Mild Cognitive ImpairmentLD-MCINCT07058844
The Effects of a Line Dance Program on Cognitive Function, Physical Function, and Quality of Life in Older Adults With Mild Cognitive Impairment
A study testing High-BPM Line Dance, Low-BPM Line Dance and Usual Daily Activity in people with Mild Cognitive Impairment, run by Wanyu Shu at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- High-BPM Line Dance, Low-BPM Line Dance and Usual Daily Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2025to 16 May 2025
- 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 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently taking antidepressants, antipsychotics, or sedative-hypnotic medications
- Pregnant or potentially breastfeeding
- Currently participating in another drug-related clinical trial
- Diagnosed with dementia
Trial locations and contacts
1 site in 1 country.
China1 site
Nankang District Hospital of Traditional Chinese Medicine
Ganzhou, Jiangxi, 341000
About this study
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- High-BPM Line Dance, Low-BPM Line Dance, Usual Daily Activity
- Keywords
- Mild Cognitive Impairment, Line Dance, Aerobic Exercise, Cognitive Function, BDNF, Dual Task, Older Adults, Quality of Life, Randomized Controlled Trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-BPM Line DanceBehavioural
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.
Low-BPM Line DanceBehavioural
Also called LBLD
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.
Usual Daily ActivityOther
No structured intervention will be provided. Participants will continue their routine lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| High-BPM Line Dance Group | Experimental | 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. Receives: Behavioral: High-BPM Line Dance |
| Low-BPM Line Dance Group | Experimental | 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. Receives: Behavioral: Low-BPM Line Dance |
| Control Group | Other | Participants in this group will not receive any specific intervention but will maintain their usual daily activities throughout the 12-week period. Receives: Other: Usual Daily Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA
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.
Measured: Baseline and 12 weeks post-intervention
SMS（Sensorimotor Synchronization）
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)
Measured: Baseline and after 12-week intervention
BDNF (Brain-Derived Neurotrophic Factor)
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.
Measured: Baseline and after 12-week intervention
TUG-cog(Timed Up and Go-Cognitive)
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.
Measured: Baseline and after 12-week intervention
Senior Fitness Test
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.
Measured: Baseline and 12 weeks post-intervention
Short Physical Performance Battery
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.
Measured: Baseline and 12 weeks post-intervention
Grip Strength
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.
Measured: Baseline and 12 weeks post-intervention
Short Form-36 Health Survey
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.
Measured: Baseline and 12 weeks post-intervention
Secondary outcomes (4)
Depression
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.
Measured: Baseline and 12 weeks post-intervention
Blood glucose
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.
Measured: Baseline and 12 weeks post-intervention
Berg Balance Scale (BBS)
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.
Measured: Baseline and after 12-week intervention
Blood pressure
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.
Measured: Baseline and after 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start19 Jan 2025
- Primary completion19 Apr 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: a high-BPM line dance intervention group, a low-BPM line dance intervention group, or a no-intervention control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wanyu Shu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wanyu Shu, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058844
- Sponsor's protocol ID
- HYU-MCI-2025-01
- Other IDs
- HYUIRB-202503-002-1
- Acronym
- LD-MCI
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Line Dance Program on Cognitive Function, Physical Function, and Quality of Life in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07058844
- Acronym / sponsor ID
- LD-MCI / HYU-MCI-2025-01
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Line Dance, Aerobic Exercise, Cognitive Function, BDNF, Dual Task, Older Adults, Quality of Life, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Wanyu ShuUniversity, hospital or other
- Study start
- 19 Jan 2025 (actual)
- Primary completion
- 19 Apr 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 10 Jul 2025 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: a high-BPM line dance intervention group, a low-BPM line dance intervention group, or a no-intervention control group.
| Arm | Type | Receives |
|---|---|---|
| High-BPM Line Dance Group | Experimental | Behavioral: High-BPM Line DanceParticipants 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. |
| Low-BPM Line Dance Group | Experimental | Behavioral: Low-BPM Line DanceParticipants 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. |
| Control Group | Other | Other: Usual Daily ActivityParticipants in this group will not receive any specific intervention but will maintain their usual daily activities throughout the 12-week period. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Currently taking antidepressants, antipsychotics, or sedative-hypnotic medications
- Pregnant or potentially breastfeeding
- Currently participating in another drug-related clinical trial
- Diagnosed with dementia
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 |
|---|---|---|
| High-BPM Line DanceA 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. | Behavioural | High-BPM Line Dance Group |
| Low-BPM Line DanceAlso: LBLDA structured aerobic dance program set to music with tempos of 90-100 BPM, using the same choreography but slower rhythm and reduced rest intervals. | Behavioural | Low-BPM Line Dance Group |
| Usual Daily ActivityNo structured intervention will be provided. Participants will continue their routine lifestyle. | Other | Control Group |
Primary outcome
MoCA
Time frame: Baseline and 12 weeks post-intervention
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.
SMS（Sensorimotor Synchronization）
Time frame: Baseline and after 12-week intervention
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)
BDNF (Brain-Derived Neurotrophic Factor)
Time frame: Baseline and after 12-week intervention
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.
TUG-cog(Timed Up and Go-Cognitive)
Time frame: Baseline and after 12-week intervention
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.
Senior Fitness Test
Time frame: Baseline and 12 weeks post-intervention
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.
Short Physical Performance Battery
Time frame: Baseline and 12 weeks post-intervention
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.
Grip Strength
Time frame: Baseline and 12 weeks post-intervention
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.
Short Form-36 Health Survey
Time frame: Baseline and 12 weeks post-intervention
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.
4 secondary outcomes
Depression
Time frame: Baseline and 12 weeks post-intervention
Blood glucose
Time frame: Baseline and 12 weeks post-intervention
Berg Balance Scale (BBS)
Time frame: Baseline and after 12-week intervention
Blood pressure
Time frame: Baseline and after 12-week intervention
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 10 Jul 2025.
- Individual participant dataSharing planned: No. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-BPM Line Dance, Low-BPM Line Dance and Usual Daily Activity in people with Mild Cognitive Impairment, run by Wanyu Shu at 1 site in China.
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: finished, as of the sponsor's last update on 10 Jul 2025. 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 China. 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?
MoCA (time frame: Baseline and 12 weeks post-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2025; AzTrials last refreshed its copy on 27 Oct 2026.