Skip to main content
Clinical Trials/NCT05310890
NCT05310890
Not yet recruiting
Not Applicable

Long Term Prospective Study of Tai Chi Intervention to Prevent MCI From Conversion to Dementia

Ruijin Hospital0 sites206 target enrollmentSeptember 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Ruijin Hospital
Enrollment
206
Primary Endpoint
Incidence of MCI converted to Alzheimer's disease.
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

This study evaluates the effects of 3 years-Tai Chi exercise intervention on cognitive function in MCI patients and to clarify whether the intervention can prevent MCI from conversion to dementia. Patients will be randomized into the Tai chi training group and the control group.

Detailed Description

Dementia is a syndrome of impairments of cortical functions caused by brain diseases. More than 55 million people worldwide are currently living with dementia, with nearly 10 million new cases each year. Alzheimer's disease is the most common form of dementia and may account for 60-70% of patients with dementia. Mild cognitive impairment (MCI) is an intermediate state between normal cognitive aging and dementia. About 10% to 15% of patients with MCI progress to dementia each year. Therefore, it is crucial to find intervention strategies to prevent the progression of MCI to dementia. However, drug interventions are currently ineffective in the prevention of dementia. Based on the synaptic plasticity, more and more studies focus on non-drug interventions. Our research group previously found 6-months non-drug interventions (cognitive training, exercise therapy) can effectively delay cognitive decline in the elderly, providing a new strategy for the improvement of cognition in the elderly. Therefore, this project plans to conduct a multi-site, randomized, parallel-controlled clinical trial to examine the effect of 3 years-Tai Chi exercise intervention on cognitive function in MCI patients and to clarify whether the intervention can prevent MCI from conversion to dementia.

Registry
clinicaltrials.gov
Start Date
September 2022
End Date
September 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shengdi Chen

Professor

Ruijin Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of MCI converted to Alzheimer's disease.

Time Frame: 36 months

The 3-year incidence of AD in each group will be compared.

The global cognitive function of MCI patients.

Time Frame: 18 months and 36 months

11-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog 11) will be used to assess the global cognitive performance of MCI patients. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.

Secondary Outcomes

  • Memory(18 months and 36 months)
  • Attention(18 months and 36 months)
  • Executive function(18 months and 36 months)
  • Language(18 months and 36 months)
  • Working memory test(18 months and 36 months)
  • Visual spatial ability(18 months and 36 months)
  • Change from baseline in MMSE score(18 months and 36 months)
  • Change from baseline in MoCA score(18 months and 36 months)
  • Change from baseline in CDR score(18 months and 36 months)
  • Activities of daily living(18 months and 36 months)
  • Anxiety(18 months and 36 months)
  • Depression(18 months and 36 months)
  • Sleep(18 months and 36 months)
  • Brain activity(36 months)
  • Neurodegeneration in brain structures(36 months)
  • Gut microbiota(18 months and 36 months)
  • Blood biomarkers(18 months and 36 months)

Similar Trials