Diabetes Mellitus, Type 2
Conditions
Keywords
Exercise, Physical fitness, Neuropsychological Tests, Cognition, Diabetes Mellitus, Type 2
Brief 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. 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
Interventions
BEHAVIORALPhysical activity
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…).
BEHAVIORALcognitive training
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…).
BEHAVIORALcombined physical and cognitive training
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…).
Sponsors
University of Clermont Auvergne (UCA) / LAPSCO
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The study hypothesis is not given to the participants and the investigator will not be aware of the group the participants have been allocated to.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Episodic memory performances | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood circulation | Month 1 (Between 1 day and a week before and after the first intervention) | Assessed by laser speckle contrast imaging (LSCI). |
| Biomarkers of stress | Month 1 (Between 1 day and a week before and after the first intervention) | A salivary sample to test cortisol level and DHEA. |
| Body Mass index | Month 1 (Between 1 day and a week before and after the first intervention) | The ratio between weight and height will be computed to report BMI in kg/m2. |
| Life satisfaction scale | Month 1 (Between 1 day and a week before and after the first intervention) | 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. |
| Psychological Outcome Profiles | Month 1 (Between 1 day and a week before and after the first intervention) | 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 |
| Interoception awareness questionnaire | Month 1 (Between 1 day and a week before and after the first intervention) | 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. |
| Heart rate variability | Month 1 (Between 1 day and a week before and after the first intervention) | Time interval between two heart beats assessed by a monitoring watch (Empatica E4) and belt (Zephyr Bioharness 3) |
| Executive functions | Month 1 (Between 1 day and a week before and after the first intervention) | 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. |
| The emotion regulation questionnaire | Month 1 (Between 1 day and a week before and after the first intervention) | 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. |
| Beck Depression Scale | Month 1 (Between 1 day and a week before and after the first intervention) | 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. |
| Fat/lean mass ratio | Month 1 (Between 1 day and a week before and after the first intervention) | 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. |
| Client satisfaction questionnaire | Month 1 (Between 1 day and a week before and after the first intervention) | 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. |
| BORB Birmingham Object Recognition Battery | Month 1 (Between 1 day and a week before and after the first intervention) | To assess visuospatial processing by asking the participants if two stimuli are orientated the same way. |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed