Mild Cognitive ImpairmentNCT04788238
Dual-Task Zumba Gold for Improving the Cognition of Older Adults With MCI
A study testing Dual-Task Zumba Gold in people with Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Philippines.
Trial summary
The study aims to assess the preliminary efficacy of a Dual-Task Zumba Gold (DTZ) intervention that will support physical and cognitive training among community-dwelling persons with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Dual-Task Zumba Gold
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePhilippines
- Study dates
- 29 Mar 2021to 31 Aug 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjective report/concern about changes in memory or cognition
- objective cognitive impairment, based on Montreal Cognitive Assessment (MoCA) score of ≤25
- absence of diagnosis of dementia or Alzheimer's disease
- normal function in daily activities, via Katz ADL scale score of 6
- ambulatory, without the need to use assistive devices
- able to read/communicate in the Filipino/English language
Who cannot join
- medical diagnosis of any form of neurological or psychiatric disorder
- uncontrolled or severe heart condition, cancer, major musculoskeletal disorder, psychiatric condition, serious hearing/visual impairment, or any condition that would limit study safety; or being at risk for adverse events to PA participation, assessed via the revised Physical Activity Readiness Questionnaire (rPARQ)
- intake of medications such as anti-depressants, sedatives, or anti-epileptics that may affect cognition
- participation in any organized physical activity program in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual-Task Zumba Gold for Improving the Cognition of Community-Dwelling Older Adults With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial
The study aims to assess the preliminary efficacy of a Dual-Task Zumba Gold (DTZ) intervention that will support physical and cognitive training among community-dwelling persons with mild cognitive impairment (MCI). A 12-week Dual-Task Zumba Gold (DTZ) intervention will be implemented among 30 participants with MCI in the treatment group, while health education will be provided to another 30 subjects allocated in the control group. Changes in global cognitive function, together with the quality of life, mood, functional mobility, and bodily measures, will be re-assessed after the 12-week intervention and a 6-week follow-up period. Quantitative and qualitative methods will also be employed to assess the feasibility and acceptability outcomes of the study.
Read the detailed description
Background: Dementia risk reduction is considered a public health priority. However, there is a paucity of related interventions among low- and middle-income countries (LMICs), such as the Philippines, despite the higher number of dementia cases in these regions. Meanwhile, individuals with mild cognitive impairment (MCI), being at risk for dementia, are important targets for interventions to promote cognitive health.
The enrichment of physical activities with cognitive exercises, known as dual-task training, is an innovative approach that has been noted to potentially improve cognitive outcomes in persons with MCI. Zumba is a popular dance worldwide, which combines rhythmic aerobic steps and whole-body movements. It has a modified version for older adults, called Zumba Gold, but information about its effects on older people is limited.
Literature states that ensuring sufficient cognitive load in complex motor activities is important to achieve significant and superior cognitive outcomes. Dual-Task Zumba Gold (DTZ), an intervention combining Zumba Gold and simultaneous cognitive training, and is a novel and inexpensive non-pharmacological intervention that may enhance the cognition of persons at risk for dementia. However, its feasibility and potential efficacy among older people with MCI are unknown.
Objectives of the Study: There are two objectives in this study: (1) To determine the feasibility and acceptability of a Dual-Task Zumba Gold (DTZ) intervention among community-dwelling individuals with MCI. (2) To investigate the preliminary efficacy of the DTZ intervention in improving the cognitive function among the recruited participants with MCI.
Methods: This is a mixed-method pilot study, involving quantitative and qualitative methods to evaluate the study outcomes. The proposed 12-week DTZ intervention will be conducted three times/week for 45-60 minutes among individuals with MCI. Cognitive domains of executive function, visuospatial ability, memory, and complex attention will be stimulated through mental exercises which will be performed concurrently with the dance steps during particular sequences of the Zumba Gold dance.
Sixty participants will be recruited, and then randomly allocated to treatment (DTZ) and control groups (health education). The feasibility of the intervention will be assessed by participant recruitment and retention rate, adherence rate, and implementation fidelity. Acceptability will be evaluated quantitatively via self-report attitudes towards the intervention. Moreover, qualitative data will be collected via focus group discussions to obtain their feedback toward the intervention.
