Mild Cognitive ImpairmentNCT04507386
Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study
A study testing Take a STAND for health in people with Mild Cognitive Impairment, run by University of Sao Paulo.
Trial summary
This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in patients with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Take a STAND for health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Aug 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Middle-aged and older adults with mild cognitive impairment confirmed by a team of neurologists from the CEREDIC HC-FMUSP
Who cannot join
- Patients who spend less than 8 hours per day in sedentary time
- Patients who are physically active (more than 150 min/week of moderate physical activity, or more than 75 min/week of vigorous activity)
- Patients who are functional illiterates
- Patients with history or clinical diagnosis of neurological diseases
- Patients with severe psychiatric symptoms
- Patients taking antidepressants
- Patients with visual and/or hearing impairments that prevent participation
About this study
Official title: Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study TS4H-MCI
This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in patients with mild cognitive impairment. A 4-month parallel-group randomized controlled trial will be conducted aiming to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity in patients with mild cognitive impairment. Additionally, a sub-sample of patients will complete a randomised cross-over study aiming to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Take a STAND for health
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take a STAND for healthBehavioural
The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior
| Study group | Role | What they receive |
|---|---|---|
| Take a STAND for health | Experimental | A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity Receives: Behavioral: Take a STAND for health |
| Control | No intervention | The control group will receive regular medical care and advice on healthy lifestyle, including physical activity and healthy eating recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary behaviour assessed by ActivPAL™
Measured: 4 months
Secondary outcomes (25)
Physical activity levels assessed by ActiGraph GT3X®
Measured: 4 months
Cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)
Questionnaire to be completed by the patient. Final score 0 to 30, lower scores indicate worse cognitive performance
Measured: 4 months
Cognitive decline assessed by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Questionnaire to be completed by the caregiver. 26 Likert scale questions. Higher scores indicate worse cognitive performance
Measured: 4 months
Subjective memory complaints assessed by the Memory Complaint Scale (MCS)
Questionnaire to be completed by the patient and the caregiver. Final scores classify memory complaints as absent, mild, moderate or accentuated
Measured: 4 months
Functional impairments in activities of daily living assessed by the Functional Activities Questionnaire (FAQ)
Questionnaire to be completed by the caregiver. Final score 0 to 30, higher scores indicate greater functional dependency
Measured: 4 months
Anxiety symptoms assessed by the Geriatric Anxiety Inventory (GAI)
Questionnaire to be completed by the patient. Final score 0 to 20, higher scores indicate greater anxiety symptoms
Measured: 4 months
Depression symptoms assessed by the Geriatric Depression Scale (GDS-15)
Questionnaire to be completed by the patient. Final score 0 to 15, higher scores indicate greater depression symptoms
Measured: 4 months
Neurocognitive assessment assessed by the Cogstate Research™ (Cogstate, Melbourne, AUS)
Reliable online system that assesses verbal learning capacity, executive function, processing speed, attention capacity, reaction time, and operational memory. Final score will be generated automatically by the system
Measured: 4 months
Magnetic resonance imaging using the Philips ACHIEVA 3.0 Tesla
The following sequences will be obtained: 1 - sagittal 3D T1; 2 - axial T2 fast spin echo (FSE); 3 - axial fluid-attenuated inversion recovery (FLAIR); 4 - coronal T2 spectral presaturation with inversion recovery (SPIR); 5 - coronal T2 aligned with hippocampus; 6 - SENSE diffusion
