Mild Cognitive ImpairmentSYNERGICNCT02808676
SYNchronizing Exercises, Remedies in GaIt and Cognition
A study testing Vitamin D3, Exercises (E) and Cognitive Training (CT) in people with Mild Cognitive Impairment, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 6 sites in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Vitamin D3, Exercises (E) and Cognitive Training (CT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 6 sitesCanada
- Study dates
- 14 Jul 2016to 24 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 60 years of age
- Self-reported levels of proficiency in English (French for Montreal site only) for speaking and understanding spoken language.
- Able to comply with scheduled visits, treatment plan, and other trial procedures
- Able to ambulate at least 10 meters independently
- 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.
Show all 9Show fewer
- Preserved activities of daily living on the disability scale confirmed by clinician interview
- 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.
- 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.
Who cannot join
- 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.
- Diagnosis of dementia using criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
- Participant with uncontrolled major depression, schizophrenia, severe anxiety and substance abuse.
- 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.
- Intention to enroll in other clinical trials during the same time period
- Pre-existing exercise structured training program involving aerobic or resistance training in previous 6 months.
- Taking cognitive enhancers, neuroleptics, anticholinergics or Vitamin D3 in doses more than 1000IU/day or equivalent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
St. Joseph's Health Care London, Parkwood Hospital
London, Ontario, N6C5J1
Concordia University
Montreal, Quebec
Institut Universitaire de Gériatrie de Montréal
Montreal, Quebec
University of British Columbia
Vancouver, British Columbia
University of Waterloo
Waterloo, Ontario
Wilfrid Laurier University
Waterloo, Ontario
About this study
Official title: SYNchronizing Exercises, Remedies in GaIt and Cognition (SYNERGIC): A Randomized Controlled Double Blind Trial
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).
Read the detailed description
Exercises, specifically resistance and aerobic training, have been demonstrated to improve cognitive outcomes, along with improved physical capacity and mobility. Both aerobic and resistance training trials of different duration have revealed positive results, with the most consistent findings being observed after combined interventions of 6 months to one year. Although the training benefits of progressive resistance training (PRT) have been well documented, PRT has been studied far less extensively in older adults with Mild Cognitive Impairment (MCI). Exercise training has proven to be beneficial for cognition even in vulnarable populations like in frail older adults, and those with mobility issues. The exact mechanism supporting the benefits of exercise for cognition in humans needs to be further explored, as numerous studies in animals and humans have demonstrated that aerobic exercise may have neuroprotective and neurorestorative effects. The rationale of combining aerobic and PRT as multimodal exercise intervention is supported by research that has revealed potential beneficial effects. In addition, multimodal exercise interventions have shown positive effects on muscle/lean mass, cognition and brain structure, functionality, and brain volume.
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
- Mild Cognitive Impairment
- Being tested
- Vitamin D3, Exercises (E), Cognitive Training (CT), placebo D3, control cognitive training
- Keywords
- Cognitive training, Vitamin D, Exercise
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
Dose: 10000 IU, three times per week, orally.
Exercises (E)Other
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)Other
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 D3Other
matching placebo for Vitamin D3
control cognitive trainingOther
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 exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Exercises+CognitiveTraining+Vitamin D3 | Experimental | 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. Receives: Dietary Supplement: Vitamin D3; Other: Exercises (E); Other: Cognitive Training (CT) |
| Exercises+CognitiveTraining+Placebo D3 | Experimental | 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. Receives: Other: Exercises (E); Other: Cognitive Training (CT); Other: placebo D3 |
| Exercises+Control CogTraining+Vitamin D3 | Experimental | 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 Receives: Dietary Supplement: Vitamin D3; Other: Exercises (E); Other: control cognitive training |
| Exercises+Control CogTraining+Placebo D3 | Experimental | 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. Receives: Other: Exercises (E); Other: placebo D3; Other: control cognitive training |
| Placebo exercise+Control Cog+Placebo D3 | Placebo comparator | This will be the comparator arm with control/placebo activities. Receives: Other: placebo D3; Other: control cognitive training; Other: Placebo exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and at 20 weeks (after interventions finalised)
Secondary outcomes (4)
Change in Cognition Assessed as the CCNA Cognitive Battery.
The Canadian Consortium on Neurodegeneration in Aging (CCNA) has established a battery of neuropsychological test which will used as secondary outcomes e.g., ADAS-Cog-13, which is scored from 0 to 70, with higher scores indicating greater cognitive impairment.
Measured: baseline at 20 weeks (after interventions finalised)
Falls Incidence
Frequency and circumstances of falls over the study period.
Measured: baseline at 20 weeks (after interventions finalised)
Gait Velocity - cm/s
Assessment of usual and fast-paced walking to evaluate mobility performance.
Measured: baseline at 20 weeks (after interventions finalised)
Gait Variability Which is Calculated as Coefficient of Variation (CoV)
A higher CoV indicates greater variability, which has been associated with increased fall risk and impaired motor control, particularly in individuals with Mild Cognitive Impairment (MCI
Measured: baseline at 20 weeks (after interventions finalised)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start14 Jul 2016
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Why it stopped: Due to the COVID-19 pandemic, in-person interventions/assessments no longer possible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel M Montero-Odasso, MD, PhD, Study chair, Gait and Brain Lab, Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808676
- Sponsor's protocol ID
- 107670
- Acronym
- SYNERGIC
- Status last verified
- Feb 2024
- First submitted
- 6 Jun 2016
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24163767Liu-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.
PubMed 21741129Colcombe 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.
PubMed 12661673Langlois 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.
PubMed 22929394Sage 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.
PubMed 19938164Sage 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.
PubMed 19373930Cotman 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.
