Community-based Rehabilitation Management for Patients With Remitted Geriatric Depression
NCT ID: NCT05610917
Last Updated: 2022-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
120 participants
INTERVENTIONAL
2023-01-01
2026-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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case group,
Patients in case group will be treated with CBRM program
CBRM (community-based rehabilitation management)
The case group patients will undergo drug treatment (Selective Serotonin Reuptake Inhibitors), health education, cognitive-motor dual task training, cognitive-training.
control group
the control group patients will be treated routinely as usual.
TAR(treatment as routine)
Patients in control group will be treated rountinely which includes drug treatment (SSRIs) and traditional health education.
Interventions
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CBRM (community-based rehabilitation management)
The case group patients will undergo drug treatment (Selective Serotonin Reuptake Inhibitors), health education, cognitive-motor dual task training, cognitive-training.
TAR(treatment as routine)
Patients in control group will be treated rountinely which includes drug treatment (SSRIs) and traditional health education.
Eligibility Criteria
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Inclusion Criteria
* meet the diagnostic criteria for MDD without psychotic features according to DSM-5, and depressive symptoms have been improved and remained stable for at least 2 months after treatment with SSRIs;
* the total score of HAMD-17 is less than 7 at the time of enrollment;
* meet the diagnostic criteria for physio-cognitive decline: 1) the total score of ADL and IADL was less than 26; 2)cognitve decline: first, subjects with severe impairment of cognitive function will be excluded (years of education ≥ 6, MMSE scores \<24;years of education \<6 years, MMSE total score \<14). After completing a neuropsychological task, cogintive declined will be confirmed when any aspects of cognitve function is 1.5 standard deviations lower than that of normal elderly; 3) the grip strength is weakened, and the domaint hand grip strength is \< 28kg for males or \<18kg for females; 4)slow step speed, that is, in a space of length \>10 meters, the subjects walks 6 meters from the starting point at a normal and uniform pace, and the pace is \<1m/s.
* comprehension, reading and writing skills to complete the measurements or complete them with assistance of the researchers with obstacles;
* voluntary participation and signed informed consent.
Exclusion Criteria
* comorbidity of physical diseases, such ascardiovascular and cerebrovascular diseases, rheumatoid arthritis, stroke and malignant tumors;
* history of alcohol or drug dependence;
* severe deformity of spine and limbs;
* complete or partial dependence on caregivers for daily life, such as long-term bedridden, wheelchair assisted;
* have received physical therapy or psychological treatment in the past three months;
* currently participating in other clinical research.
60 Years
ALL
Yes
Sponsors
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Duan Li
OTHER
Responsible Party
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Duan Li
Doctor Duan
Principal Investigators
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Li Duan, Dr.
Role: STUDY_DIRECTOR
Chengde Medical University
Locations
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Chengde Medical University
Chengde, Hebei, China
Countries
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Central Contacts
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References
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Chen LK, Arai H. Physio-cognitive decline as the accelerated aging phenotype. Arch Gerontol Geriatr. 2020 May-Jun;88:104051. doi: 10.1016/j.archger.2020.104051. Epub 2020 Apr 4. No abstract available.
Liu LK, Chou KH, Hsu CH, Peng LN, Lee WJ, Chen WT, Lin CP, Chung CP, Wang PN, Chen LK. Cerebellar-limbic neurocircuit is the novel biosignature of physio-cognitive decline syndrome. Aging (Albany NY). 2020 Nov 25;12(24):25319-25336. doi: 10.18632/aging.104135. Epub 2020 Nov 25.
Liang CK, Lee WJ, Hwang AC, Lin CS, Chou MY, Peng LN, Lin MH, Chen LK. Efficacy of Multidomain Intervention Against Physio-cognitive Decline Syndrome: A Cluster-randomized Trial. Arch Gerontol Geriatr. 2021 Jul-Aug;95:104392. doi: 10.1016/j.archger.2021.104392. Epub 2021 Mar 13.
Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
Chen LK, Hwang AC, Lee WJ, Peng LN, Lin MH, Neil DL, Shih SF, Loh CH, Chiou ST; Taiwan Health Promotion Intervention Study for Elders research group. Efficacy of multidomain interventions to improve physical frailty, depression and cognition: data from cluster-randomized controlled trials. J Cachexia Sarcopenia Muscle. 2020 Jun;11(3):650-662. doi: 10.1002/jcsm.12534. Epub 2020 Mar 5.
Merchant RA, Chan YH, Hui RJY, Tsoi CT, Kwek SC, Tan WM, Lim JY, Sandrasageran S, Wong BLL, Chen MZ, Ng SE, Morley JE. Motoric cognitive risk syndrome, physio-cognitive decline syndrome, cognitive frailty and reversibility with dual-task exercise. Exp Gerontol. 2021 Jul 15;150:111362. doi: 10.1016/j.exger.2021.111362. Epub 2021 Apr 19.
Other Identifiers
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ChengdeMU
Identifier Type: -
Identifier Source: org_study_id
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