Changes in cognitive function will be assessed as the primary outcomes, to be measured via the following tools: Montreal Cognitive Assessment (MoCA-P) for global cognition; Trail Making Tests A and B (TMT A \& B) for executive functioning; Digit Span Test (DST) and MoCA-Memory Index Score (MoCA-MIS) for memory. Secondary outcomes to be evaluated include quality of life (Perceived Well-being Scale), mood (Geriatric Depression Scale-Short Form), functional mobility (Short Physical Performance Battery), and bodily measures (blood pressure, body mass index, and waist circumference).
Content analysis will be utilized to analyze qualitative data from the interviews. Meanwhile, descriptive statistics, Chi-square test, and independent t-test will be used to analyze the subjects' characteristics and compare the two groups at baseline. Generalized estimating equations (GEE) will be used to determine the intervention's preliminary efficacy at the post-treatment period.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Dual-Task Zumba Gold
- Keywords
- dual-task, Zumba Gold, mild cognitive impairment, dementia risk reduction
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task Zumba GoldBehavioural
Dual-Task Zumba Gold is a 12-week program to be conducted thrice weekly for 45-60 minutes. The intervention involves the concurrent performance of cognitive tasks and physical movements during specific parts of the dance. The activity will begin with warm-up and end with cool-down periods, at 5 to 10 minutes each. Orientation training will be done during the warm-up period, by asking questions to participants about time, place, and person. In the actual dance (30 to 40 minutes), the following domains will be trained: executive function (forward and backward serial counting); perceptual-motor ability (performing arm clock positions based on instructions); memory (forward and backward repetition of number/word series), and attention (forward and backward spelling of 3- to 5-letter words). The cool-down period will incorporate memory training by reminding the participants to summarize the activities performed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention arm will participate in the dual-task Zumba Gold (DTZ) program. They will be grouped into 10 participants per class. Receives: Behavioral: Dual-Task Zumba Gold |
| Control group | No intervention | Participants in the control group will receive health education about dementia risk reduction provided by community health nurses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Montreal Cognitive Assessment score (from baseline to 18 weeks follow-up)
Montreal Cognitive Assessment (MoCA) evaluates global cognition by involving multiple domains such as attention, memory, language, visuospatial skills, abstraction, calculation, and orientation. The scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline; 12 weeks; 18 weeks
Changes in Trail Making Test Part A (from baseline to 18 weeks follow-up)
Trail Making Test Part A is a time-based examination that requires individuals to connect randomly arranged numbers following the correct sequence. The time limit for this test is up to 150 seconds, and shorter duration pertains to better processing speed.
Measured: Baseline; 12 weeks; 18 weeks
Changes in Trail Making Test Part B (from baseline to 18 weeks follow-up)
Trail Making Test Part B is a time-based examination that requires individuals to connect randomly arranged numbers and letters following the correct and alternating sequence. The time limit for this test is up to 300 seconds, and shorter duration pertains to better executive function.
Measured: Baseline; 12 weeks; 18 weeks
Changes in Digit Span test (from baseline to 18 weeks follow-up)
In Digit Span Test, numbers are read to the participant at a rate of one per second and then later asked to repeat them in a forward and backward manner. Scores range from 0 - 14 and higher scores indicate better short-term memory.
Measured: Baseline; 12 weeks; 18 weeks
Changes in the MoCA-Memory Index score (from baseline to 18 weeks follow-up)
The Memory Index Score of the Montreal Cognitive Assessment (MoCA-MIS) ranges from 0-15, which is based on free delayed recall, category cued recall, and multiple choice cued recall. Higher scores indicate better delayed recall ability.
Measured: Baseline; 12 weeks; 18 weeks
Secondary outcomes (6)
Changes in quality of life using Perceived Well-Being Scale (from baseline to 18 weeks follow-up)
The Perceived Well-Being Scale (PWB) assesses older adults' quality of life in the physical and psychological domains, using a 14-item tool with a 7-point Likert scale. Its scores range from 14-98, and higher values pertain to higher quality of life.
Measured: Baseline; 12 weeks; 18 weeks
Changes in mood using Geriatric Depression Scale-Short Form (from baseline to 18 weeks follow-up)
The Geriatric Depression Scale-Short Form (GDS-SF) is a 15-item instrument which is answered dichotomously by 'yes' or 'no' responses. Scores range from 0-15, with lower scores pertaining to better emotional status.
