The DURATION Study: reDUcing sedentaRy behAviour to Maintain cogniTIve functiON. (NCT04323423) | Clinical Trial Compass
WithdrawnNot Applicable
The DURATION Study: reDUcing sedentaRy behAviour to Maintain cogniTIve functiON.
Stopped: Principal investigator moved to a different role
Canada0Started 2025-12-01
Plain-language summary
Rationale: Older adults spend the majority of their time in sedentary behaviours (SB). High amounts of SB have been correlated with reduced cognitive performance. Long periods of time spent sitting results in excessive glycemic variability, potentially contributing to cognitive decline. Reducing/replacing SB with short intermittent bouts of light physical activity have shown positive effects on glycemic variability. Thus, interrupting prolonged sitting with bouts of light physical activity may regulate blood glucose and thus mitigate cognitive decline.
Purpose: This study intends to investigate the appropriate interval frequency of post-prandial SB reduction, by light physical activity needed to optimize total and incremental area under the curve for glucose response in overweight older adults at risk for glucose intolerance with mild cognitive impairment in both lab and free-living environments. Second, this study aims to investigate the acute impact of reducing SB on glycemic variability and its relationship with cognition.
Hypothesis: First, there will be a dose-dependent response of more frequent interruptions of SB (more frequent intervals of light physical activity) with better glycemic control. Second, reducing SB will result in less glycemic variability, which will translate into better levels of cognitive performance.
Methods: Generalized linear mixed models with random intercepts will be used to evaluate the differential effects of the experimental conditions on the selected outcomes.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 65 years
* Have a caregiver that works with you at least 20 hours a week (needs to be present for the familiarization session (explained below) and drop-off and pick-up from lab sessions)
* Diagnosis of diabetes by a healthcare provider (e.g. family doctor).
* Diagnosis of MCI by a healthcare provider
* Self-report being physically inactive (not meeting the current PA guidelines of 150 min MVPA/week)
* Self-report being sedentary- (defined as self-reported sedentary time ≥ 7 h/day)
* Able to walk one block without an assistive device
* Own a smartphone with unlimited outgoing text messages and access to internet connection. The smartphone must be either iphone 7 (with iOS of 12.2 or higher) or Android operating system 5 or higher to allow for Libre View mobile application compatibility.
* Able to read, write and understand English
Exclusion Criteria:
* Currently smoke
* Depression (Geriatric Depression Score short-form \> 6 (GDS)) (Yesavage, Brink, Rose, \& et al, 1983).
* Medication: hypoglycemics; antilipidemics; antidepressants; beta blockers; anti-anxiety agents
* Peri-menopausal or menopausal women (must be post-menopausal)
* Excessive alcohol consumption (\> 8 points on the Alcohol Use Disorders Identification Test)
* Uncontrolled hypertension (measured systolic \> 140 mmHg or diastolic \> 90 mmHg)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.