NCT07658469

Brief Summary

The aging of China's rural population is severe, with both the prevalence and mortality rates of dementia higher in rural areas than in urban areas. Motor Cognitive Risk Syndrome (MCR), as a novel pre-dementia syndrome characterized by both subjective cognitive decline and slow gait, represents a "golden window of opportunity" for the early prevention and treatment of dementia. Currently, there is no specific pharmacological treatment for MCR; non-pharmacological interventions, particularly exercise interventions, are key strategies. Moderate-intensity aerobic calisthenics, which integrates music, dance, and gymnastic elements, is economical, simple, highly engaging, safe, and has demonstrated potential for improving both cognitive and gait function, making it especially suitable for promotion in resource-limited rural settings. However, there is a lack of systematic, theory-guided exercise intervention protocols and effectiveness validation for rural older adults with MCR. Therefore, this study aims to develop and validate a moderate-intensity aerobic calisthenics intervention protocol tailored to this population.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress15%
Jul 2026Jan 2027

First Submitted

Initial submission to the registry

June 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 14, 2026

Last Update Submit

June 14, 2026

Conditions

Keywords

MCRMotoric Cognitive Risk Syndromemoderate-intensity aerobic exerciserural areasAged

Outcome Measures

Primary Outcomes (2)

  • Montreal Cognitive Assessment Basic

    The MoCA-B was jointly developed by the Montreal Cognitive Assessment Clinic and Research Institute in Canada, in collaboration with the Prince Mahidol Award Foundation of Thailand and the Faculty of Medicine at Chulalongkorn University. It has a total score of 30 points and encompasses eight cognitive domains: executive function, language, orientation, calculation, abstract thinking, memory, visual perception, and attention, with higher scores indicating better cognitive function. The cutoff values are as follows: for years of education ≤6 years, MoCA-B ≥20; for 6 years \< years of education ≤12 years, MoCA-B ≥23; and for years of education \>12 years, MoCA-B ≥25. The scale correctly identifies cognitively normal participants with a specificity of 86%, and demonstrates a sensitivity of 81% for detecting cognitive impairment. The Cronbach's α coefficient of the scale is 0.807, and the criterion valid

    The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.

  • Walking speed

    The timed walking test was used to measure gait speed. The required equipment included a tape measure and a stopwatch. The specific procedure was as follows: First, a straight 6-meter course was measured using the tape measure, and the middle 4-meter segment was marked. The participant stood at the starting point. Then, upon the tester's command "Start," the participant walked at their normal pace to the endpoint. The time taken to cover the middle 4 meters was recorded using the same stopwatch. This was performed twice. Finally, gait speed was calculated using the formula speed = distance / time, with the average time of the two trials used for calculation.

    The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.

Secondary Outcomes (9)

  • Subjective Cognitive Decline-questionnaire 9

    The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.

  • short physical performance battery

    The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.

  • Handgrip strength

    The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.

  • Body fat

    The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.

  • 12-Item Short-Form Health Survey

    The intervention was carried out in August 2026, and the assessment period was 0,3,6 months.

  • +4 more secondary outcomes

Study Arms (2)

Moderate-intensity aerobic exercise

EXPERIMENTAL

The group was intervened with a moderate-intensity aerobic exercise program developed by the research team.

Other: moderate-intensity aerobic exercise

Routine Care

EXPERIMENTAL

This group of elderly people maintained their daily routines and received health education.

Other: Routine Care

Interventions

Based on routine health education, the intervention group receives a 12-week moderate-intensity aerobic exercise intervention (Jiamusi Happy Dance Steps) lasting 60 minutes per session, three times per week, delivered in a group setting, followed by a 12-week follow-up period.

Moderate-intensity aerobic exercise

While maintaining daily living habits unchanged, provide knowledge related to health education for Motor Cognitive Risk Syndrome (MCR) and receive the MCR health education manual.

Routine Care

Eligibility Criteria

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

You may qualify if:

  • Age ≥60 years;
  • Meeting the diagnostic criteria for Motor Cognitive Risk Syndrome (MCR);
  • Clear consciousness and ability to communicate clearly;
  • Permanent residents of rural areas in nine prefecture-level cities of Fujian Province (with an annual residence of ≥9 months) and no plan to relocate within the next year; -⑤ Willing to voluntarily participate and sign the informed consent form.

You may not qualify if:

  • Presence of severe mental disorders, history of stroke, Parkinson's disease, or severe visual/auditory impairments;
  • Physical disability that prevents independent walking;
  • Comorbid severe systemic diseases, such as cardiopulmonary conditions; -④ Regular exercise habits within the past 6 months (≥30 minutes/day, ≥3 days/week) or a long-term history of exercise; -⑤ Current participation in other interventional studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University

Fuzhou, Fujian, 350100, China

Location

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 22, 2026

Study Start

July 1, 2026

Primary Completion

July 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations