Diabetes Mellitus, Type 2DIASCOPNCT04915339
Pilot Study Among Type 2 Diabetes Patients Investigating the Effects of Computerized Cognitive and Physical Activity Programs Combined or Single (DIASCOP)
A study testing Physical activity, cognitive training and combined physical and cognitive training in people with Diabetes Mellitus, Type 2, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The purpose of this study is to assess the cognitive benefits of combined physical activity and cognitive training on cognitive health compare to physical activity or cognitive training programs singly administrated among type 2 diabetes. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Physical activity, cognitive training and combined physical and cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2021to Jun 2023
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 50 and 70 years old, suffering from type 2 diabetes.
- Normal or corrected sight and audition. Being able to engage in physical activity. Being able to give enlightened consent. Being affiliate to social welfare
Who cannot join
- Being unable to meet the study conditions or to answer in French to surveys. Any condition considered, by the investigator, as incompatible with the participation in the study.
- Major incapacities. Refusal of participation.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Frédéric Dutheil
About this study
Official title: Pilot Study Among Type 2 Diabetes Patients Investigating Effects of Computerized Cognitive and Physical Activity Programs Combined or Single.
The purpose of this study is to assess the cognitive benefits of combined physical activity and cognitive training on cognitive health compare to physical activity or cognitive training programs singly administrated among type 2 diabetes. Two group in cross over will take part in either physical activity only (for the first one) or cognitive training only (for the second one) for one month then the other way around during the second month. A fallow up will be administrated 3 months later.
Read the detailed description
The growing Type 2 diabetes prevalence is associated with health, economic and social consequences. As such, type 2 diabetes is recognized as major health issue. Health care should go on after being discharged from the hospital in order to promote cognitive autonomy. Physical activity and cognitive training are two interventions often recommended individually to benefit cognition among type 2 diabetes patients. Yet, a program combining physical activity and cognitive training might be more effective to favor cognitive health.
In this study, diabetes patient between 50 and 75 years old will be allocated randomly in 3 intervention groups in order to have a homogeneous distribution of the education level, sex and age across the 3 samples. The first group will take part in a physical activity program the first month and in a cognitive training one the second. The second group will be cross-over meaning taking part in a cognitive training program the first month and engaging in the physical activity one the second month. The last group will engage in a program based on resonance frequency breathing the first month (as a control condition), then in a combined physical activity and cognitive training program. Between the 2 interventions, there will be a 15 days break (limiting the transfer of the effect of one intervention onto another). At the beginning of the study, a screening will allow to identify possible exclusion criteria (health factors that could influence the main outcomes). At the beginning (baseline) of the first intervention and after each month, neuropsychological tests assessing cognitive and psychological health as well as well-being. Physiological parameters such as heart rate variability, cortisol and DHEA levels, muscle and lean mass, blood circulation (assessed by Laser speckle contrast imaging). A whole session (psychological and physiological testing) should take 1 h 30. Besides, participants will complete online questionnaires. They have one week after the testing to complete those surveys. If they are late an email will be sent before a phone call in the case the delay goes on.
The main outcome is the increase of the cognitive variables after the intervention. It is expected that the physical activity and cognitive training combined program will benefit cognitive functioning more than either of those programs administrated individually. To investigate to long-term effects of the intervention, a fallow up 3 months later will be conduct
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Physical activity, cognitive training, combined physical and cognitive training
- Keywords
- Exercise, Physical fitness, Neuropsychological Tests, Cognition, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
The intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables…) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation…).
cognitive trainingBehavioural
The intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables…) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation…).
combined physical and cognitive trainingBehavioural
The intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables…) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation…).
