SYNchronizing Exercises, Remedies in GaIt and Cognition
NCT ID: NCT02808676
Last Updated: 2025-02-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
175 participants
INTERVENTIONAL
2016-07-14
2020-11-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SYNERGIC-2 Trial (SYNchronizing, Exercises and Remedies to GaIn Cognition@home)
NCT05375513
Study of the Effect of SR57667B in Patients With Alzheimer's Disease
NCT00285025
Pioglitazone Or Exercise to Treat Mild Cognitive Impairment (MCI)
NCT00736996
Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)
NCT04730635
Open-label Extension Study in Participants With Early Alzheimer's Disease
NCT07105709
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Similarly cognitive training, i.e. computer based cognitive process training, has also shown positive results in improving cognition, mobility, and postural control. Several recent systematic reviews on the topic support the benefits of cognitive training. In line with exercise training, recent research on cognitive training has also supported important improvements in brain plasticity post-intervention.
Finally, Vitamin D3 deficiency in older adults has been linked to cognitive dysfunction, dementia, and mobility decline. Besides its very well-known effects on muscle and bone physiology, several studies have shown a potential beneficial role of Vitamin D3 on cognitive function. Robustly designed trials, with longitudinal follow-up, have been recommended in older adults with MCI to investigate the comparative benefits of isolated Vitamin D3 supplementation, and combined with physical and cognitive training.
To date, the effect of adding cognitive training and/or Vitamin D3 to a multimodal progressive exercise training for improving global cognition, executive function, memory, and gait in MCI has not been assessed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercises+CognitiveTraining+Vitamin D3
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks.
Vitamin D3
Dose: 10000 IU, three times per week, orally.
Exercises (E)
All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
Cognitive Training (CT)
CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
Exercises+CognitiveTraining+Placebo D3
Exercises will combine aerobic+resistance training. Cognitive training will be performed before exercise intervention and using using an "ad-hoc" software developed by us for tablets. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E)
All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
Cognitive Training (CT)
CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
placebo D3
matching placebo for Vitamin D3
Exercises+Control CogTraining+Vitamin D3
Exercises will combine aerobic+resistance training. Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc.). Vitamin D3 (10000IU) will be provided orally three time per week for 20 weeks
Vitamin D3
Dose: 10000 IU, three times per week, orally.
Exercises (E)
All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
control cognitive training
As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
Exercises+Control CogTraining+Placebo D3
Exercises will combine aerobic+resistance training.Control cognitive training will be performed before exercise intervention and will consist in computer skills training courses. Each session will consist of introductory exercises for computers and different software (e.g., Word, Excel), as well as an initiation to the Internet (search engines, websites, games, etc. Matching placebo of vitamin D3 will be provided orally three time per week for 20 weeks.
Exercises (E)
All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
placebo D3
matching placebo for Vitamin D3
control cognitive training
As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
Placebo exercise+Control Cog+Placebo D3
This will be the comparator arm with control/placebo activities.
placebo D3
matching placebo for Vitamin D3
control cognitive training
As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
Placebo exercise
As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 60 min of a tone exercise regimen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vitamin D3
Dose: 10000 IU, three times per week, orally.
Exercises (E)
All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
Cognitive Training (CT)
CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
placebo D3
matching placebo for Vitamin D3
control cognitive training
As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
Placebo exercise
As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 60 min of a tone exercise regimen
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Manuel M Montero-Odasso, MD, PhD
Role: STUDY_CHAIR
Gait and Brain Lab, Lawson Health Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of British Columbia
Vancouver, British Columbia, Canada
St. Joseph's Health Care London, Parkwood Hospital
London, Ontario, Canada
University of Waterloo
Waterloo, Ontario, Canada
Wilfrid Laurier University
Waterloo, Ontario, Canada
Concordia University
Montreal, Quebec, Canada
Institut Universitaire de Gériatrie de Montréal
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bherer L, Erickson KI, Liu-Ambrose T. Physical exercise and brain functions in older adults. J Aging Res. 2013;2013:197326. doi: 10.1155/2013/197326. Epub 2013 Sep 17. No abstract available.
