An interventional study of Resistance Training and Balance and Tone Training in Cognitive Impairment, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Western University, Canada · Not applicable, Interventional, and Treatment
Among 223 studies in Cognitive Dysfunction with a site in Canada — 60 open to participants now, 79 under way, 7 of them phase 3. Cognitive Dysfunction · Canada.
Among the 223 studies in Cognitive Dysfunction with a site in Canada, this one is the 135th largest by enrollment of the 170 interventional ones that give a count, is one of 14 that started in 2017, is one of 115 with no phase, and was the 73rd registered.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
Browse Cognitive Dysfunction studies →60 of the 223 studies in Cognitive Dysfunction with a site in Canada are open now. Recruiting first, the newest first:
Posit Science Corporation · Sites in Canada
Laval University · Sites in Canada
Qanatpharma AG · Sites in Canada
University of British Columbia · Sites in Canada
Ottawa Hospital Research Institute · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 60 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
223 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 29 · Phase 3 21 · Phase 4 3
First in 1999; this study’s year is marked. 14 started in 2017.
This study's enrollment of 24 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Median enrollment 62 across the 170 interventional studies, 353 across the 52 observational. Of the 121 that completed or were terminated, 17 (14%) have results posted.
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38 of 223 have an industry lead sponsor. The 10 most frequent:
Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.
Western University, Canada has 6 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
24 of the studies in Cognitive Dysfunction with a site in Canada that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT05230758Phase 3Donald MabbottEffect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour | 2027-11-30 |
| NCT06529744University Health Network, TorontoImproving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling | 2026-11 |
| NCT04335994Sunnybrook Health Sciences CentreENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing | 2026-12 |
| NCT06783283Centre for Addiction and Mental HealthTACS to Engage Theta-Gamma Coupling and Enhance Working Memory in Patients With MCI (tACS-MCI) | 2026-12 |
Among the 223 studies in Cognitive Dysfunction with a site in Canada, from their registry updates:
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Older adults with type 2 diabetes experience cognitive decline and are at higher risk for developing dementia. Consequently, older adults at-risk for developing type 2 diabetes (based on body mass, glucose levels) are at higher risk for cognitive decline, and intervening at this point may prevent or delay the onset of such decline. One promising lifestyle intervention that has been shown to improve cognitive function in other populations is exercise. However, before investigators can examine whether exercise will improve cognitive function and brain health (structure and function) in this at-risk population, a feasibility pilot study is needed to determine whether a larger-scale trial would be viable.
Investigators will conduct a six-month randomized control trial (RCT) exercise intervention. Thirty older adults (aged 60-80) at-risk for diabetes will be randomly assigned into one of two groups: 1) Resistance training, or 2) Balance and Tone training (control). All participants will engage in three one-hour exercise classes per week. Once a month, a neutral assessor will visit the classes to evaluate the quality of the classes for participants. Assessments will be made at baseline, midpoint (three months) and trial completion (six months), and will include cognitive testing, health questionnaires, physical testing, and magnetic resonance imaging (MRI; to assess structural and functional brain changes). Throughout the study, investigators will examine data for trends in successful recruitment strategies and rates of recruitment and adherence to inform future clinical trials in this population. Research assistants (n = 30) in the study will complete an anonymous feedback survey upon completion of their volunteer term, to assist in improving the study for future participants and volunteers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use programmable weight machines along with free weights to target primary muscle groups. In addition, they will complete mini-squats, mini-lunges, and lunge walks. Participants will complete two sets of 6-8 reps. Training stimulus will be increased using the 7RM method - when 2 sets of 6-8 reps are completed with proper form and without discomfort. Investigators will record the number of sets completed and the load lifted for each exercise for each participant at every class.
Behavioral: Resistance Training
Exercises will include stretching exercises, range of motion exercises, basic core-strength exercises, balance exercises, and relaxation techniques. Only bodyweight will be applied (i.e., no additional loading). This group controls for confounding variables such as physical training received by traveling to the training centres, social interaction, and changes in lifestyle secondary to study participation.
Behavioral: Balance and Tone Training
Six months of thrice-weekly resistance training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down). Classes will be group classes, with up to five participants in each.
Six months of thrice-weekly stretching and relaxation exercises. Each session will be 60 minutes. Classes will be group classes, with up to five participants in each.
Number of participants recruited after 12 months
Time frame: 12 months
Number of exercise classes attended at trial completion (6 months)
Time frame: 6 months
Change in cognitive function as measured by Alzheimer's Disease Assessment Scale - Cog - Plus (ADAS-Cog-Plus)
Time frame: Baseline, 3 months, and 6 months
Change in hippocampal volume as measured via high resolution T1 images collected during MRI scanning in both 3T and 7T machines.
Time frame: Baseline and 6 months
Change in hippocampal functional activation as measured during performance on associative memory task during fMRI scanning
For this task, participants will be asked to encode and then recall items (face or places) and items in conjunction (faces matched with places)
Time frame: Baseline and 6 months
Change in memory as measured by performance on associative memory task
Time frame: Baseline, 3 months, and 6 months
Change in executive functions as measured by Stroop Test
Time frame: Baseline, 3 months, and 6 months
Change in aerobic fitness as measured by six minute walk test
Time frame: Baseline, 3 months, and 6 months
Change in mobility and balance as measured by Short Physical Performance Battery
Time frame: Baseline, 3 months, and 6 months
Change in muscle strength as measured by one-repetition maximum test
Time frame: Baseline, 3 months, and 6 months
Change in blood glucose levels as measured by finger prick glucose test
Time frame: Baseline, 3 months, and 6 months
Plan to share: No
Ran from Nov 2017 to primary completion in Oct 2019, 23 months.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 23 months is below that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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