Measured: Baseline; 12 weeks; 18 weeks
Changes in functional mobility using Short Physical Performance Battery (from baseline to 18 weeks follow-up)
The Short Physical Performance Battery (SPPB) measures timed performance on three tasks (standing balance, gait speed, and rising from a chair) to derive a score from 0-12. Higher scores indicate better functional mobility.
Measured: Baseline; 12 weeks; 18 weeks
Changes in blood pressure (from baseline to 18 weeks follow-up)
Blood pressure will reflect systolic and diastolic measures, and will be assessed through calibrated blood pressure monitors.
Measured: Baseline; 12 weeks; 18 weeks
Changes in body-mass index (from baseline to 18 weeks follow-up)
Body mass index will be reported in kg/m^2, by obtaining the participants' weight (in kilograms) and height (in meters) via a Detecto scale.
Measured: Baseline; 12 weeks; 18 weeks
Changes in waist circumference (from baseline to 18 weeks follow-up)
Waist circumference will be measured in centimeters via tape measure.
Measured: Baseline; 12 weeks; 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start29 Mar 2021
- Primary completion15 Oct 2021
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be equally allocated to the intervention and control group, following a randomization schedule generated by an independent statistician who has no access to the subjects. The randomization list will be sealed in sequentially numbered opaque envelopes. Participants will be informed of the group allocation after the submission of written consent and completion of the baseline assessments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Angela Leung, The Hong Kong Polytechnic University
- Investigators
- Angela Leung, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788238
- Sponsor's protocol ID
- HSEARS20200717002
- Status last verified
- Jan 2022
- First submitted
- 25 Feb 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbott JH. The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. J Orthop Sports Phys Ther. 2014 Aug;44(8):555-8. doi: 10.2519/jospt.2014.0110. No abstract available.
PubMed 25082389American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
PubMed 19516148Barcelos N, Shah N, Cohen K, Hogan MJ, Mulkerrin E, Arciero PJ, Cohen BD, Kramer AF, Anderson-Hanley C. Aerobic and Cognitive Exercise (ACE) Pilot Study for Older Adults: Executive Function Improves with Cognitive Challenge While Exergaming. J Int Neuropsychol Soc. 2015 Nov;21(10):768-79. doi: 10.1017/S1355617715001083.
PubMed 26581789Cardinal BJ, Esters J, Cardinal MK. Evaluation of the revised physical activity readiness questionnaire in older adults. Med Sci Sports Exerc. 1996 Apr;28(4):468-72. doi: 10.1097/00005768-199604000-00011.
PubMed 8778552Dalleck LC, Roos KA, Byrd BR, Weatherwax RM. Zumba Gold((R)): Are The Physiological Responses Sufficient to Improve Fitness in Middle-Age to Older Adults? J Sports Sci Med. 2015 Aug 11;14(3):689-90. eCollection 2015 Sep. No abstract available.
PubMed 26336358Diamond A, Ling DS. Conclusions about interventions, programs, and approaches for improving executive functions that appear justified and those that, despite much hype, do not. Dev Cogn Neurosci. 2016 Apr;18:34-48. doi: 10.1016/j.dcn.2015.11.005. Epub 2015 Dec 7.
PubMed 26749076Dominguez JC, Orquiza MG, Soriano JR, Magpantay CD, Esteban RC, Corrales ML, Ampil ER. Adaptation of the Montreal Cognitive Assessment for elderly Filipino patients. East Asian Arch Psychiatry. 2013 Sep;23(3):80-5.
PubMed 24088400Gheysen F, Poppe L, DeSmet A, Swinnen S, Cardon G, De Bourdeaudhuij I, Chastin S, Fias W. Physical activity to improve cognition in older adults: can physical activity programs enriched with cognitive challenges enhance the effects? A systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2018 Jul 4;15(1):63. doi: 10.1186/s12966-018-0697-x.
PubMed 29973193Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
PubMed 8126356Katz S. Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living. J Am Geriatr Soc. 1983 Dec;31(12):721-7. doi: 10.1111/j.1532-5415.1983.tb03391.x.