Measured: 4 months
Positron emission computed tomography with 18F-fluordesoxyglucose (PET-18FDG) using the Biograph, CTI/Siemens, Knowville, EUA
Tomographic sections will be acquired for 15 minutes with a 256x256 matrix, zoom 2.5, resulting in pixels of size 1.04 mm (voxel of 1.04 mm3). The images will be reconstructed using the ordered subset expectation maximization (OSEM) iterative method, with six iterations and 16 subsets, and smoothed with a 5 mm Gaussian filter. The data will be corrected for scattering, attenuation and decay
Measured: 4 months
Assessment of cerebrovascular reactivity to CO2 inhalation
Patients will wear a mask connected to a unidirectional valve with a Douglas bag (with 5% CO2). Evaluations will include: partial pressure of carbon dioxide at the end of expiration (PetO2, PetCO2) (Metalyzer model III b/breath-by-breath, CORTEX, Germany) and O2 saturation (SpO2; Nellcor, Medtronic Corporation, USA). Blood flow and diameter of the internal carotid artery will be assessed using a Doppler ultrasound (Logiq E, General Electric, Milwaukee, USA) connected to a linear transducer (12L-RS - 5.0-13.0 MHz). Cerebrovascular reactivity will be assessed by responses of arterial diameter, blood flow and shear rate to CO2 inhalation (reactivity = peak - baseline). A software with automatic detection of the artery walls will be used (Cardiovascular Suite, Quipu®, Pisa, Italy). Blood flow will be calculated (Flow = Vm x πr2 x 60). The shear rate will be calculated using the following formula: Shear rate = 8 x Vm / diameter
Measured: 4 months
Muscle functional assessed by the Timed Stands Test and the Timed Up-and-Go Test
Test results will be combined to report muscle function
Measured: 4 months
Handgrip strength assessed by a hand dynamometer
Patient will have three 5-second trials, with 1-minute interval between trials. Best score will be considered handgrip strength
Measured: 4 months
Blood pressure
Measured: 4 months
Fatigue severity assessed by the Fatigue Severity Scale (FSS)
Measured: 4 months
Physical and mental aspects of fatigue assessed by the Chalder Fatigue Scale (CFS)
Measured: 4 months
Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Measured: 4 months
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Measured: 4 months
Quality of life assessed by the SF-36 (Medical Outcomes Study 36 - Short-Form Health Survey)
Measured: 4 months
Food consumption
24-hour dietary recalls
Measured: 4 months
Insulin sensitivity
Fasting serum concentrations of glucose, insulin
Measured: 4 months
Lipid profile
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Measured: 4 months
Inflammatory cytokines
pro- and anti-inflammatory cytokines: IL-1, IL-1ra, IL-6, IL-10 e TNF-alpha
Measured: 4 months
Genetic profile for Alzheimer's disease
Genotyping of apolipoprotein E (ApoE)
Measured: 4 months
Oral glucose tolerance test
Fasting, 30, 60, 90, and 120 minutes
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- A 4-month parallel-group randomised controlled trial will be performed, in which patients with mild cognitive impairment will be assessed at baseline (PRE) and after 4 months (POST). Moreover, a sub-sample of patients will perform a randomised crossover trial at baseline (PRE). Patients will complete three experimental sessions in a random manner, as follows: Prolonged sitting (SIT), in which participants engaged in prolonged sitting throughout an 5-h period and were instructed to minimize excessive movement; Exercise followed by prolonged sitting (EX), in which participants performed a 30-min moderate-to-vigorous exercise bout on a treadmill, subsequently, participants engaged in prolonged sitting as described for SIT; Light-intensity breaks (BR), in which participants completed a 3-min bout of light-intensity walking every 30 min of sitting throughout the experimental period.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507386
- Sponsor's protocol ID
- Take a STAND for Health MCI
- Status last verified
- Aug 2020
- First submitted
- 30 Jul 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study TS4H-MCI
- ClinicalTrials.gov ID
- NCT04507386
- Acronym / sponsor ID
- Take a STAND for Health MCI
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 11 Aug 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.
