SYNchronizing Exercises, Remedies in Gait and Cognition at Home (SYNERGIC@Home)
SYNERGIC@Hom
1 other identifier
interventional
60
1 country
1
Brief Summary
Background: Prevention of Alzheimer's Disease and Related Dementias (ADRDs) may be possible for persons with subjective (SCI) or mild cognitive impairment (MCI), or normal cognition and risk factors. Physical exercise and cognitive training have been shown to enhance cognitive function and mobility in MCI when delivered in a research facility. The feasibility of delivering interventions in the home of older adults at risk for developing ADRDs is not known. What preferences the participants have for these interventions are also unknown. The primary goals are: 1) assess feasibility of a home-based delivery of exercise and cognitive interventions 2) evaluate the relationship between participants' intervention preferences and adherence. Secondary objectives focus on cognition, frailty, mobility, sleep, diet and mental health. Methods and analysis: SYNERGIC@Home is a randomized control trial (using a 2 x 2 factorial design) with a 16-week home-based intervention program of physical exercises with cognitive training. Sixty-four participants will be randomized in blocks of four: 1) combined exercise (aerobic and resistance) + cognitive training (NEUROPEAK™); 2) combined exercise + control cognitive training (web searching); 3) control exercise (balance and toning) + cognitive training; and 4) control exercise + control cognitive training. It will be implemented virtually through video conferencing. Baseline, 4- and 10-month post-intervention will include measures of cognition, frailty, mobility, sleep, diet, and psychological health. Feasibility outcomes include recruitment and retention. Preference will be used to determine the relationship between preference adherence. Secondary outcomes will evaluate the effect of the interventions on cognitive, mobility, and general well-being.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedStudy Start
First participant enrolled
July 28, 2021
CompletedFirst Posted
Study publicly available on registry
August 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2023
CompletedOctober 2, 2023
September 1, 2023
1.6 years
June 1, 2021
September 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Intervention Adherence
Defined as the mean percent of all Intervention sessions attended of the 48 planned sessions per participant.
Post-intervention at 4 months
Intervention Preference
The primary analytic goal of SYNERGIC@Home is to assess the relationship between participants' adherence to the interventions and their affinity for each intervention going into the trial. All participants will be given the Intervention Preference Questionnaire (IPQ) prior to implementation of the intervention
Baseline
Secondary Outcomes (64)
Recruitment Rate
Through study completion, an average of 10 months
Retention Rate
Through study completion, an average of 10 months
Assessment Tolerability
Baseline
Trial Experience
10 months follow-up
Adverse Events
Monitored from start of study until end of study
- +59 more secondary outcomes
Study Arms (4)
Exercise Intervention Training and Cognitive Intervention Training
EXPERIMENTALCombined Aerobic Exercise and Resistance Training (AE + RT) + Cognitive Training (NeuropeakTM)
Exercise Intervention Training and Control Cognitive Training
ACTIVE COMPARATORCombined Aerobic Exercise and Resistance Training (AE + RT) + Control Cognitive Training of Website Searching and Video Watching (WS+V)
Control Exercise Training and Cognitive Intervention Training
ACTIVE COMPARATORControl Balance and Toning Exercise Training (BAT) + Cognitive Training (NeuropeakTM)
Control Exercise Training and Control Cognitive Training
PLACEBO COMPARATORControl Balance and Toning Exercise Training (BAT) + Control Cognitive Training of Website Searching and Video Watching (WS+V)
Interventions
AE + RT will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. AE + RT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 strength training exercises (that progressively increase in resistance intensity over time) will be completed followed by a break. Aerobic exercises that safely increase the participant's heart rate will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the AE + RT exercise session is approximately 65 minutes.
NeuropeakTM is a program which will be completed by participants remotely using a tablet or computer. It consists of cognitive training including dual-task training that requires participants to maintain and prepare for many response alternatives (working memory) and to share attention between two concurrent tasks (divided attention). Difficulty of cognitive training is tailored to their individual functioning level. During each session, participants perform one of two different visuo-motor tasks, which include sets of visual stimuli (e.g., letters, numbers, animals, vehicles, fruits, celestial bodies) and respective hand-button correspondences (i.e., keys that are to be tapped on either the right or the left side of the screen). Participants are instructed to perform these tasks as fast as possible, while maintaining accuracy. Training also includes online feedback and a histogram of daily performance to encourage improvement. NeuropeakTM takes approximately 30 minutes to complete.
During the WS + V task, participants alternate between 2 different tasks (touristic searching using internet and video watching). For the touristic searching using internet, participants are required to find 3 hotels, 3 touristic places, and 3 restaurants of their own preference in a city assigned by the instructor (a new city will be selected each session). They will also need to include the respective addresses of those places on their log sheet. For the video watching task, participants watch a National Geographic video on YouTube selected by the instructor with a different video selected for each session. They will watch the video for 20 minutes and during the remaining 5 minutes they will answer the following questions on their log sheet: 1) What is the video about? 2) What is the most important information in your opinion? 3) Create a question based on the video and answer your own question. WS + V sessions take approximately 30 minutes to complete.
BAT exercises will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. BAT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 balance and toning exercises will be completed followed by a break. Stretching exercises will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the BAT exercise session is approximately 65 minutes.
Eligibility Criteria
You may qualify if:
- Age 60 to 90 years old.
