NCT06236646

Brief Summary

The objective of this study was to determine the effects of Thai dance with twenty-five squares on cerebrovascular and cognitive function in elderly with mild cognitive impairment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

January 24, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

aerobic exerciseelderlymild cognitive impairmentcerebrovascularrespiratory function

Outcome Measures

Primary Outcomes (7)

  • Cerebrovascular reactivity

    Cerebrovascular reactivity is a test that assesses the response of cerebral blood vessels to carbon dioxide. This test analyzes the ability of cerebral blood vessels to contract and expand. Using an ultrasound machine and a probe with a frequency of 5 to 1 MHz, the partial pressure of CO2 is altered, and Cerebral Blood Flow Velocity (CBFV) is measured in the left middle cerebral artery at an examination depth of 30-65 mm. The variables used for analysis include Time-Averaged Peak Velocity (TAPV), Peak Systolic Velocity; PSV, End Diastolic Velocity; EDV, and Cerebral Blood Vessel Resistance (Pulsatility Index; PI).

    Change from baseline Cerebrovascular reactivity at 12 weeks.

  • Intima-Media Thickness (IMT) test

    Intima-Media Thickness (IMT) is a test conducted on the carotid artery on the side of the neck. Using an ultrasound machine (Philips, EPIQ 5G, USA), the thickness of the carotid artery walls was measured 1-2 cm away from the carotid bulb. Participants had their necks tilted 45 degrees. The artery walls were measured and then analyzed for thickness using the QLAB program.

    Change from baseline Intima-Media Thickness (IMT) at 12 weeks.

  • Brachial-ankle pulse wave velocity (baPWV)

    Brachial-ankle pulse wave velocity (baPWV) is utilized to indicate the arterial stiffness. This noninvasive test measure the time difference in blood pumping (brachial-ankle time delay) between the brachial artery and the posterior tibial artery. The length between both measurement points is then measured, and the pulse pressure wave between the upper arm and ankle is calculated (Brachial-ankle pulse wave velocity: baPWV), with the participant lying on their back on a bed. Next, both wrists and the left upper chest are cleaned with alcohol. The researcher then attaches cuffs to both the participants' arms and ankles, and electrodes of the device for measuring electrocardiograms are attached to the wrists. Additionally, cardiac sound waves (PCG) are placed on the left side near the sternum (Sternal notch).

    Change from baseline Brachial-ankle pulse wave velocity (baPWV) at 12 weeks.

  • Brain oxygen saturation levels

    Brain oxygen saturation levels are assessed in the frontal lobe area using an oxygen saturation level meter (Universal Oximetry System), measured in percentage units. The evaluation is performed with a brain oxygen saturation level assessment device, specifically the SenSmart® Model X-100 (SenSmart® Model X-100, USA).

    Change from baseline Brain oxygen saturation levels at 12 weeks.

  • The Monreal Cognitive Assessment (MoCA-T)

    The Monreal Cognitive Assessment, known as MoCA-T, is a questionnaire comprising 11 topics with a maximum score of 30 points. It serves as a comprehensive tool for assessing various aspects of cognitive intelligence in various areas, including management, naming, concentration, language use, and abstract thinking.

    Change from baseline MoCA-T scores at 12 weeks.

  • The Mini-Mental State Examination Thai (MMSE-T)

    The Mini-Mental State Examination Thai (MMSE-T) is a preliminary brain condition test that comprises 11 topics with a maximum score of 30 points. This basic brain state test is utilized to assess various aspects of cognition, including awareness of surrounding conditions, perception of time, spatial orientation, concentration and calculation, language use, and repetition.

    Change from baseline MMSE-T scores at 12 weeks.

  • The Trail Making Test B Thai modified (TMT-B)

    The Trail Making Test B Thai modified (TMT-B) is a subtest in the Halstead-Reitan Neuropsychological test, adapted into Thai. The criteria for normalcy is set at no more than 89 seconds for individuals aged 60 years and over. The test includes numbers 1-13 and month abbreviations in Thai (Jan. - Dec.), totaling 25 characters, which consist of numbers and/or letters. They are arranged in a distributed manner, and when connecting lines are drawn, they will not intersect. The TMT-B serves as an assessment of cognitive ability, focusing on concentration and management.

    Change from baseline TMT-B testing time at 12 weeks.

Secondary Outcomes (13)

  • Pulmonary function (Forced vital capacity; FVC)

    Change from baseline FVC at 12 weeks.