| Study group | Role | What they receive |
|---|---|---|
| Group 1: physical activity then cognitive training | Experimental | Using an online-computerized application, physical activities will be prescribed for one month. After a 15 days break, cognitive training activities will be prescribed the same way. A feedback by the patient will be asked fallowing each activity to control the observance. Receives: Behavioral: Physical activity; Behavioral: cognitive training |
| Group 2: Cognitive training then physical activity | Experimental | Contrary to the first group, the second one starts with cognitive training intervention then engages in physical activity in same way as the first group. A feedback by the patient will also be asked fallowing each activity to control the observance Receives: Behavioral: Physical activity; Behavioral: cognitive training |
| Group 3 : resonance frequency breathing then combined physical activity and cognitive training | Experimental | The third group takes part in a 1 month breathing exercise program. After a 15 days break (as the groups 1 and 2), a combined physical activity and cognitive training program is administrated for 1 month. As the others arms, a feedback by the patient will be asked fallowing each activity to control the observance Receives: Behavioral: combined physical and cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic memory performances
Scores are obtained from delayed memory recall tests from the logical memory subtest of the Wechsler memory scale. It consists of two short narrative stories with an immediate recall phase after each story and a delayed recall phase after 10 minutes. During the delayed recall, each correct detail was awarded with one score point. On a scale of 0 to 50, a higher score means a better detailed recall.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Episodic memory performances
Scores are obtained from delayed memory recall tests from the logical memory subtest of the Wechsler memory scale. It consists of two short narrative stories with an immediate recall phase after each story and a delayed recall phase after 10 minutes. During the delayed recall, each correct detail was awarded with one score point. On a scale of 0 to 50, a higher score means a better detailed recall.
Measured: Month 2 (a week after the second intervention)
Episodic memory performances
Scores are obtained from delayed memory recall tests from the logical memory subtest of the Wechsler memory scale. It consists of two short narrative stories with an immediate recall phase after each story and a delayed recall phase after 10 minutes. During the delayed recall, each correct detail was awarded with one score point. On a scale of 0 to 50, a higher score means a better detailed recall.
Measured: Month 3
Secondary outcomes (39)
Heart rate variability
Time interval between two heart beats assessed by a monitoring watch (Empatica E4) and belt (Zephyr Bioharness 3)
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Heart rate variability
Time interval between two heart beats assessed by a monitoring watch (Empatica E4) and belt (Zephyr Bioharness 3)
Measured: Month 2 (a week after the second intervention)
Heart rate variability
Time interval between two heart beats assessed by a monitoring watch (Empatica E4) and belt (Zephyr Bioharness 3)
Measured: Month 3
Blood circulation
Assessed by laser speckle contrast imaging (LSCI).
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Blood circulation
Assessed by laser speckle contrast imaging (LSCI).
Measured: Month 2 (a week after the second intervention)
Blood circulation
Assessed by laser speckle contrast imaging (LSCI).
Measured: Month 3
Biomarkers of stress
A salivary sample to test cortisol level and DHEA.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Biomarkers of stress
A salivary sample to test cortisol level and DHEA.
Measured: Month 2 (a week after the second intervention)
Biomarkers of stress
A salivary sample to test cortisol level and DHEA.
Measured: Month 3
Body Mass index
The ratio between weight and height will be computed to report BMI in kg/m2.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Body Mass index
The ratio between weight and height will be computed to report BMI in kg/m2.
Measured: Month 2 (a week after the second intervention)
Body Mass index
The ratio between weight and height will be computed to report BMI in kg/m2.
Measured: Month 3
Life satisfaction scale
This scale assesses the feeling of satisfaction of one's life. This scale has 5 items. The minimum score is 5 and the maximum score is 35. A higher score means a higher life satisfaction level.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Life satisfaction scale
This scale assesses the feeling of satisfaction of one's life. This scale has 5 items. The minimum score is 5 and the maximum score is 35. A higher score means a higher life satisfaction level.
Measured: Month 2 (a week after the second intervention)
Life satisfaction scale
This scale assesses the feeling of satisfaction of one's life. This scale has 5 items. The minimum score is 5 and the maximum score is 35. A higher score means a higher life satisfaction level.
