Clinical trial NCT05610917: Community-based Rehabilitation Management for Patients With Remitted Geriatric Depression
Official title: Construction and Evaluation of Risk Early Warning Mechanism of Physical Cognitive Decline Syndrome and Community-based Rehabilitation Management Program for Patients With Remitted Geriatric Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Geriatric Depression
Keywords: Remitted geriatric depression
Physio-cognitive decline syndrome
risk early warning mechanism
community-based rehabilitation management
Lead sponsor: Chengde Medical University
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study intends to take patients with RGD as objects. Further construct a community-based rehabilitation management (CBRM) program with drug treatment, rehabilitation measures of education, psychology and exercise as its core content on the basis of evidence-based practice approach. Based on the cost-utility analysis of health economics, the health and economic benefits of the CBRM program will be evaluated, and a theoretical reference will be provided for community health institutions to carry out whole-course rehabilitation management practice and health policy formulation.

Detailed description: Based on the background of population aging, the prevalence of Late life depression tends to increase, and the recurrence rate after antidepressants treatment is still as high as 35%-57%, and the disease course tends to be chronic. Therefore, the formulation and implementation of prevention and control programs have become a significant part of the government's work plan. Physical frailty symptoms such as loss of daily activities and weakness are common in patients with remitted geriatric depression (RGD), and cognitive impairment is also considered to be an independent persistent symptom of RGD patients, which are related to the fluctuation and recurrence of depressive symptoms in elderly patients. Physical cognitive decline syndrome (PCDS) can comprehensively assess the physical frailty symptoms and the degree of cognitive impairment of the elderly, and effectively predict the course of the disease and the trend of healthy development. However, studies applied to the field of emotional disorder have not been retrieved. Therefore, this study intends to take patients with RGD as objects to investigate the prevalence of PCDS, build a risk prediction model and reveal it is warning mechanisms. That is, after determinning the basis of risk factors affecting the occurence of PCDS in RGD patients, we will carry out the formulation, implementation and evaluation of the follow-up CBRM program.

Eligibility criteria: Inclusion Criteria:

* aged 60 years old or above at the time of enrollment;
* 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:

* meet the diagnostic of schizophrenia, bipolar disorder, dementia;
* 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.

Primary outcomes:
measure: depressive symptoms
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: cognitive and intellectual function
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: changes of the handgrip strength
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: changes of the gait speed
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
Secondary outcomes:
measure: quality of life of the elderly
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: sleep quality
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: the balance ability of the elderly
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: activity of daily living
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: the word memory function
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: language functions
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: verbal functions
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: visuospatial structure ability and visual memory of the elderly
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: working memory portion of the executive function
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
measure: the executive ability and the visuospatial ability
timeFrame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
Other outcomes:
Locations:
city: Chengde
country: China
facility: Chengde Medical University
state: Hebei
Study officials:
affiliation: Chengde Medical University
name: Li Duan, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.