PubMed 17765329Nagamatsu 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.
PubMed 22529236Kueider 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.
PubMed 22792378Reijnders 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.
PubMed 22841936Ballesteros 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.
PubMed 25352805Chapman 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.
PubMed 23985135Annweiler 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.
PubMed 22423308Beauchet 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.
PubMed 21471466Annweiler 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.
PubMed 21079183
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYNchronizing Exercises, Remedies in GaIt and Cognition (SYNERGIC): A Randomized Controlled Double Blind Trial
- ClinicalTrials.gov ID
- NCT02808676
- Acronym / sponsor ID
- SYNERGIC / 107670
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognitive training, Vitamin D, Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 pandemic, in-person interventions/assessments no longer possible.
- Enrolment
- 175 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Exercises, specifically resistance and aerobic training, have been demonstrated to improve cognitive outcomes, along with improved physical capacity and mobility. Both aerobic and resistance training trials of different duration have revealed positive results, with the most consistent findings being observed after combined interventions of 6 months to one year. Although the training benefits of progressive resistance training (PRT) have been well documented, PRT has been studied far less extensively in older adults with Mild Cognitive Impairment (MCI). Exercise training has proven to be beneficial for cognition even in vulnarable populations like in frail older adults, and those with mobility issues. The exact mechanism supporting the benefits of exercise for cognition in humans needs to be further explored, as numerous studies in animals and humans have demonstrated that aerobic exercise may have neuroprotective and neurorestorative effects. The rationale of combining aerobic and PRT as multimodal exercise intervention is supported by research that has revealed potential beneficial effects. In addition, multimodal exercise interventions have shown positive effects on muscle/lean mass, cognition and brain structure, functionality, and brain volume.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Exercises+CognitiveTraining+Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3, Other: Exercises (E), Other: Cognitive Training (CT)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. |
| Exercises+CognitiveTraining+Placebo D3 | Experimental | Other: Exercises (E), Other: Cognitive Training (CT), Other: placebo D3Exercises 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+Control CogTraining+Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3, Other: Exercises (E), Other: control cognitive trainingExercises 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 |
| Exercises+Control CogTraining+Placebo D3 | Experimental | Other: Exercises (E), Other: placebo D3, Other: control cognitive trainingExercises 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. |
| Placebo exercise+Control Cog+Placebo D3 | Placebo comparator | Other: placebo D3, Other: control cognitive training, Other: Placebo exerciseThis will be the comparator arm with control/placebo activities. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 60 years of age
- Self-reported levels of proficiency in English (French for Montreal site only) for speaking and understanding spoken language.
- Able to comply with scheduled visits, treatment plan, and other trial procedures
- Able to ambulate at least 10 meters independently
- Having MCI operationalized using Albert et al. criteria as:
Key exclusion criteria (7 listed)
- 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.
- Diagnosis of dementia using criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
- Participant with uncontrolled major depression, schizophrenia, severe anxiety and substance abuse.
- 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.
- Intention to enroll in other clinical trials during the same time period
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 |
|---|---|---|
| Vitamin D3Also: CholecalciferolDose: 10000 IU, three times per week, orally. | Dietary supplement | Exercises+CognitiveTraining+Vitamin D3, Exercises+Control CogTraining+Vitamin D3 |
| 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. | Other | Exercises+CognitiveTraining+Placebo D3, Exercises+CognitiveTraining+Vitamin D3, Exercises+Control CogTraining+Placebo D3, Exercises+Control CogTraining+Vitamin D3 |
| 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). | Other | Exercises+CognitiveTraining+Placebo D3, Exercises+CognitiveTraining+Vitamin D3 |
| placebo D3matching placebo for Vitamin D3 | Other | Exercises+CognitiveTraining+Placebo D3, Exercises+Control CogTraining+Placebo D3, Placebo exercise+Control Cog+Placebo D3 |
| control cognitive trainingAs 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. | Other | Exercises+Control CogTraining+Placebo D3, Exercises+Control CogTraining+Vitamin D3, Placebo exercise+Control Cog+Placebo D3 |
| Placebo exerciseAs 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 | Placebo exercise+Control Cog+Placebo D3 |
Primary outcome
Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities).
Time frame: baseline and at 20 weeks (after interventions finalised)
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.
4 secondary outcomes
Change in Cognition Assessed as the CCNA Cognitive Battery.
Time frame: baseline at 20 weeks (after interventions finalised)
Falls Incidence
Time frame: baseline at 20 weeks (after interventions finalised)
Gait Velocity - cm/s
Time frame: baseline at 20 weeks (after interventions finalised)
Gait Variability Which is Calculated as Coefficient of Variation (CoV)
Time frame: baseline at 20 weeks (after interventions finalised)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24163767Bherer 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.
- Background: PubMed 21741129Liu-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.
- Background: PubMed 12661673Colcombe 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.
- Background: PubMed 22929394Langlois 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.
- Background: PubMed 19938164Sage 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.
- Background: PubMed 19373930Sage 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.
- Background: PubMed 17765329Cotman 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.
- Background: PubMed 22529236Nagamatsu 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.
- Background: PubMed 22792378Kueider 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.
- Background: PubMed 22841936Reijnders 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.
- Background: PubMed 25352805Ballesteros 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.
- Background: PubMed 23985135Chapman 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.
- 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.
Manuel M Montero-Odasso, MD, PhD study chair
Gait and Brain Lab, Lawson Health Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3, Exercises (E) and Cognitive Training (CT) in people with Mild Cognitive Impairment, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 6 sites in Canada.
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 9 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: stopped early, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (time frame: baseline and at 20 weeks (after interventions finalised)). 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 NCT02808676, which also lists 28 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 21 Feb 2025.