Mild Cognitive Impairment Clinical Trial
— SYNERGICOfficial title:
SYNchronizing Exercises, Remedies in GaIt and Cognition (SYNERGIC): A Randomized Controlled Double Blind Trial
NCT number | NCT02808676 |
Other study ID # | 107670 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 14, 2016 |
Est. completion date | November 24, 2020 |
Verified date | September 2021 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed SYNERGIC trial is uniquely designed to evaluate the effect of aerobic and progressive resistance training exercises, combined with cognitive training and Vitamin D3 supplementation, in cognition and mobility in older adults with Mild Cognitive Impairment (MCI).
Status | Terminated |
Enrollment | 176 |
Est. completion date | November 24, 2020 |
Est. primary completion date | November 24, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: 1. At least 60 years of age 2. Self-reported levels of proficiency in English (French for Montreal site only) for speaking and understanding spoken language. 3. Able to comply with scheduled visits, treatment plan, and other trial procedures 4. Able to ambulate at least 10 meters independently 5. Having MCI operationalized using Albert et al. criteria as: - objective cognitive impairment in one of the following four cognitive domains: memory, executive function, attention, and language evaluated by the Montreal Cognitive Assessment (MoCA) test with scores ranging from 13-24/30. - Preserved activities of daily living on the disability scale confirmed by clinician interview 6. Having normal or corrected to normal vision in at least one eye so that they can identify symbols and stimuli presented on a computer screen in front of them. 7. Must be in sufficient health to participate in the study's aerobic-based exercise training program, based on medical history, vital signs, physical examination by study physicians, or written recommendation by family physician indicating one's appropriateness to participate in aerobic-based exercise training program. Exclusion Criteria: 1. Serious underlying disease (such as active cancer, or recent heart attack) which, in the opinion of the investigator, may preclude engagement in interventions or may interfere with the participant's ability to participate fully in the study. 2. Diagnosis of dementia using criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. 3. Participant with uncontrolled major depression, schizophrenia, severe anxiety and substance abuse. 4. Current parkinsonism or any neurological disorder with residual motor deficits (e.g. stroke with motor deficit), active musculo-skeletal disorders (e.g. severe osteoarthritis of lower limbs) or history of knee/hip replacement affecting gait performance at clinical evaluation. 5. Intention to enroll in other clinical trials during the same time period 6. Pre-existing exercise structured training program involving aerobic or resistance training in previous 6 months. 7. Taking cognitive enhancers, neuroleptics, anticholinergics or Vitamin D3 in doses more than 1000IU/day or equivalent. |
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Health Care London, Parkwood Hospital | London | Ontario |
Canada | Université de Montréal | Montréal | Quebec |
Canada | University of British Columbia | Vancouver | British Columbia |
Canada | University of Waterloo | Waterloo | Ontario |
Canada | Wilfrid Laurier University | Waterloo | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in global cognition assessed using the ADASCog(13 and Plus modalities). | Global cognition will be assessed using the cognitive section of the Alzheimer Disease Assessment Scale-plus EF+FA (ADAS-Cog-plus). This scale consists of 10 brief cognitive tests assessing memory, language, executive function, praxis, and instrumental activities of daily living. The ADAS-Cog has been a significant outcome measure in numerous trials with MCI and AD. The ADAS-Cog-plus has marked advantages as an outcome measure in MCI populations since incorporates items concerning executive function (EF) and functional abilities (FA). Scores in the ADASCog-plus (EF+FA) range from 0 to 90, with higher scores indicating better cognitive performance. | baseline and at 20 weeks (after interventions finalised) | |
Secondary | Change in cognition assessed as the CCNA Cognitive Battery. | The Canadian Consortium on Neurodegeneration in Ageing (CCNA) has established a battery of neuropsychological test which will used as secondary outcomes | baseline at 20 weeks (after interventions finalised) | |
Secondary | Change in gait velocity (cm/s). | Gait will be assessed under single and dual-task conditions | baseline at 20 weeks (after interventions finalised) | |
Secondary | Change in gait variability (%CoV). | Gait will be assessed under single and dual-task conditions | baseline at 20 weeks (after interventions finalised) | |
Secondary | Brain structure (sMRI) | Structural 3 Tesla MRI will be performed at baseline and 20 weeks in all participants who do no present contra-indication for imaging studies | baseline and at 20 weeks (after interventions finalised) | |
Secondary | Brain function (fMRI) | Functional 3 Tesla MRI will be performed at baseline and at 20 weeks 6 in all participants who do no present contra-indication for imaging studies. | baseline and at 20 weeks (after interventions finalised) | |
Secondary | Changes in BDNF serum levels | Changes in brain derived neurotrophic factor (BDNF) serum levels will be assessed and measured in international units | baseline and at 20 weeks (after interventions finalised) | |
Secondary | Combined Score of Cognition and Functionality (Pooled Index) | This index will include cognitive test, gait velocity, dual task gait and the ability to perform activities of daily living. Therefore, treatments are considered successful if they slow down the progression of cognitive decline and maintain functionality and independency | baseline and at 20 weeks (after interventions finalised) | |
Secondary | Changes in serum levels Interleukin 1. | Changes in IL-1 will be assessed in serum and measured in international units. | baseline and at 20 weeks (after interventions finalised) | |
Secondary | Changes in serum levels Interleukin 6. | Changes in IL-6 will be assessed in serum and measured in international units. | baseline and at 20 weeks (after interventions finalised) | |
Secondary | Changes in serum High Sensitive C reactive protein (CRP). | Serum levels of C reactive protein (CRP) 1 will be determined by standardized ELISA methods. | baseline and at 20 weeks (after interventions finalised). | |
Secondary | Changes in serum levels of VEGF receptor 1. | Serum levels of VEGF receptor 1 will be determined by standardized ELISA methods. | baseline and at 20 weeks (after interventions finalised) |
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