Liu-Ambrose T, Nagamatsu LS, Voss MW, Khan KM, Handy TC. Resistance training and functional plasticity of the aging brain: a 12-month randomized controlled trial. Neurobiol Aging. 2012 Aug;33(8):1690-8. doi: 10.1016/j.neurobiolaging.2011.05.010. Epub 2011 Jul 7.
Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28.
Sage MD, Almeida QJ. A positive influence of vision on motor symptoms during sensory attention focused exercise for Parkinson's disease. Mov Disord. 2010 Jan 15;25(1):64-9. doi: 10.1002/mds.22886.
Sage MD, Almeida QJ. Symptom and gait changes after sensory attention focused exercise vs aerobic training in Parkinson's disease. Mov Disord. 2009 Jun 15;24(8):1132-8. doi: 10.1002/mds.22469.
Cotman CW, Berchtold NC, Christie LA. Exercise builds brain health: key roles of growth factor cascades and inflammation. Trends Neurosci. 2007 Sep;30(9):464-72. doi: 10.1016/j.tins.2007.06.011. Epub 2007 Aug 31.
Nagamatsu LS, Handy TC, Hsu CL, Voss M, Liu-Ambrose T. Resistance training promotes cognitive and functional brain plasticity in seniors with probable mild cognitive impairment. Arch Intern Med. 2012 Apr 23;172(8):666-8. doi: 10.1001/archinternmed.2012.379. No abstract available.
Kueider AM, Parisi JM, Gross AL, Rebok GW. Computerized cognitive training with older adults: a systematic review. PLoS One. 2012;7(7):e40588. doi: 10.1371/journal.pone.0040588. Epub 2012 Jul 11.
Reijnders J, van Heugten C, van Boxtel M. Cognitive interventions in healthy older adults and people with mild cognitive impairment: a systematic review. Ageing Res Rev. 2013 Jan;12(1):263-75. doi: 10.1016/j.arr.2012.07.003. Epub 2012 Jul 25.
Ballesteros S, Prieto A, Mayas J, Toril P, Pita C, Ponce de Leon L, Reales JM, Waterworth J. Brain training with non-action video games enhances aspects of cognition in older adults: a randomized controlled trial. Front Aging Neurosci. 2014 Oct 14;6:277. doi: 10.3389/fnagi.2014.00277. eCollection 2014.
Chapman SB, Aslan S, Spence JS, Hart JJ Jr, Bartz EK, Didehbani N, Keebler MW, Gardner CM, Strain JF, DeFina LF, Lu H. Neural mechanisms of brain plasticity with complex cognitive training in healthy seniors. Cereb Cortex. 2015 Feb;25(2):396-405. doi: 10.1093/cercor/bht234. Epub 2013 Aug 28.
Annweiler C, Montero-Odasso M, Muir SW, Beauchet O. Vitamin D and Brain Imaging in the Elderly: Should we Expect Some Lesions Specifically Related to Hypovitaminosis D? Open Neuroimag J. 2012;6:16-8. doi: 10.2174/1874440001206010016. Epub 2012 Feb 28.
Beauchet O, Annweiler C, Verghese J, Fantino B, Herrmann FR, Allali G. Biology of gait control: vitamin D involvement. Neurology. 2011 May 10;76(19):1617-22. doi: 10.1212/WNL.0b013e318219fb08. Epub 2011 Apr 6.
Annweiler C, Schott AM, Rolland Y, Blain H, Herrmann FR, Beauchet O. Dietary intake of vitamin D and cognition in older women: a large population-based study. Neurology. 2010 Nov 16;75(20):1810-6. doi: 10.1212/WNL.0b013e3181fd6352.
Montero-Odasso M, Bherer L, Studenski S, Gopaul K, Oteng-Amoako A, Woolmore-Goodwin S, Stoole P, Wells J, Doherty T, Zecevic AA, Galinsky D, Rylett RJ, Jutai J, Muir-Hunter S, Speechley M, Camicioli R. Mobility and Cognition in Seniors. Report from the 2008 Institute of Aging (CIHR) Mobility and Cognition Workshop. Can Geriatr J. 2015 Sep 30;18(3):159-67. doi: 10.5770/cgj.18.188. eCollection 2015 Sep.
