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Research on disease early warning and intervention of poor mental and physical health status in the elderly

Research on mental and physical health assessment system and service model for the elderly based on TCM physical identification and multimodal technology (subtopic 3): Research on disease early warning and intervention of poor mental and physical health status in the elderly

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041801
Enrollment
Unknown
Registered
2021-01-05
Start date
2021-02-28
Completion date
Unknown
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subthreshold depression, mild cognitive impairment

Interventions

Mild cognitive impairment experimental group:Dietary guidance, gongfa guidance
Mild cognitive impairment control group:Nil
Subthreshold depression experimental group:Dietary guidance, gongfa guidance
Subthreshold depression control group:Nil

Sponsors

Xuanwu Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnostic criteria and basis 1. Diagnostic criteria of depression under threshold In this study, the commonly accepted diagnostic criteria of depression under threshold were used (1) The patients with depressive symptoms did not meet the diagnostic criteria of depression, that is, they did not meet the "major depressive episode" symptom index (with more than 5 of the 9 indexes) and course index (lasting for at least 2 weeks) of DSM-V, accompanied by occupational dysfunction and social dysfunction; (2) The total score of CES-D was more than 16; (3) Hamilton 17 item Depression Scale score: 7 <= HAMD total score < 17; (4) At the same time, those who met the criteria of (1), (2) and (3) were diagnosed as subthreshold depressive disorder. 2. Diagnostic criteria of mild cognitive impairment According to the diagnostic criteria of MCI (refer to Peterson criteria) (1) The onset was insidious; (2) Memory impairment was the main complaint; (3) There was objective evidence of memory loss (the degree of memory loss was lower than 1.5 standard deviations of the age and education matched controls); (4) It may be accompanied by other cognitive impairment, but memory loss is more prominent; (5) The overall cognitive function was normal; (6) Activities of daily living (ADL) < 23; (7) It did not meet the diagnostic criteria of dementia; (8) Imaging support diagnosis. Inclusion Criteria 1. The inclusion criteria of depression under the threshold (1) It was in accordance with the diagnostic criteria of Western medicine; (2) Age 60-80 years old, male or female, right handedness; (3) Hamilton 17 item Depression Scale score: 7 <= HAMD total score < 17; (4) The subjects and their guardians voluntarily participated in the clinical trial, signed the informed consent, and had good compliance with the research protocol. Only those who meet the above four items can be selected. 2. Inclusion criteria of mild cognitive impairment (1) According to the diagnostic criteria of MCI; (2) Age 60-80 years old, male or female, right handedness; (3) The score of Montreal Cognitive Assessment (MoCA) was less than 25 for those with less than 12 years of education, and 26 for those with more than 12 years of education; (4) The subjects and their guardians voluntarily participated in the clinical trial, signed the informed consent, and had good compliance with the research protocol. Only those who meet the above four items can be selected.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. The exclusion criteria of depression under the threshold (1) Patients with depression, previous mental illness and organic mental disorder were diagnosed; (2) Patients participating in other clinical trials; (3) Severe aphasia, agnosia and inability to communicate; (4) Patients with unstable vital signs; (5) Patients with infectious diseases, malignant tumor, severe infection and serious primary diseases in circulatory, respiratory, endocrine, digestive and hematopoietic systems; (6) Patients with metal implants, implantable electronic devices and cochlear implants in their heads; (7) Patients with intracranial organic lesions, infection, craniocerebral trauma and operation history; (8) Patients with serious alcohol and drug abuse. Those meeting one of the above criteria will be excluded. 2. Exclusion criteria of mild cognitive impairment (1) Patients with history of epilepsy, family history or recent use of tricyclic antidepressants, neuroblockers and other drugs to reduce seizure threshold (high frequency rTMS has the risk of inducing epilepsy); (2) Patients who use other drugs to improve cognitive function and participate in other clinical trials; (3) Severe aphasia, agnosia and inability to communicate; (4) Patients with unstable vital signs; (5) Patients with infectious diseases, malignant tumor, severe infection and serious primary diseases in circulatory, respiratory, endocrine, digestive and hematopoietic systems; (6) Patients with metal implants, implantable electronic devices and cochlear implants in their heads; (7) Patients with intracranial organic lesions, infection, craniocerebral trauma and operation history; (8) Patients with serious alcohol and drug abuse. Those meeting one of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
TCM Constitution Scale;HAMD;HAMA;MoCA;Multimodal Bioinformatics;Inflammatory factors;Metabolic marker;Oral and intestinal flora;Diffusion Tensor imaging (DTI);Brain Functional Imaging (fMRI);

Secondary

MeasureTime frame
Blood routine;Biochemical routine;Routine urine;

Countries

China

Contacts

Public ContactQu Miao

Xuanwu Hospital of Capital Medical University

qumiaotcm@126.com+86 13621104599

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026