Rev. 2013;18(1):6-16. doi: 10.1002/ddrr.1123.
- Background: PubMed 23627768de Winter CF, Hermans H, Evenhuis HM, Echteld MA. Associations of symptoms of anxiety and depression with diabetes and cardiovascular risk factors in older people with intellectual disability. J Intellect Disabil Res. 2015 Feb;59(2):176-85. doi: 10.1111/jir.12049. Epub 2013 Apr 30.
- Background: PubMed 22985782Enkelaar L, Smulders E, van Schrojenstein Lantman-de Valk H, Weerdesteyn V, Geurts AC. Clinical measures are feasible and sensitive to assess balance and gait capacities in older persons with mild to moderate Intellectual Disabilities. Res Dev Disabil. 2013 Jan;34(1):276-85. doi: 10.1016/j.ridd.2012.08.014. Epub 2012 Sep 15.
- Background: PubMed 21885802Freedson PS, Lyden K, Kozey-Keadle S, Staudenmayer J. Evaluation of artificial neural network algorithms for predicting METs and activity type from accelerometer data: validation on an independent sample. J Appl Physiol (1985). 2011 Dec;111(6):1804-12. doi: 10.1152/japplphysiol.00309.2011. Epub 2011 Sep 1.
- Background: PubMed 18493087Frey GC, Stanish HI, Temple VA. Physical activity of youth with intellectual disability: review and research agenda. Adapt Phys Activ Q. 2008 Apr;25(2):95-117. doi: 10.1123/apaq.25.2.95.
- Individual participant dataSharing planned: Yes. Individual anonymous participant data will be available through a request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Munn study director
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zumba High Tempo and Zumba Low Tempo in people with Developmental Disability and Autism Spectrum Disorder, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiorespiratory functioning using the 6-minute Walk Test (6MWT) (time frame: 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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05198232, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.