Sedentary BehaviorNCT04323423
The DURATION Study: reDUcing sedentaRy behAviour to Maintain cogniTIve functiON.
A study testing interrupting sedentary behaviour with light physical activity in people with Sedentary Behavior and Mild Cognitive Impairment, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sedentary Behavior, Mild Cognitive Impairment, Glucose Intolerance
- What is being tested?
- interrupting sedentary behaviour with light physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Optimal Reduction in Sedentary Behaviour to Reduce Glycemic Variability and Maintain Cognition: a Randomized Control Trial
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.
Read more
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.
Read the detailed description
This study will be a randomized crossover trial and reported in accordance with CONSORT guidelines. The study will involve a total of three seven-day conditions (2 experimental and 1 control) with a three-week washout period in-between to minimize practice effects for a total intervention period of nine weeks (see figure 1). Each condition will consist of one day supervised in the laboratory followed by six at-home days, following lab protocol as closely as possible.
Participants will be referred to the study by their physician. Interested participants will be asked to contact the researcher by email or phone call. Interested Participants will be invited into the lab for a familiarization session. They will be instructed to avoid caffeine, alcohol and MVPA for 48 hours prior to this session. During this session the following information will be obtained;
- Written informed consent
- Height using a stadiometer and weight using a standard beam scale
- Demographics questionnaire (education, ethnicity, family background, comorbidities)
- Physical Activity Readiness Questionnaire (PARQ+) (Bredin, Gledhill, Jamnik, \& Warburton, 2013)
- Resting blood pressure- will be measured once on each arm and then twice on the left arm with an automated BP monitor The participants will be educated/familiarized on the following;
- Cognitive assessments - Cambridge Neuropsychological Test Automated Battery (CANTAB)
- Fitting with an inclinometer (activPAL4)
Participants will be visited at their home ~72hrs prior to each condition to be fitted with the CGM and ActivPal. They will also be instructed to avoid caffeine, alcohol and MVPA for 48 hours prior to each of the three conditions. Dinner will be consumed between 7:00 and 9:00 pm, allowing for a 10 hour fast prior to the experimental condition the next morning. All participants will be instructed to arrive at the laboratory (with minimal activity during commute) at approximately 7:00 am. Upon arrival, participants will be asked to use the washroom and then rest for 30 minutes preceding a blood pressure measurement and first cognitive assessment. The participants will undergo the CANTAB cognitive assessments (at ~7:30 am) before meal consumption. A standardized breakfast meal will be consumed at 8:00 am, followed by lunch at 12:00 pm and dinner at 5:00 pm. Participants will be allotted 20 minutes for full meal consumption. The CANTAB cognitive assessments will then be re-administered at approximately 7:30 pm. Participants will be supervised throughout the conditions to ensure adherence to the protocols and will be permitted to watch DVDs, read books, magazines, newspapers, talk and/or work on a laptop computer. However, what they do during the first condition will be documented and then replicated for the remaining experimental conditions. Intensity of the bout intervals will be kept to an RPE of 6-9 using the Borg RPE scale.
Once the 12- hour laboratory component is complete, participants will be sent home (still wearing the CGM and activPAL) with the intension of replicating the laboratory-based protocol after each meal in their own free-living environment. Participants will track their mealtimes by sending photos to the researcher before consumption during the 6 at home days. The researcher will then go to the participants house on the last day (day 7) of each condition to re-administer the CANTAB cognitive assessments and collect the CGM, and activPal. There will then be a 3-week washout period, followed by replication of protocol for the remaining two conditions.