  • Pulmonary function (Forced Expiratory Volume in one second; FEV1)

    Change from baseline FEV1 at 12 weeks.

  • Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)

    Change from baseline FEV1/FVC at 12 weeks.

  • Pulmonary function (Maximal voluntary ventilation; MVV)

    Change from baseline MVV at 12 weeks.

  • Respiratory muscle strength

    Change from baseline respiratory muscle strength at 12 weeks.

  • +8 more secondary outcomes

Study Arms (2)

Thai dance with twenty-five squares (TDT)

EXPERIMENTAL

The participants received a Thai dance with twenty-five squares (TDT) program 3 days/week, 12 weeks. This training comprises 10 minutes of warm up, following by 40 minutes of exercise at 40-50% of heart rate reserve at week 1-4, 50-60% of heart rate reserve at week 5-8, and 60-70% of heart rate reserve at week 9-12, 5 minutes of cool down.

Other: Thai dance with twenty-five squares (TDT)

Control (CON)

SHAM COMPARATOR

The CON group did not have any intervention but usual care.

Other: Control (CON)

Interventions

The participants received a Thai dance with twenty-five squares (TDT) program 3 days/week, 12 weeks. This training comprises 10 minutes of warm up, following by 40 minutes of exercise at 40-50% of heart rate reserve at week 1-4, 50-60% of heart rate reserve at week 5-8, and 60-70% of heart rate reserve at week 9-12, 5 minutes of cool down.

Thai dance with twenty-five squares (TDT)

The CON group did not have any intervention but usual care.

Control (CON)

Eligibility Criteria

Age60 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly males and females aged 60-79 years who can lead normal daily lives. Individuals with mild cognitive impairment identified through the Montreal Cognitive Assessment (MoCA) with a score in the range of 17 - 25.
  • Must be able to listen, speak, read, write, and understand the Thai language.
  • Should not have diseases or abnormalities such as heart disease, eye complications caused by diabetes, uncontrolled high blood pressure, kidney complications caused by diabetes, and stroke.
  • Must not have other respiratory diseases such as tuberculosis (Tuberculosis), asthma (Asthma), lung cancer (Lung cancer), emphysema (Emphysema), chronic obstructive pulmonary disease (COPD), etc.
  • Must be a person not at risk of falling, determined through a test of the ability to walk and turn 3 meters within a time period of 7 - 15 seconds.
  • Must not have received medication to treat dementia.
  • Should not have received exercise training for more than 20 minutes at a time, 3 days/week, or more in the past 6 months before participating in the research.
  • Should not have symptoms of mental disorders such as schizophrenia, bipolar disorder, or depression.
  • Should have passed the pre-exercise readiness assessment (PAR-Q).
  • Must be willing to participate in the research and sign the consent form to take part in the study.

You may not qualify if:

  • A force majeure event, such as illness, that prevents participation in the research.
  • Participation in less than 80% of the research sessions (must participate 29 times out of 36 times).
  • Unwillingness to continue participating in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Wannaporn Tongtako

Bangkok, 10330, Thailand

Location

Related Publications (4)

  • Akazawa N, Tanahashi K, Kosaki K, Ra SG, Matsubara T, Choi Y, Zempo-Miyaki A, Maeda S. Aerobic exercise training enhances cerebrovascular pulsatility response to acute aerobic exercise in older adults. Physiol Rep. 2018 Apr;6(8):e13681. doi: 10.14814/phy2.13681.

  • Bherer L. Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Ann N Y Acad Sci. 2015 Mar;1337:1-6. doi: 10.1111/nyas.12682.

  • Boyle PA, Buchman AS, Wilson RS, Leurgans SE, Bennett DA. Physical frailty is associated with incident mild cognitive impairment in community-based older persons. J Am Geriatr Soc. 2010 Feb;58(2):248-55. doi: 10.1111/j.1532-5415.2009.02671.x. Epub 2010 Jan 8.

  • Miller SM, Taylor-Piliae RE. Effects of Tai Chi on cognitive function in community-dwelling older adults: a review. Geriatr Nurs. 2014 Jan-Feb;35(1):9-19. doi: 10.1016/j.gerinurse.2013.10.013. Epub 2013 Oct 24.

MeSH Terms

Conditions

Cognitive DysfunctionRespiratory Aspiration

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wannaporn Tongtako, Ph.D.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

January 3, 2024

Primary Completion

May 15, 2024

Study Completion

June 1, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations