SYNchronizing Exercises, Remedies in GaIt and Cognition

NCT02808676 | Terminated Results

• 1 other identifier: 107670
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Mild Cognitive Impairment

Keywords

Cognitive training; Vitamin D; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Cognition Assessed as the CCNA Cognitive Battery.

  baseline at 20 weeks (after interventions finalised)

• Falls Incidence

  baseline at 20 weeks (after interventions finalised)

• Gait Velocity - cm/s

  baseline at 20 weeks (after interventions finalised)

• Gait Variability Which is Calculated as Coefficient of Variation (CoV)

  baseline at 20 weeks (after interventions finalised)

Study Arms (5)

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.

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.

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

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.

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.

Other: placebo D3; Other: control cognitive training; Other: Placebo exercise

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Dose: 10000 IU, three times per week, orally.

Also known as: Cholecalciferol

Exercises+CognitiveTraining+Vitamin D3; Exercises+Control CogTraining+Vitamin D3

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.

Exercises+CognitiveTraining+Placebo D3; Exercises+CognitiveTraining+Vitamin D3; Exercises+Control CogTraining+Placebo D3; Exercises+Control CogTraining+Vitamin D3

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).

Exercises+CognitiveTraining+Placebo D3; Exercises+CognitiveTraining+Vitamin D3

placebo D3 OTHER

matching placebo for Vitamin D3

Exercises+CognitiveTraining+Placebo D3; Exercises+Control CogTraining+Placebo D3; Placebo exercise+Control Cog+Placebo D3

control cognitive training OTHER

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+Control CogTraining+Vitamin D3; Placebo exercise+Control Cog+Placebo D3

Placebo exercise OTHER

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

Placebo exercise+Control Cog+Placebo D3

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (6)

University of British Columbia

Vancouver, British Columbia, Canada

Location

St. Joseph's Health Care London, Parkwood Hospital

London, Ontario, N6C5J1, Canada

Location

University of Waterloo

Waterloo, Ontario, Canada

Location

Wilfrid Laurier University

Waterloo, Ontario, Canada

Location

Concordia University

Montreal, Quebec, Canada

Location

Institut Universitaire de Gériatrie de Montréal

Montreal, Quebec, Canada

Location

Related Publications (26)

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• 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.

  PMID: 21741129 BACKGROUND

• 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.

  PMID: 12661673 BACKGROUND

• 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.

  PMID: 22929394 BACKGROUND

• 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.

  PMID: 19938164 BACKGROUND

• 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.

  PMID: 19373930 BACKGROUND

• 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.

  PMID: 17765329 BACKGROUND

• 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.

  PMID: 22529236 BACKGROUND

• 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.

  PMID: 22792378 BACKGROUND

• 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.

  PMID: 22841936 BACKGROUND

• 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.

  PMID: 25352805 BACKGROUND

• 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.

  PMID: 23985135 BACKGROUND

• 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.

  PMID: 22423308 BACKGROUND

• 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.

  PMID: 21471466 BACKGROUND

• 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.

  PMID: 21079183 BACKGROUND

• 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.

  PMID: 26495050 BACKGROUND

• 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.

  PMID: 24498072 BACKGROUND

• 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.

  PMID: 24366243 BACKGROUND

• 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.

  PMID: 23110433 BACKGROUND

• 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.

  PMID: 22614326 BACKGROUND

• 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.

  PMID: 21514249 BACKGROUND

• 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.

  PMID: 17507585 BACKGROUND

• 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.

  PMID: 37471089 BACKGROUND

• 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.

  PMID: 36539590 BACKGROUND

• 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.

  PMID: 37162700 BACKGROUND

• 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.

  PMID: 29661156 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Interventions

Cholecalciferol; Exercise; Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Manuel Montero-Odasso
• Organization: Lawson Health Research Institute

manuel.monteroodasso@sjhc.london.on.ca

519-685-4292

Study Officials

• Manuel M Montero-Odasso, MD, PhD

  Gait and Brain Lab, Lawson Health Research Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 22, 2016
• Study Start: July 14, 2016
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)