- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07058844
- Original Trial
The Effects of a Line Dance Program on Cognitive Function, Physical Function, and Quality of Life in Older Adults With Mild Cognitive Impairment (LD-MCI)
July 1, 2025 updated by: Wanyu Shu
This study aims to evaluate the effects of a structured line dance program on cognitive function, physical performance, and quality of life in older women with mild cognitive impairment (MCI).
A total of 75 participants aged 60-75 with a diagnosis of MCI will be randomly assigned to one of three groups: a high-beat-per-minute (HBLD) line dance group, a low-beat-per-minute (LBLD) line dance group, or a control group receiving no intervention.
The intervention will last for 12 weeks, with sessions held three times per week for 60 minutes.
Outcome measures include the Montreal Cognitive Assessment (MoCA), serum brain-derived neurotrophic factor (BDNF), physical function tests, and a quality of life questionnaire.
The purpose of this study is to explore the effectiveness of non-pharmacological, rhythm-based exercise interventions for improving cognitive and physical health in older adults with cognitive decline.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiangxi
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Ganzhou, Jiangxi, China, 341000
- Nankang District Hospital of Traditional Chinese Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Female participants aged between 60 and 75 years who have been clinically diagnosed with mild cognitive impairment (MCI) at a medical institution (MoCA score ≤ 25)
- No history of psychiatric disorders
- Not currently taking any psychiatric medications
- Normal vision and hearing, and able to complete the assessments without difficulty
- Physically capable of participating in line dance sessions
- Provided written informed consent and voluntarily agreed to participate in the study
Exclusion Criteria:
- Currently taking antidepressants, antipsychotics, or sedative-hypnotic medications
- Pregnant or potentially breastfeeding
- Currently participating in another drug-related clinical trial
- Diagnosed with dementia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-BPM Line Dance Group
Participants in this group will engage in a line dance intervention with music tempos of 130-140 beats per minute (BPM), three times per week for 12 weeks.
Each session lasts 60 minutes and includes warm-up, core choreography, and cool-down phases.
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A structured aerobic dance program set to music with tempos of 130-140 BPM, designed to improve cognitive and physical function in older adults with MCI.
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Experimental: Low-BPM Line Dance Group
Participants in this group will engage in a line dance intervention with music tempos of 90-100 beats per minute (BPM), three times per week for 12 weeks.
Each session lasts 60 minutes and follows the same structure as the HBLD group.
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A structured aerobic dance program set to music with tempos of 90-100 BPM, using the same choreography but slower rhythm and reduced rest intervals.
Other Names:
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Other: Control Group
Participants in this group will not receive any specific intervention but will maintain their usual daily activities throughout the 12-week period.
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No structured intervention will be provided.
Participants will continue their routine lifestyle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MoCA
Time Frame: Baseline and 12 weeks post-intervention
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Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated screening tool for detecting mild cognitive impairment.
Scores range from 0 to 30, with higher scores indicating better cognitive performance.
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Baseline and 12 weeks post-intervention
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SMS(Sensorimotor Synchronization)
Time Frame: Baseline and after 12-week intervention
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This study used ELAN software (version 6.9) to analyze temporal asynchrony between participants' dance movements and rhythmic cues across four 8-beat sequences (32 beats total).
Movement and rhythm layers were time-annotated to assess synchronization accuracy and stability.
Data were exported to Excel for analysis.
Mean asynchrony indicated synchronization accuracy (higher values = poorer accuracy), while standard deviation reflected synchronization stability (higher values = greater variability)
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Baseline and after 12-week intervention
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BDNF (Brain-Derived Neurotrophic Factor)
Time Frame: Baseline and after 12-week intervention
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Serum levels of Brain-Derived Neurotrophic Factor (BDNF) will be measured to assess neuroplasticity-related changes induced by the intervention.
Blood samples will be collected, processed, and analyzed using enzyme-linked immunosorbent assay (ELISA).
Higher BDNF concentrations are associated with improved synaptic function and cognitive performance.
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Baseline and after 12-week intervention
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TUG-cog(Timed Up and Go-Cognitive)
Time Frame: Baseline and after 12-week intervention
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The TUG-cog test will be used to assess dual-task mobility and executive function.
Participants are asked to complete the standard Timed Up and Go task while simultaneously performing a cognitive task, such as serial subtraction.