Measured: Month 3
Psychological Outcome Profiles
This survey assesses the patient's satisfaction level before and after the intervention. Five items with a 6-points Likert scale (0 to 5) allow to obtain a score between 0 and 25. A higher score means a better satisfaction level
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Psychological Outcome Profiles
This survey assesses the patient's satisfaction level before and after the intervention. Five items with a 6-points Likert scale (0 to 5) allow to obtain a score between 0 and 25. A higher score means a better satisfaction level
Measured: Month 2 (a week after the second intervention)
Psychological Outcome Profiles
This survey assesses the patient's satisfaction level before and after the intervention. Five items with a 6-points Likert scale (0 to 5) allow to obtain a score between 0 and 25. A higher score means a better satisfaction level
Measured: Month 3
Interoception awareness questionnaire
To assess the awareness of both neutral and negative bodily signals, this scale has 19 items with a 5-points Likert scale (1 to 5). The minimum total score is 9 while the maximum is 95. A higher score means a higher perception of bodily signals.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Interoception awareness questionnaire
To assess the awareness of both neutral and negative bodily signals, this scale has 19 items with a 5-points Likert scale (1 to 5). The minimum total score is 9 while the maximum is 95. A higher score means a higher perception of bodily signals.
Measured: Month 2 (a week after the second intervention)
Interoception awareness questionnaire
To assess the awareness of both neutral and negative bodily signals, this scale has 19 items with a 5-points Likert scale (1 to 5). The minimum total score is 9 while the maximum is 95. A higher score means a higher perception of bodily signals.
Measured: Month 3
BORB Birmingham Object Recognition Battery
To assess visuospatial processing by asking the participants if two stimuli are orientated the same way.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
BORB Birmingham Object Recognition Battery
To assess visuospatial processing by asking the participants if two stimuli are orientated the same way.
Measured: Month 2 (a week after the second intervention)
BORB Birmingham Object Recognition Battery
To assess visuospatial processing by asking the participants if two stimuli are orientated the same way.
Measured: Month 3
Executive functions
A battery of 5 tests assessing cognitive inhibition (Stroop and Go/No-Go), cognitive flexibility (Trail Making Test), working memory (Nback) and lexical access (verbal fluency) to reflect executive functioning.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Executive functions
A battery of 5 tests assessing cognitive inhibition (Stroop and Go/No-Go), cognitive flexibility (Trail Making Test), working memory (Nback) and lexical access (verbal fluency) to reflect executive functioning.
Measured: Month 2 (a week after the second intervention)
Executive functions
A battery of 5 tests assessing cognitive inhibition (Stroop and Go/No-Go), cognitive flexibility (Trail Making Test), working memory (Nback) and lexical access (verbal fluency) to reflect executive functioning.
Measured: Month 3
The emotion regulation questionnaire
A questionnaire to measure emotion regulation strategies one favors such as emotion suppression or cognitive reappraisal. This questionnaire has 10 items with a 5-points Likert scale (1 to 5). The score ranges from 5 to 50. A higher score means better emotion regulation strategies.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
The emotion regulation questionnaire
A questionnaire to measure emotion regulation strategies one favors such as A questionnaire to measure emotion regulation strategies one favors such as emotion suppression or cognitive reappraisal. This questionnaire has 10 items with a 5-points Likert scale (1 to 5). The score ranges from 5 to 50. A higher score means better emotion regulation strategies.
Measured: Month 2 (a week after the second intervention)
The emotion regulation questionnaire
A questionnaire to measure emotion regulation strategies one favors such as emotion suppression or cognitive reappraisal. This questionnaire has 10 items with a 5-points Likert scale (1 to 5). The score ranges from 5 to 50. A higher score means better emotion regulation strategies.