This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in patients with mild cognitive impairment. A 4-month parallel-group randomized controlled trial will be conducted aiming to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity in patients with mild cognitive impairment. Additionally, a sub-sample of patients will complete a randomised cross-over study aiming to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 4-month parallel-group randomised controlled trial will be performed, in which patients with mild cognitive impairment will be assessed at baseline (PRE) and after 4 months (POST). Moreover, a sub-sample of patients will perform a randomised crossover trial at baseline (PRE). Patients will complete three experimental sessions in a random manner, as follows: Prolonged sitting (SIT), in which participants engaged in prolonged sitting throughout an 5-h period and were instructed to minimize excessive movement; Exercise followed by prolonged sitting (EX), in which participants performed a 30-min moderate-to-vigorous exercise bout on a treadmill, subsequently, participants engaged in prolonged sitting as described for SIT; Light-intensity breaks (BR), in which participants completed a 3-min bout of light-intensity walking every 30 min of sitting throughout the experimental period.
| Arm | Type | Receives |
|---|---|---|
| Take a STAND for health | Experimental | Behavioral: Take a STAND for healthA newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity |
| Control | No intervention | –The control group will receive regular medical care and advice on healthy lifestyle, including physical activity and healthy eating recommendations |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Middle-aged and older adults with mild cognitive impairment confirmed by a team of neurologists from the CEREDIC HC-FMUSP
Key exclusion criteria (7 listed)
- Patients who spend less than 8 hours per day in sedentary time
- Patients who are physically active (more than 150 min/week of moderate physical activity, or more than 75 min/week of vigorous activity)
- Patients who are functional illiterates
- Patients with history or clinical diagnosis of neurological diseases
- Patients with severe psychiatric symptoms
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 |
|---|---|---|
| Take a STAND for healthThe Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior | Behavioural | Take a STAND for health |
Primary outcome
Sedentary behaviour assessed by ActivPAL™
Time frame: 4 months
25 secondary outcomes
Physical activity levels assessed by ActiGraph GT3X®
Time frame: 4 months
Cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: 4 months
Cognitive decline assessed by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Time frame: 4 months
Subjective memory complaints assessed by the Memory Complaint Scale (MCS)
Time frame: 4 months
Functional impairments in activities of daily living assessed by the Functional Activities Questionnaire (FAQ)
Time frame: 4 months
Anxiety symptoms assessed by the Geriatric Anxiety Inventory (GAI)
Time frame: 4 months
Depression symptoms assessed by the Geriatric Depression Scale (GDS-15)
Time frame: 4 months
Neurocognitive assessment assessed by the Cogstate Research™ (Cogstate, Melbourne, AUS)
Time frame: 4 months
Magnetic resonance imaging using the Philips ACHIEVA 3.0 Tesla
Time frame: 4 months
Positron emission computed tomography with 18F-fluordesoxyglucose (PET-18FDG) using the Biograph, CTI/Siemens, Knowville, EUA
Time frame: 4 months
Assessment of cerebrovascular reactivity to CO2 inhalation
Time frame: 4 months
Muscle functional assessed by the Timed Stands Test and the Timed Up-and-Go Test
Time frame: 4 months
Handgrip strength assessed by a hand dynamometer
Time frame: 4 months
Blood pressure
Time frame: 4 months
Fatigue severity assessed by the Fatigue Severity Scale (FSS)
Time frame: 4 months
Physical and mental aspects of fatigue assessed by the Chalder Fatigue Scale (CFS)
Time frame: 4 months
Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 months
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time frame: 4 months
Quality of life assessed by the SF-36 (Medical Outcomes Study 36 - Short-Form Health Survey)
Time frame: 4 months
Food consumption
Time frame: 4 months
Insulin sensitivity
Time frame: 4 months
Lipid profile
Time frame: 4 months
Inflammatory cytokines
Time frame: 4 months
Genetic profile for Alzheimer's disease
Time frame: 4 months
Oral glucose tolerance test
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Take a STAND for health in people with Mild Cognitive Impairment, run by University of Sao Paulo.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Sedentary behaviour assessed by ActivPAL™ (time frame: 4 months). 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 17 Aug 2020.