- Has a Family Physician
- Has internet access (and have regular access to email), and the technology ability (able to send and receive emails).
- Resides in their own home/apartment in the community.
- Has access to a home computer and/or a tablet computer device.
- Self-reported levels of proficiency in English and/or French for speaking and understanding spoken and written language.
- Able to comply with scheduled home-based assessments, interventions, and other trial procedures.
- Able to ambulate at least 10 m independently with or without a walking aid.
- Being at risk of developing dementia:
- Mild Cognitive Impairment (MCI) Group. Diagnosis of Mild Cognitive Impairment, in accordance with the criteria used in the Comprehensive Assessment of Neurodegeneration and Dementia (COMPASS-ND) study2 (Table 1).
- Subjective Cognitive Impairment (SCI) Group. Diagnosis of Subjective Cognitive Impairment, in accordance with the COMPASS-ND study2 definition (Table 1).
- Cognitively Intact with Risk Factors Group. Cognitively Intact based on COMPASS ND study2 definition (Table 1)) AND have a history of two or more risk factors for dementia, defined as the following (Table 1):
- Obesity: Defined as a Body Mass Index (BMI) \> 30 kg/m2 (as derived from the National Institute of Health BMI calculator52)
- Hypertension: Defined as a documented Systolic Blood Pressure \> 140 mm Hg, OR a physician's diagnosis of hypertension, OR presence of physician prescribed medical treatment for hypertension, OR other approaches to treatment for hypertension (i.e., diet or exercise).
- Diabetes: Defined as a physician's diagnosis of diabetes, OR presence of physician prescribed medical treatment for diabetes, OR other approaches to treatment for diabetes (i.e., diet or exercise).
- +8 more criteria
You may not qualify if:
- A diagnosis of dementia
- Participants living in Nursing Homes or Adult Residential Facilities (Special Care Homes) will be excluded.
- Serious underlying disease, which, in the opinion of the study physician excludes engagement in interventions or may interfere with the participant's ability to participate fully in the study.
- Has had surgery within the last two months or has planned surgery in the coming 12 months that, deemed by the study physician, could interfere with the participant's vision, hearing, mobility or any other ability to participate in the study.
- Has a history of intracranial surgery.
- Regular Benzodiazepine use by a participant that the study physician determines to be significant enough to interfere with the participants ability to participate in the assessments and interventions in the study will be excluded.
- Presence of major depression, schizophrenia, severe anxiety or drug/alcohol abuse, or other medical illness that would prohibit them from safely participating in the study or may cause harm to the participant.
- Current Parkinsonism or any neurological disorder with residual motor deficits (e.g. stroke with motor deficit), active musculoskeletal disorders (e.g. severe osteoarthritis of lower limbs), or history of knee/hip replacement affecting gait performance during the baseline assessment.
- Severe visual and/or auditory impairment, which, according to the vision and hearing assessment, precludes the participant from engaging in the trial.
- Intention to enroll in other clinical trials during the same time period.
- Active participation in an organized and planned exercise program involving aerobic exercise and/or resistance training regimen in the previous 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of New Brunswicklead
- Horizon Health Networkcollaborator
- Réseau de Santé Vitalité Health Networkcollaborator
- Universite de Monctoncollaborator
- Western University, Canadacollaborator
Study Sites (1)
The University of New Brunswick
Fredericton, New Brunswick, E3B 5A2, Canada
Related Publications (3)
Omar H, Yetman L, Tranchant CC, Gallibois M, Hache JC, Faig K, Handrigan G, McGibbon C, Jarrett P. "It's About Connections": A Grounded Theory of Older Adults' Engagement in Remotely Delivered Home-Based Physical and Cognitive Exercise Interventions Aiming to Reduce the Risk of Dementia. J Patient Exp. 2025 Oct 30;12:23743735251392324. doi: 10.1177/23743735251392324. eCollection 2025.
PMID: 41180905DERIVEDDrahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
PMID: 39360568DERIVEDMcGibbon C, Jarrett P, Handrigan G, Bouchard D, Tranchant CC, Sexton AM, Yetman L, Robinson B, Crapoulet S, Chamard-Witkowski L, Liu-Ambrose T, Middleton LE, Almeida QJ, Bherer L, Lim A, Speechley M, Kamkar N, Montero Odasso M; Canadian Consortium on Neurodegeneration in Aging (CCNA), CAN-THUMBS UP Group. Protocol for SYNchronising Exercises, Remedies in GaIt and Cognition at Home (SYNERGIC@Home): feasibility of a home-based double-blind randomised controlled trial to improve gait and cognition in individuals at risk for dementia. BMJ Open. 2022 Mar 31;12(3):e059988. doi: 10.1136/bmjopen-2021-059988.
PMID: 35361653DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris McGibbon, PhD
University of New Brunswick
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 1, 2021
First Posted
August 10, 2021
Study Start
July 28, 2021
Primary Completion
March 8, 2023
Study Completion
July 27, 2023
Last Updated
October 2, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 12 months after the principal paper answering primary research questions are published.
- Access Criteria
- Qualified persons may request access via email to the Canadian Consortium for Neurodegeneration and Aging \[ccna.admin@ladydavis.ca\].
Deidentified IPD will be stored on a secure server called LORIS (Longitudinal Online Research and Imaging System) at the McGill Centre for Integrative Neuroscience, McGill University, Montreal, Quebec.