Measured: Month 3
Beck Depression Scale
To estimate the level of depression among adults, this scale has 13 items with a 4-points Likert scale (0 to 3). The score ranges from 0 to 39, a higher score means a higher level of depression.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Beck Depression Scale
To estimate the level of depression among adults, this scale has 13 items with a 4-points Likert scale (0 to 3). The score ranges from 0 to 39, a higher score means a higher level of depression.
Measured: Month 2 (a week after the second intervention)
Beck Depression Scale
To estimate the level of depression among adults, this scale has 13 items with a 4-points Likert scale (0 to 3). The score ranges from 0 to 39, a higher score means a higher level of depression.
Measured: Month 3
Fat/lean mass ratio
The bio-electrical impedance analysis measurements will include total body fat mass (FM in kg), and total body lean mass (LM in kg). Then the fat/lean mass (F/L) ratio will be calculated.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Fat/lean mass ratio
The bio-electrical impedance analysis measurements will include total body fat mass (FM in kg), and total body lean mass (LM in kg). Then the fat/lean mass (F/L) ratio will be calculated.
Measured: Month 2 (a week after the second intervention)
Fat/lean mass ratio
The bio-electrical impedance analysis measurements will include total body fat mass (FM in kg), and total body lean mass (LM in kg). Then the fat/lean mass (F/L) ratio will be calculated.
Measured: Month 3
Client satisfaction questionnaire
This survey assesses the patient's satisfaction level of the intervention. Eight items with a 4-points Likert scale (1 to 4) allow to obtain a score between 8 and 32. A higher score means a better satisfaction level.
Measured: Month 1 (Between 1 day and a week before and after the first intervention)
Client satisfaction questionnaire
This survey assesses the patient's satisfaction level of the intervention. Eight items with a 4-points Likert scale (1 to 4) allow to obtain a score between 8 and 32. A higher score means a better satisfaction level.
Measured: Month 2 (a week after the second intervention)
Client satisfaction questionnaire
This survey assesses the patient's satisfaction level of the intervention. Eight items with a 4-points Likert scale (1 to 4) allow to obtain a score between 8 and 32. A higher score means a better satisfaction level.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- * Group 1: physical activity (one month) then cognitive training (one month) * Group 2: Cognitive training (one month) then physical activity (one month) * Group 3 : resonance frequency breathing (one month) then combined physical activity and cognitive (one month) training
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University of Clermont Auvergne (UCA) / LAPSCO
- Responsible party
- Sponsor
- Investigators
- Frédéric Dutheil, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915339
- Sponsor's protocol ID
- RBHP 2020 DUTHEIL
- Other IDs
- 2020-A03228-31
- Acronym
- DIASCOP
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Magnon V, Dutheil F, Tauveron I, Mille J, Baker JS, Brusseau V, Silvert L, Izaute M, Vallet GT. Does an increase in physiological indexes predict better cognitive performance: the PhyCog randomised cross-over protocol in type 2 diabetes. BMJ Open. 2022 Jul 1;12(7):e060057. doi: 10.1136/bmjopen-2021-060057.
PubMed 35777867
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Among Type 2 Diabetes Patients Investigating Effects of Computerized Cognitive and Physical Activity Programs Combined or Single.
- ClinicalTrials.gov ID
- NCT04915339
- Acronym / sponsor ID
- DIASCOP / RBHP 2020 DUTHEIL
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Exercise, Physical fitness, Neuropsychological Tests, Cognition, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University of Clermont Auvergne (UCA) / LAPSCO
- Study start
- Jun 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 7 Jun 2021 (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.
The purpose of this study is to assess the cognitive benefits of combined physical activity and cognitive training on cognitive health compare to physical activity or cognitive training programs singly administrated among type 2 diabetes. Two group in cross over will take part in either physical activity only (for the first one) or cognitive training only (for the second one) for one month then the other way around during the second month. A fallow up will be administrated 3 months later.
Detailed description
The growing Type 2 diabetes prevalence is associated with health, economic and social consequences. As such, type 2 diabetes is recognized as major health issue. Health care should go on after being discharged from the hospital in order to promote cognitive autonomy. Physical activity and cognitive training are two interventions often recommended individually to benefit cognition among type 2 diabetes patients. Yet, a program combining physical activity and cognitive training might be more effective to favor cognitive health.
