Geriatric DepressionEarly Phase 1NCT05610917
Community-based Rehabilitation Management for Patients With Remitted Geriatric Depression
A Early Phase 1 study testing CBRM (community-based rehabilitation management) and TAR(treatment as routine) in people with Geriatric Depression, run by Duan Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Depression
- What is being tested?
- CBRM (community-based rehabilitation management) and TAR(treatment as routine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Geriatric Depression
- Being tested
- CBRM (community-based rehabilitation management), TAR(treatment as routine)
- Keywords
- Remitted geriatric depression, Physio-cognitive decline syndrome, risk early warning mechanism, community-based rehabilitation management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBRM (community-based rehabilitation management)Combination product
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)Combination product
Patients in control group will be treated rountinely which includes drug treatment (SSRIs) and traditional health education.
| Study group | Role | What they receive |
|---|---|---|
| case group, | Experimental | Patients in case group will be treated with CBRM program Receives: Combination Product: CBRM (community-based rehabilitation management) |
| control group | Other | the control group patients will be treated routinely as usual. Receives: Combination Product: TAR(treatment as routine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive symptoms
The Hamilton Depressive Scale (HAMD-17) which consists of 17 items will be employed to screen for depressive symptoms and evaluate the mental status and severity of depressive symptoms. Scores were calculated by totaling the responses, which can be divided into four types (Health): normal/not depressed (0-7 points), mild/subthreshold (8-13), moderate/mild (14-18), severe/moderate (19-22), and severe/very severe (>23).
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
cognitive and intellectual function
Mini-mental State Examination (MMSE), as a simple screening tool for cognitive and intellectual function decline in the elderly with a total score of 30. The results of this test is closely related to the level of education, and the normal cutoff is defined as, illiterates >17 points, primary schools >20 points, and middle schools and above >24 points.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
changes of the handgrip strength
The grip strength of a man's dominant hand < 28kg or a woman < 18kg is considered to have weak grip strength. The grip strength increased compared with the baseline period, that is, the subjects' physiological function tended to recover; Instead, physiological function tends to decline.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
changes of the gait speed
The time it takes for the subject to walk 6 meters at normal pace from the starting point without slowing down, with a threshold for gait deceleration set to < 1m/s. The gait speed increased compared with the baseline period, that is, the subjects' physiological function tended to recover; Instead, physiological function tends to decline.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
Secondary outcomes (10)
quality of life of the elderly
The WHO Quality of Life Scale (WHOQOL-BREF Chinese version) includes four dimensions, such as physiological, psychological, social relations and environment, covering 26 items related to quality of life. This scale is widely used in patients with cancer, chronic diseases and the elderly. Each item is scored according to Likert 1-5. The higher the total score, the better the quality of life.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
sleep quality
The Pittsburgh Sleep Quality Index (PSQI) will be used to measure the subjects' sleep treatment. The total score range is 0-21 points. It is generally believed that the total score of PSQI ≤7 indicates that the sleep quality is fair, while the total score of > 7 indicates poor sleep quality, and the higher the total score of PSQI scale, the worse the sleep quality of the subjects.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
the balance ability of the elderly
The Short Physical Performance Battery test (SPPB) will be used to assess the balance ability of the elderly, including: (1) Sit-stand test for 5 times. The shorter the time, the better the balance ability. (2) Timing test of 2.44m short distance walking. The shorter the time, the better the balance ability. (3) Balance function test, the longer the time, the better the balance ability.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
activity of daily living
Activity of Daily Living (ADL) whose total score is ranging from 14 to 56. Total score ≤26, basically normal; > 26 indicates different degree of functional decline; Score of 2 or more individual scores > 3 points, significant dysfunction.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
the word memory function
Chinese Version Verbal Learning Test (CVVLT) will be used to evaluate the word memory function of the elderly. Researchers repeated 9 words at a rate of one word per second for four times in a fixed sequence. The elderly will be asked to recall the words 30 seconds later and again 10 minutes later. In this study, only the results of the delayed free memory test at the 10th minute will be included in the later statistics. The more vocabularies remembered, the better the cognitive function.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
language functions
Boston Naming Test (BNT-30) will be used to evaluate language functions of the elderly. During the test, if the subject could make a spontaneous naming error within 20 seconds, the semantic cue will be used to prompt the subject; if the subject could not answer within 20 seconds, the subject will be given a recognition choice including three choices. The evaluation indexes include spontaneous correct naming number, prompt correct naming percentage and selection of correct naming percentage. The higher the score, the better the cognitive function.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
verbal functions
Verbal Fluency Test (VFT) will be used to assess the verbal functions of the elderly. Subjects are required to say as many animal names as possible within one minute. The test involves multiple cognitive functions such as memory, language and execution, which is the most important tool for testing subjects' language fluency. The more words they can say, the better their cognitive function.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
visuospatial structure ability and visual memory of the elderly