PubMed 6418786Kayama H, Okamoto K, Nishiguchi S, Yamada M, Kuroda T, Aoyama T. Effect of a Kinect-based exercise game on improving executive cognitive performance in community-dwelling elderly: case control study. J Med Internet Res. 2014 Feb 24;16(2):e61. doi: 10.2196/jmir.3108.
PubMed 24565806Lauenroth A, Ioannidis AE, Teichmann B. Influence of combined physical and cognitive training on cognition: a systematic review. BMC Geriatr. 2016 Jul 18;16:141. doi: 10.1186/s12877-016-0315-1.
PubMed 27431673Luettgen M, Foster C, Doberstein S, Mikat R, Porcari J. Zumba((R)): is the "fitness-party" a good workout? J Sports Sci Med. 2012 Jun 1;11(2):357-8. eCollection 2012. No abstract available.
PubMed 24137072McIsaac TL, Lamberg EM, Muratori LM. Building a framework for a dual task taxonomy. Biomed Res Int. 2015;2015:591475. doi: 10.1155/2015/591475. Epub 2015 Apr 19.
PubMed 25961027Moreau D, Morrison AB, Conway AR. An ecological approach to cognitive enhancement: complex motor training. Acta Psychol (Amst). 2015 May;157:44-55. doi: 10.1016/j.actpsy.2015.02.007. Epub 2015 Feb 25.
PubMed 25725192
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Task Zumba Gold for Improving the Cognition of Community-Dwelling Older Adults With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04788238
- Acronym / sponsor ID
- HSEARS20200717002
- Conditions
- Mild Cognitive Impairment
- Keywords
- dual-task, Zumba Gold, mild cognitive impairment, dementia risk reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 9 Mar 2021 (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.
The study aims to assess the preliminary efficacy of a Dual-Task Zumba Gold (DTZ) intervention that will support physical and cognitive training among community-dwelling persons with mild cognitive impairment (MCI). A 12-week Dual-Task Zumba Gold (DTZ) intervention will be implemented among 30 participants with MCI in the treatment group, while health education will be provided to another 30 subjects allocated in the control group. Changes in global cognitive function, together with the quality of life, mood, functional mobility, and bodily measures, will be re-assessed after the 12-week intervention and a 6-week follow-up period. Quantitative and qualitative methods will also be employed to assess the feasibility and acceptability outcomes of the study.
Detailed description
Background: Dementia risk reduction is considered a public health priority. However, there is a paucity of related interventions among low- and middle-income countries (LMICs), such as the Philippines, despite the higher number of dementia cases in these regions. Meanwhile, individuals with mild cognitive impairment (MCI), being at risk for dementia, are important targets for interventions to promote cognitive health.
The enrichment of physical activities with cognitive exercises, known as dual-task training, is an innovative approach that has been noted to potentially improve cognitive outcomes in persons with MCI. Zumba is a popular dance worldwide, which combines rhythmic aerobic steps and whole-body movements. It has a modified version for older adults, called Zumba Gold, but information about its effects on older people is limited.
Literature states that ensuring sufficient cognitive load in complex motor activities is important to achieve significant and superior cognitive outcomes. Dual-Task Zumba Gold (DTZ), an intervention combining Zumba Gold and simultaneous cognitive training, and is a novel and inexpensive non-pharmacological intervention that may enhance the cognition of persons at risk for dementia. However, its feasibility and potential efficacy among older people with MCI are unknown.
Objectives of the Study: There are two objectives in this study: (1) To determine the feasibility and acceptability of a Dual-Task Zumba Gold (DTZ) intervention among community-dwelling individuals with MCI. (2) To investigate the preliminary efficacy of the DTZ intervention in improving the cognitive function among the recruited participants with MCI.
Methods: This is a mixed-method pilot study, involving quantitative and qualitative methods to evaluate the study outcomes. The proposed 12-week DTZ intervention will be conducted three times/week for 45-60 minutes among individuals with MCI. Cognitive domains of executive function, visuospatial ability, memory, and complex attention will be stimulated through mental exercises which will be performed concurrently with the dance steps during particular sequences of the Zumba Gold dance.
Sixty participants will be recruited, and then randomly allocated to treatment (DTZ) and control groups (health education). The feasibility of the intervention will be assessed by participant recruitment and retention rate, adherence rate, and implementation fidelity. Acceptability will be evaluated quantitatively via self-report attitudes towards the intervention. Moreover, qualitative data will be collected via focus group discussions to obtain their feedback toward the intervention.