The time taken to complete the task is recorded.
Longer completion times reflect greater dual-task interference and reduced cognitive-motor integration.
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Baseline and after 12-week intervention
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Senior Fitness Test
Time Frame: Baseline and 12 weeks post-intervention
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The Senior Fitness Test (SFT) evaluates physical fitness in older adults across six domains: lower-body strength (30-second chair stand), upper-body strength (30-second arm curl), lower-body flexibility (chair sit-and-reach), upper-body flexibility (back scratch), agility and dynamic balance (8-foot up-and-go), and aerobic endurance (2-minute step test).
Higher performance indicates better functional fitness and physical independence.
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Baseline and 12 weeks post-intervention
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Short Physical Performance Battery
Time Frame: Baseline and 12 weeks post-intervention
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The Short Physical Performance Battery (SPPB) is a standardized assessment tool used to evaluate lower-extremity physical function in older adults.
It consists of three components: balance tests (side-by-side, semi-tandem, and tandem stance), a 4-meter walk test to assess gait speed, and five repeated chair stands to evaluate lower-body strength.
The total score ranges from 0 to 12, with higher scores indicating better physical performance and mobility.
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Baseline and 12 weeks post-intervention
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Grip Strength
Time Frame: Baseline and 12 weeks post-intervention
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Grip strength will be measured using a digital hand dynamometer (Model EH101, ANTA, Guangdong, China).
Participants will stand upright with their arms naturally extended at an angle of approximately 15°-30° from the trunk and will squeeze the device with maximum force for a few seconds.
Each hand will be tested twice, and the highest value from either hand will be used for analysis.
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Baseline and 12 weeks post-intervention
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Short Form-36 Health Survey
Time Frame: Baseline and 12 weeks post-intervention
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The SF-36 Health Survey is a widely used instrument for evaluating health-related quality of life.
It consists of 36 items assessing eight domains: physical functioning, role limitations due to physical and emotional problems, bodily pain, general health, vitality, social functioning, and mental health.
Higher scores indicate better perceived health status.
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Baseline and 12 weeks post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: Baseline and 12 weeks post-intervention
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Depressive symptoms will be assessed using the Geriatric Depression Scale (GDS-15), a validated screening tool for older adults.
The scale consists of 15 yes/no questions, with higher scores indicating more severe depressive symptoms.
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Baseline and 12 weeks post-intervention
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Blood glucose
Time Frame: Baseline and 12 weeks post-intervention
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asting blood glucose levels will be measured using standard venous blood sampling procedures.
The values will be expressed in milligrams per deciliter (mg/dL).
Elevated blood glucose levels may indicate impaired glucose metabolism or risk of diabetes.
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Baseline and 12 weeks post-intervention
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Berg Balance Scale (BBS)
Time Frame: Baseline and after 12-week intervention
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The Berg Balance Scale (BBS) is a 14-item performance-based measure that assesses static and dynamic balance abilities in older adults.
Each item is scored on a 5-point scale ranging from 0 to 4, with a maximum total score of 56.
Higher scores indicate better balance ability and lower risk of falling.
The BBS is widely used in clinical and research settings to evaluate postural control and balance improvements following intervention.
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Baseline and after 12-week intervention
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Blood pressure
Time Frame: Baseline and after 12-week intervention
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Blood pressure will be measured using a calibrated electronic sphygmomanometer.
Systolic and diastolic blood pressure will be recorded in a seated position after at least 5 minutes of rest.
Measurements will be taken twice, and the average will be used for analysis.
Blood pressure is an important indicator of cardiovascular health and may be affected by exercise interventions.
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Baseline and after 12-week intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2025
Primary Completion (Actual)
April 19, 2025
Study Completion (Actual)
May 16, 2025
Study Registration Dates
First Submitted
July 1, 2025
First Submitted That Met QC Criteria
July 1, 2025
First Posted (Actual)
July 10, 2025
Study Record Updates
Last Update Posted (Actual)
July 10, 2025
Last Update Submitted That Met QC Criteria
July 1, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYU-MCI-2025-01
- HYUIRB-202503-002-1 (Other Identifier: Hanyang University Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to the sensitive nature of the participant data and the absence of a secured public data-sharing infrastructure, the individual participant data will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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