In this study, diabetes patient between 50 and 75 years old will be allocated randomly in 3 intervention groups in order to have a homogeneous distribution of the education level, sex and age across the 3 samples. The first group will take part in a physical activity program the first month and in a cognitive training one the second. The second group will be cross-over meaning taking part in a cognitive training program the first month and engaging in the physical activity one the second month. The last group will engage in a program based on resonance frequency breathing the first month (as a control condition), then in a combined physical activity and cognitive training program. Between the 2 interventions, there will be a 15 days break (limiting the transfer of the effect of one intervention onto another). At the beginning of the study, a screening will allow to identify possible exclusion criteria (health factors that could influence the main outcomes). At the beginning (baseline) of the first intervention and after each month, neuropsychological tests assessing cognitive and psychological health as well as well-being. Physiological parameters such as heart rate variability, cortisol and DHEA levels, muscle and lean mass, blood circulation (assessed by Laser speckle contrast imaging). A whole session (psychological and physiological testing) should take 1 h 30. Besides, participants will complete online questionnaires. They have one week after the testing to complete those surveys. If they are late an email will be sent before a phone call in the case the delay goes on.
The main outcome is the increase of the cognitive variables after the intervention. It is expected that the physical activity and cognitive training combined program will benefit cognitive functioning more than either of those programs administrated individually. To investigate to long-term effects of the intervention, a fallow up 3 months later will be conduct
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- * Group 1: physical activity (one month) then cognitive training (one month) * Group 2: Cognitive training (one month) then physical activity (one month) * Group 3 : resonance frequency breathing (one month) then combined physical activity and cognitive (one month) training
| Arm | Type | Receives |
|---|---|---|
| Group 1: physical activity then cognitive training | Experimental | Behavioral: Physical activity, Behavioral: cognitive trainingUsing an online-computerized application, physical activities will be prescribed for one month. After a 15 days break, cognitive training activities will be prescribed the same way. A feedback by the patient will be asked fallowing each activity to control the observance. |
| Group 2: Cognitive training then physical activity | Experimental | Behavioral: Physical activity, Behavioral: cognitive trainingContrary to the first group, the second one starts with cognitive training intervention then engages in physical activity in same way as the first group. A feedback by the patient will also be asked fallowing each activity to control the observance |
| Group 3 : resonance frequency breathing then combined physical activity and cognitive training | Experimental | Behavioral: combined physical and cognitive trainingThe third group takes part in a 1 month breathing exercise program. After a 15 days break (as the groups 1 and 2), a combined physical activity and cognitive training program is administrated for 1 month. As the others arms, a feedback by the patient will be asked fallowing each activity to control the observance |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged between 50 and 70 years old, suffering from type 2 diabetes.
- Normal or corrected sight and audition. Being able to engage in physical activity. Being able to give enlightened consent. Being affiliate to social welfare
Key exclusion criteria (2 listed)
- Being unable to meet the study conditions or to answer in French to surveys. Any condition considered, by the investigator, as incompatible with the participation in the study.
- Major incapacities. Refusal of participation.
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 |
|---|---|---|
| Physical activityThe intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables…) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation…). | Behavioural | Group 1: physical activity then cognitive training, Group 2: Cognitive training then physical activity |
| cognitive trainingThe intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables…) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation…). | Behavioural | Group 1: physical activity then cognitive training, Group 2: Cognitive training then physical activity |
| combined physical and cognitive trainingThe intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables…) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation…). | Behavioural | Group 3 : resonance frequency breathing then combined physical activity and cognitive training |
Primary outcome
Episodic memory performances
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Scores are obtained from delayed memory recall tests from the logical memory subtest of the Wechsler memory scale. It consists of two short narrative stories with an immediate recall phase after each story and a delayed recall phase after 10 minutes. During the delayed recall, each correct detail was awarded with one score point. On a scale of 0 to 50, a higher score means a better detailed recall.