Changes in cognitive function will be assessed as the primary outcomes, to be measured via the following tools: Montreal Cognitive Assessment (MoCA-P) for global cognition; Trail Making Tests A and B (TMT A \& B) for executive functioning; Digit Span Test (DST) and MoCA-Memory Index Score (MoCA-MIS) for memory. Secondary outcomes to be evaluated include quality of life (Perceived Well-being Scale), mood (Geriatric Depression Scale-Short Form), functional mobility (Short Physical Performance Battery), and bodily measures (blood pressure, body mass index, and waist circumference).
Content analysis will be utilized to analyze qualitative data from the interviews. Meanwhile, descriptive statistics, Chi-square test, and independent t-test will be used to analyze the subjects' characteristics and compare the two groups at baseline. Generalized estimating equations (GEE) will be used to determine the intervention's preliminary efficacy at the post-treatment period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be equally allocated to the intervention and control group, following a randomization schedule generated by an independent statistician who has no access to the subjects. The randomization list will be sealed in sequentially numbered opaque envelopes. Participants will be informed of the group allocation after the submission of written consent and completion of the baseline assessments.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Dual-Task Zumba GoldParticipants in the intervention arm will participate in the dual-task Zumba Gold (DTZ) program. They will be grouped into 10 participants per class. |
| Control group | No intervention | –Participants in the control group will receive health education about dementia risk reduction provided by community health nurses. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- subjective report/concern about changes in memory or cognition
- objective cognitive impairment, based on Montreal Cognitive Assessment (MoCA) score of ≤25
- absence of diagnosis of dementia or Alzheimer's disease
- normal function in daily activities, via Katz ADL scale score of 6
- ambulatory, without the need to use assistive devices
Key exclusion criteria (4 listed)
- medical diagnosis of any form of neurological or psychiatric disorder
- uncontrolled or severe heart condition, cancer, major musculoskeletal disorder, psychiatric condition, serious hearing/visual impairment, or any condition that would limit study safety; or being at risk for adverse events to PA participation, assessed via the revised Physical Activity Readiness Questionnaire (rPARQ)
- intake of medications such as anti-depressants, sedatives, or anti-epileptics that may affect cognition
- participation in any organized physical activity program in the past 3 months
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 |
|---|---|---|
| Dual-Task Zumba GoldDual-Task Zumba Gold is a 12-week program to be conducted thrice weekly for 45-60 minutes. The intervention involves the concurrent performance of cognitive tasks and physical movements during specific parts of the dance. The activity will begin with warm-up and end with cool-down periods, at 5 to 10 minutes each. Orientation training will be done during the warm-up period, by asking questions to participants about time, place, and person. In the actual dance (30 to 40 minutes), the following domains will be trained: executive function (forward and backward serial counting); perceptual-motor ability (performing arm clock positions based on instructions); memory (forward and backward repetition of number/word series), and attention (forward and backward spelling of 3- to 5-letter words). The cool-down period will incorporate memory training by reminding the participants to summarize the activities performed. | Behavioural | Intervention group |
Primary outcome
Changes in Montreal Cognitive Assessment score (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
Montreal Cognitive Assessment (MoCA) evaluates global cognition by involving multiple domains such as attention, memory, language, visuospatial skills, abstraction, calculation, and orientation. The scores range from 0 to 30, with higher scores indicating better cognitive performance.
Changes in Trail Making Test Part A (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
Trail Making Test Part A is a time-based examination that requires individuals to connect randomly arranged numbers following the correct sequence. The time limit for this test is up to 150 seconds, and shorter duration pertains to better processing speed.
Changes in Trail Making Test Part B (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
Trail Making Test Part B is a time-based examination that requires individuals to connect randomly arranged numbers and letters following the correct and alternating sequence. The time limit for this test is up to 300 seconds, and shorter duration pertains to better executive function.
Changes in Digit Span test (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
In Digit Span Test, numbers are read to the participant at a rate of one per second and then later asked to repeat them in a forward and backward manner. Scores range from 0 - 14 and higher scores indicate better short-term memory.