- Conditions
- Sedentary Behavior, Mild Cognitive Impairment, Glucose Intolerance, Overweight and Obesity
- Being tested
- interrupting sedentary behaviour with light physical activity
- Keywords
- Sedentary Behaviour, Physical activity, Walking, Older adults, Cognition, Glycemic variability, Randomized controlled trial
- Medical subject headings
- Sedentary Behavior, Cognitive Dysfunction, Glucose Intolerance, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interrupting sedentary behaviour with light physical activityBehavioural
replacing sitting with light walking bouts at different frequencies/durations
| Study group | Role | What they receive |
|---|---|---|
| Control (CON) | No intervention | 1) Condition A (CON): This will be the control condition. It will consist of uninterrupted sitting from 8 am until 7 pm, only rising from the chair to void. |
| one 10 minute bout - (LONG) | Experimental | will consist of completing one 10-minute bout of light intensity walking (RPE 6-9) 30 minutes post-prandial. Participants will rise from their seated position to walk ~10 metres to a treadmill to perform this bout. The participant will repeat this after lunch and dinner, for an accumulated total of 30 minutes of light walking. Receives: Behavioral: interrupting sedentary behaviour with light physical activity |
| four 2.5 minute bouts SHORT | Experimental | will consist of interrupting sitting with four 2.5-minute bouts of light walking at 30 minutes, 60 minutes, 90 minutes and 120 minutes post-prandial. Participants will rise from their seated position to walk ~10 metres to a treadmill to perform these bouts. The participant will repeat this after breakfast, lunch and dinner for an accumulated total of 30 minutes of light walking. Receives: Behavioral: interrupting sedentary behaviour with light physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Variability
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.
Measured: 1-7 days
Secondary outcomes (1)
Cognition
CANTAB will be used to measure change in cognitive function. This is a computerized battery of neuropsychological tests utilizing touch sensitive screen technology that has been shown to be highly sensitive and a precise measure of cognitive function, correlated to neural networks (CANTAB, 2017). The following three cognitive domains were selected for testing; attention and psychomotor function (Motor Screening Task (MOT) and Rapid Visual Information Processing (RVP)), memory (Delayed Matching to Sample (DMS)) and executive function (Intra-Extra Dimensional Set Shift (IED))
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Why it stopped: Principal investigator moved to a different role
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- randomized crossover trial and reported in accordance with CONSORT guidelines. The study will involve a total of three seven-day conditions (2 experimental and 1 control) with a three-week washout period in-between to minimize practice effects for a total intervention period of nine weeks. Each condition will consist of one day supervised in the laboratory followed by six at-home days, following lab protocol as closely as possible.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Harry Prapavessis, Western University, Canada
- Investigators
- Harry Prapavessis, Ph.D, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323423
- Sponsor's protocol ID
- Glycemic variability & SB
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Optimal Reduction in Sedentary Behaviour to Reduce Glycemic Variability and Maintain Cognition: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04323423
- Acronym / sponsor ID
- Glycemic variability & SB
- Conditions
- Sedentary Behavior, Mild Cognitive Impairment, Glucose Intolerance, Overweight and Obesity
- Keywords
- Sedentary Behaviour, Physical activity, Walking, Older adults, Cognition, Glycemic variability, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator moved to a different role
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a randomized crossover trial and reported in accordance with CONSORT guidelines. The study will involve a total of three seven-day conditions (2 experimental and 1 control) with a three-week washout period in-between to minimize practice effects for a total intervention period of nine weeks (see figure 1). Each condition will consist of one day supervised in the laboratory followed by six at-home days, following lab protocol as closely as possible.
Participants will be referred to the study by their physician. Interested participants will be asked to contact the researcher by email or phone call. Interested Participants will be invited into the lab for a familiarization session. They will be instructed to avoid caffeine, alcohol and MVPA for 48 hours prior to this session. During this session the following information will be obtained;
- Written informed consent
- Height using a stadiometer and weight using a standard beam scale
- Demographics questionnaire (education, ethnicity, family background, comorbidities)
- Physical Activity Readiness Questionnaire (PARQ+) (Bredin, Gledhill, Jamnik, \& Warburton, 2013)
- Resting blood pressure- will be measured once on each arm and then twice on the left arm with an automated BP monitor The participants will be educated/familiarized on the following;
- Cognitive assessments - Cambridge Neuropsychological Test Automated Battery (CANTAB)
- Fitting with an inclinometer (activPAL4)
Participants will be visited at their home ~72hrs prior to each condition to be fitted with the CGM and ActivPal. They will also be instructed to avoid caffeine, alcohol and MVPA for 48 hours prior to each of the three conditions. Dinner will be consumed between 7:00 and 9:00 pm, allowing for a 10 hour fast prior to the experimental condition the next morning. All participants will be instructed to arrive at the laboratory (with minimal activity during commute) at approximately 7:00 am. Upon arrival, participants will be asked to use the washroom and then rest for 30 minutes preceding a blood pressure measurement and first cognitive assessment. The participants will undergo the CANTAB cognitive assessments (at ~7:30 am) before meal consumption. A standardized breakfast meal will be consumed at 8:00 am, followed by lunch at 12:00 pm and dinner at 5:00 pm. Participants will be allotted 20 minutes for full meal consumption. The CANTAB cognitive assessments will then be re-administered at approximately 7:30 pm. Participants will be supervised throughout the conditions to ensure adherence to the protocols and will be permitted to watch DVDs, read books, magazines, newspapers, talk and/or work on a laptop computer. However, what they do during the first condition will be documented and then replicated for the remaining experimental conditions. Intensity of the bout intervals will be kept to an RPE of 6-9 using the Borg RPE scale.