Episodic memory performances
Time frame: Month 2 (a week after the second intervention)
Scores are obtained from delayed memory recall tests from the logical memory subtest of the Wechsler memory scale. It consists of two short narrative stories with an immediate recall phase after each story and a delayed recall phase after 10 minutes. During the delayed recall, each correct detail was awarded with one score point. On a scale of 0 to 50, a higher score means a better detailed recall.
Episodic memory performances
Time frame: Month 3
Scores are obtained from delayed memory recall tests from the logical memory subtest of the Wechsler memory scale. It consists of two short narrative stories with an immediate recall phase after each story and a delayed recall phase after 10 minutes. During the delayed recall, each correct detail was awarded with one score point. On a scale of 0 to 50, a higher score means a better detailed recall.
39 secondary outcomes
Heart rate variability
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Heart rate variability
Time frame: Month 2 (a week after the second intervention)
Heart rate variability
Time frame: Month 3
Blood circulation
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Blood circulation
Time frame: Month 2 (a week after the second intervention)
Blood circulation
Time frame: Month 3
Biomarkers of stress
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Biomarkers of stress
Time frame: Month 2 (a week after the second intervention)
Biomarkers of stress
Time frame: Month 3
Body Mass index
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Body Mass index
Time frame: Month 2 (a week after the second intervention)
Body Mass index
Time frame: Month 3
Life satisfaction scale
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Life satisfaction scale
Time frame: Month 2 (a week after the second intervention)
Life satisfaction scale
Time frame: Month 3
Psychological Outcome Profiles
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Psychological Outcome Profiles
Time frame: Month 2 (a week after the second intervention)
Psychological Outcome Profiles
Time frame: Month 3
Interoception awareness questionnaire
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Interoception awareness questionnaire
Time frame: Month 2 (a week after the second intervention)
Interoception awareness questionnaire
Time frame: Month 3
BORB Birmingham Object Recognition Battery
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
BORB Birmingham Object Recognition Battery
Time frame: Month 2 (a week after the second intervention)
BORB Birmingham Object Recognition Battery
Time frame: Month 3
Executive functions
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Executive functions
Time frame: Month 2 (a week after the second intervention)
Executive functions
Time frame: Month 3
The emotion regulation questionnaire
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
The emotion regulation questionnaire
Time frame: Month 2 (a week after the second intervention)
The emotion regulation questionnaire
Time frame: Month 3
Beck Depression Scale
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Beck Depression Scale
Time frame: Month 2 (a week after the second intervention)
Beck Depression Scale
Time frame: Month 3
Fat/lean mass ratio
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Fat/lean mass ratio
Time frame: Month 2 (a week after the second intervention)
Fat/lean mass ratio
Time frame: Month 3
Client satisfaction questionnaire
Time frame: Month 1 (Between 1 day and a week before and after the first intervention)
Client satisfaction questionnaire
Time frame: Month 2 (a week after the second intervention)
Client satisfaction questionnaire
Time frame: Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Derived from this study: PubMed 35777867Magnon V, Dutheil F, Tauveron I, Mille J, Baker JS, Brusseau V, Silvert L, Izaute M, Vallet GT. Does an increase in physiological indexes predict better cognitive performance: the PhyCog randomised cross-over protocol in type 2 diabetes. BMJ Open. 2022 Jul 1;12(7):e060057. doi: 10.1136/bmjopen-2021-060057.
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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.
Frédéric Dutheil principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity, cognitive training and combined physical and cognitive training in people with Diabetes Mellitus, Type 2, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 inclusion and 2 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 7 Jun 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodic memory performances (time frame: Month 1 (Between 1 day and a week before and after the first intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04915339, which also lists 1 linked publication.
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 7 Jun 2021.