Changes in the MoCA-Memory Index score (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
The Memory Index Score of the Montreal Cognitive Assessment (MoCA-MIS) ranges from 0-15, which is based on free delayed recall, category cued recall, and multiple choice cued recall. Higher scores indicate better delayed recall ability.
6 secondary outcomes
Changes in quality of life using Perceived Well-Being Scale (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
Changes in mood using Geriatric Depression Scale-Short Form (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
Changes in functional mobility using Short Physical Performance Battery (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
Changes in blood pressure (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
Changes in body-mass index (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
Changes in waist circumference (from baseline to 18 weeks follow-up)
Time frame: Baseline; 12 weeks; 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Background: PubMed 25082389Abbott JH. The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. J Orthop Sports Phys Ther. 2014 Aug;44(8):555-8. doi: 10.2519/jospt.2014.0110. No abstract available.
- Background: PubMed 19516148American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
- Background: PubMed 26581789Barcelos N, Shah N, Cohen K, Hogan MJ, Mulkerrin E, Arciero PJ, Cohen BD, Kramer AF, Anderson-Hanley C. Aerobic and Cognitive Exercise (ACE) Pilot Study for Older Adults: Executive Function Improves with Cognitive Challenge While Exergaming. J Int Neuropsychol Soc. 2015 Nov;21(10):768-79. doi: 10.1017/S1355617715001083.
- Background: PubMed 8778552Cardinal BJ, Esters J, Cardinal MK. Evaluation of the revised physical activity readiness questionnaire in older adults. Med Sci Sports Exerc. 1996 Apr;28(4):468-72. doi: 10.1097/00005768-199604000-00011.
- Background: PubMed 26336358Dalleck LC, Roos KA, Byrd BR, Weatherwax RM. Zumba Gold((R)): Are The Physiological Responses Sufficient to Improve Fitness in Middle-Age to Older Adults? J Sports Sci Med. 2015 Aug 11;14(3):689-90. eCollection 2015 Sep. No abstract available.
- Background: PubMed 26749076Diamond A, Ling DS. Conclusions about interventions, programs, and approaches for improving executive functions that appear justified and those that, despite much hype, do not. Dev Cogn Neurosci. 2016 Apr;18:34-48. doi: 10.1016/j.dcn.2015.11.005. Epub 2015 Dec 7.
- Background: PubMed 24088400Dominguez JC, Orquiza MG, Soriano JR, Magpantay CD, Esteban RC, Corrales ML, Ampil ER. Adaptation of the Montreal Cognitive Assessment for elderly Filipino patients. East Asian Arch Psychiatry. 2013 Sep;23(3):80-5.
- Background: PubMed 29973193Gheysen F, Poppe L, DeSmet A, Swinnen S, Cardon G, De Bourdeaudhuij I, Chastin S, Fias W. Physical activity to improve cognition in older adults: can physical activity programs enriched with cognitive challenges enhance the effects? A systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2018 Jul 4;15(1):63. doi: 10.1186/s12966-018-0697-x.
- Background: PubMed 8126356Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
- Background: PubMed 6418786Katz S. Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living. J Am Geriatr Soc. 1983 Dec;31(12):721-7. doi: 10.1111/j.1532-5415.1983.tb03391.x.
- Background: PubMed 24565806Kayama H, Okamoto K, Nishiguchi S, Yamada M, Kuroda T, Aoyama T. Effect of a Kinect-based exercise game on improving executive cognitive performance in community-dwelling elderly: case control study. J Med Internet Res. 2014 Feb 24;16(2):e61. doi: 10.2196/jmir.3108.
- Background: PubMed 27431673Lauenroth A, Ioannidis AE, Teichmann B. Influence of combined physical and cognitive training on cognition: a systematic review. BMC Geriatr. 2016 Jul 18;16:141. doi: 10.1186/s12877-016-0315-1.
- Individual participant dataSharing planned: No
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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.
Angela Leung, PhD principal investigator
The Hong Kong Polytechnic 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 Dual-Task Zumba Gold in people with Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Philippines.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Feb 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 Philippines. 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?
Results are not available in the source record.
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?
Changes in Montreal Cognitive Assessment score (from baseline to 18 weeks follow-up) (time frame: Baseline; 12 weeks; 18 weeks). 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 NCT04788238, which also lists 23 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 4 Feb 2022.