Annweiler C, Beauchet O, Bartha R, Hachinski V, Montero-Odasso M; WALK Team (Working group Angers-London for Knowledge). Vitamin D and caudal primary motor cortex: a magnetic resonance spectroscopy study. PLoS One. 2014 Jan 31;9(1):e87314. doi: 10.1371/journal.pone.0087314. eCollection 2014.
Montero-Odasso M, Hachinski V. Preludes to brain failure: executive dysfunction and gait disturbances. Neurol Sci. 2014 Apr;35(4):601-4. doi: 10.1007/s10072-013-1613-4. Epub 2013 Dec 24.
Montero-Odasso M, Verghese J, Beauchet O, Hausdorff JM. Gait and cognition: a complementary approach to understanding brain function and the risk of falling. J Am Geriatr Soc. 2012 Nov;60(11):2127-36. doi: 10.1111/j.1532-5415.2012.04209.x. Epub 2012 Oct 30.
Skinner J, Carvalho JO, Potter GG, Thames A, Zelinski E, Crane PK, Gibbons LE; Alzheimer's Disease Neuroimaging Initiative. The Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-Plus): an expansion of the ADAS-Cog to improve responsiveness in MCI. Brain Imaging Behav. 2012 Dec;6(4):489-501. doi: 10.1007/s11682-012-9166-3.
Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
Fraser SA, Li KZ, DeMont RG, Penhune VB. Effects of balance status and age on muscle activation while walking under divided attention. J Gerontol B Psychol Sci Soc Sci. 2007 May;62(3):P171-8. doi: 10.1093/geronb/62.3.p171.
Montero-Odasso M, Zou G, Speechley M, Almeida QJ, Liu-Ambrose T, Middleton LE, Camicioli R, Bray NW, Li KZH, Fraser S, Pieruccini-Faria F, Berryman N, Lussier M, Shoemaker JK, Son S, Bherer L; Canadian Gait and Cognition Network. Effects of Exercise Alone or Combined With Cognitive Training and Vitamin D Supplementation to Improve Cognition in Adults With Mild Cognitive Impairment: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2324465. doi: 10.1001/jamanetworkopen.2023.24465.
Bray NW, Pieruccini-Faria F, Witt ST, Rockwood K, Bartha R, Doherty TJ, Nagamatsu LS, Almeida QJ, Liu-Ambrose T, Middleton LE, Bherer L, Montero-Odasso M. Frailty and functional brain connectivity (FBC) in older adults with mild cognitive impairment (MCI): baseline results from the SYNERGIC Trial. Geroscience. 2023 Apr;45(2):1033-1048. doi: 10.1007/s11357-022-00702-4. Epub 2022 Dec 21.
Bray NW, Pieruccini-Faria F, Witt ST, Bartha R, Doherty TJ, Nagamatsu LS, Almeida QJ, Liu-Ambrose T, Middleton LE, Bherer L, Montero-Odasso M. Combining exercise with cognitive training and vitamin D3 to improve functional brain connectivity (FBC) in older adults with mild cognitive impairment (MCI). Results from the SYNERGIC trial. Geroscience. 2023 Jun;45(3):1967-1985. doi: 10.1007/s11357-023-00805-6. Epub 2023 May 10.
Montero-Odasso M, Almeida QJ, Burhan AM, Camicioli R, Doyon J, Fraser S, Li K, Liu-Ambrose T, Middleton L, Muir-Hunter S, McIlroy W, Morais JA, Pieruccini-Faria F, Shoemaker K, Speechley M, Vasudev A, Zou GY, Berryman N, Lussier M, Vanderhaeghe L, Bherer L. SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment. BMC Geriatr. 2018 Apr 16;18(1):93. doi: 10.1186/s12877-018-0782-7.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
107670
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.