Once the 12- hour laboratory component is complete, participants will be sent home (still wearing the CGM and activPAL) with the intension of replicating the laboratory-based protocol after each meal in their own free-living environment. Participants will track their mealtimes by sending photos to the researcher before consumption during the 6 at home days. The researcher will then go to the participants house on the last day (day 7) of each condition to re-administer the CANTAB cognitive assessments and collect the CGM, and activPal. There will then be a 3-week washout period, followed by replication of protocol for the remaining two conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomized crossover trial and reported in accordance with CONSORT guidelines. The study will involve a total of three seven-day conditions (2 experimental and 1 control) with a three-week washout period in-between to minimize practice effects for a total intervention period of nine weeks. Each condition will consist of one day supervised in the laboratory followed by six at-home days, following lab protocol as closely as possible.
| Arm | Type | Receives |
|---|---|---|
| Control (CON) | No intervention | –1) Condition A (CON): This will be the control condition. It will consist of uninterrupted sitting from 8 am until 7 pm, only rising from the chair to void. |
| one 10 minute bout - (LONG) | Experimental | Behavioral: interrupting sedentary behaviour with light physical activitywill consist of completing one 10-minute bout of light intensity walking (RPE 6-9) 30 minutes post-prandial. Participants will rise from their seated position to walk ~10 metres to a treadmill to perform this bout. The participant will repeat this after lunch and dinner, for an accumulated total of 30 minutes of light walking. |
| four 2.5 minute bouts SHORT | Experimental | Behavioral: interrupting sedentary behaviour with light physical activitywill consist of interrupting sitting with four 2.5-minute bouts of light walking at 30 minutes, 60 minutes, 90 minutes and 120 minutes post-prandial. Participants will rise from their seated position to walk ~10 metres to a treadmill to perform these bouts. The participant will repeat this after breakfast, lunch and dinner for an accumulated total of 30 minutes of light walking. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| interrupting sedentary behaviour with light physical activityreplacing sitting with light walking bouts at different frequencies/durations | Behavioural | four 2.5 minute bouts SHORT, one 10 minute bout - (LONG) |
Primary outcome
Glycemic Variability
Time frame: 1-7 days
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.
1 secondary outcome
Cognition
Time frame: 1-7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
Related trials for Sedentary Behavior
Active, not recruiting
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Sedentary Behavior, Physical Inactivity
Recruiting
Behavioral Intervention and Guided Stepping Training Early Post-Stroke
Stroke
Not yet recruiting
Individual Variability in Energy Compensation After a 12-Week Supervised Exercise Intervention
Physical Inactivity, Overweight
Not yet recruiting
Effects of Different Amounts of Plyometric Exercise Without Jumping in Physically Inactive Older Adults
Sedentary Behavior / Physical Inactivity, Aging
Not yet recruiting
Changing Lifestyle to Improve Quality of Life in Spanish Adolescents With Asthma
Asthma (Diagnosis)
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.
Harry Prapavessis, Ph.D principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interrupting sedentary behaviour with light physical activity in people with Sedentary Behavior and Mild Cognitive Impairment, run by Western University, Canada at 1 site 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 6 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: withdrawn, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Glycemic Variability (time frame: 1-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2024.