Rey-Osterrieth Complex Figure Test (ROCFT) will be used to asses the visuospatial structure ability and visual memory of the elderly. During the test, the elderly will be asked to copy complex images. Researchers record the copying time and remove the cards immediately after the copying completed. After 3 minutes and 30 minutes, the subjects will be asked to re-draw according to the recall, and the researchers record the duration of the instantaneous recall. Each drawing should take no more than 10 minutes. Reference standards will used to score the images of copying, instantaneous meeting and delayed recall respectively, with a total score of 36 points.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
working memory portion of the executive function
Digital Backward (DB) will be used to evaluate the working memory portion of the executive function. The elderly will be asked to read a sequence of numbers at a rate of one number per second and asked to immediately repeat the sequence in reverse order. The number of numbers in the last sequence that the subject can recite correctly is the score of the DB test.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
the executive ability and the visuospatial ability
Clock Drawing Test (CDT) will be used to evaluate the executive ability and the visuospatial ability. Subjects will be asked to draw the face of a clock and write all the numbers. The hour and minute hands point to 11:10. The clock face is complete (0-2 points), the number is complete and sequence (0-4 points), and the pointer is complete and position (0-4 points). The higher the total score is, the better the cognitive function is.
Measured: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Geriatric DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Duan Li, Chengde Medical University
- Investigators
- Li Duan, Dr., Study director, Chengde Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610917
- Sponsor's protocol ID
- ChengdeMU
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32278485Liu 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.
PubMed 33234736Liang 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.
PubMed 33765656Ngandu 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.
PubMed 25771249Chen 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.
PubMed 32134208Merchant 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.
PubMed 33887381
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05610917
- Acronym / sponsor ID
- ChengdeMU
- Conditions
- Geriatric Depression
- Keywords
- Remitted geriatric depression, Physio-cognitive decline syndrome, risk early warning mechanism, community-based rehabilitation management
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Duan LiUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group, | Experimental | Combination Product: CBRM (community-based rehabilitation management)Patients in case group will be treated with CBRM program |
| control group | Other | Combination Product: TAR(treatment as routine)the control group patients will be treated routinely as usual. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | case group, |
| TAR(treatment as routine)Patients in control group will be treated rountinely which includes drug treatment (SSRIs) and traditional health education. | Combination product | control group |
Primary outcome
depressive symptoms
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
The Hamilton Depressive Scale (HAMD-17) which consists of 17 items will be employed to screen for depressive symptoms and evaluate the mental status and severity of depressive symptoms. Scores were calculated by totaling the responses, which can be divided into four types (Health): normal/not depressed (0-7 points), mild/subthreshold (8-13), moderate/mild (14-18), severe/moderate (19-22), and severe/very severe (>23).
cognitive and intellectual function
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
Mini-mental State Examination (MMSE), as a simple screening tool for cognitive and intellectual function decline in the elderly with a total score of 30. The results of this test is closely related to the level of education, and the normal cutoff is defined as, illiterates >17 points, primary schools >20 points, and middle schools and above >24 points.
changes of the handgrip strength
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
The grip strength of a man's dominant hand < 28kg or a woman < 18kg is considered to have weak grip strength. The grip strength increased compared with the baseline period, that is, the subjects' physiological function tended to recover; Instead, physiological function tends to decline.
changes of the gait speed
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
The time it takes for the subject to walk 6 meters at normal pace from the starting point without slowing down, with a threshold for gait deceleration set to < 1m/s. The gait speed increased compared with the baseline period, that is, the subjects' physiological function tended to recover; Instead, physiological function tends to decline.
10 secondary outcomes
quality of life of the elderly
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
sleep quality
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
the balance ability of the elderly
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
activity of daily living
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
the word memory function
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
language functions
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
verbal functions
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
visuospatial structure ability and visual memory of the elderly
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
working memory portion of the executive function
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
the executive ability and the visuospatial ability
Time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Results publication: PubMed 32278485Chen 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.
- Results publication: PubMed 33234736Liu 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.
- Results publication: PubMed 33765656Liang 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.
- Results publication: PubMed 25771249Ngandu 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.
- Results publication: PubMed 32134208Chen 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.
- Results publication: PubMed 33887381Merchant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Duan, Dr. study director
Chengde Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CBRM (community-based rehabilitation management) and TAR(treatment as routine) in people with Geriatric Depression, run by Duan Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Duan, Dr. (86-13831425750, dfhedianren@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depressive symptoms (time frame: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610917, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.