NCT07058844

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 1, 2025

Last Update Submit

July 1, 2025

Conditions

Keywords

Mild Cognitive Impairment, Line Dance, Aerobic Exercise, Cognitive Function, BDNF, Dual Task, Older Adults, Quality of Life, Randomized Controlled Trial

Outcome Measures

Primary Outcomes (8)

  • 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.

    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)

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline and 12 weeks post-intervention

Secondary Outcomes (4)

  • Depression

    Baseline and 12 weeks post-intervention

  • Blood glucose

    Baseline and 12 weeks post-intervention

  • Berg Balance Scale (BBS)

    Baseline and after 12-week intervention

  • Blood pressure

    Baseline and after 12-week intervention

Study Arms (3)

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.

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.

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.

Other: Usual Daily Activity

Interventions

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.

High-BPM Line Dance Group

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.

Also known as: LBLD
Low-BPM Line Dance Group

No structured intervention will be provided. Participants will continue their routine lifestyle.

Control Group

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales aged 60 to 75 years are eligible to participate.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Currently taking antidepressants, antipsychotics, or sedative-hypnotic medications
  • Pregnant or potentially breastfeeding
  • Currently participating in another drug-related clinical trial
  • Diagnosed with dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nankang District Hospital of Traditional Chinese Medicine

Ganzhou, Jiangxi, 341000, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor of Philosophy

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 10, 2025

Study Start

January 19, 2025

Primary Completion

April 19, 2025

Study Completion

May 16, 2025

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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.

Locations