Clinical trial NCT04915339: Pilot Study Among Type 2 Diabetes Patients Investigating the Effects of Computerized Cognitive and Physical Activity Programs Combined or Single (DIASCOP)
Official title: Pilot Study Among Type 2 Diabetes Patients Investigating Effects of Computerized Cognitive and Physical Activity Programs Combined or Single.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Exercise
Physical fitness
Neuropsychological Tests
Cognition
Diabetes Mellitus, Type 2
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University of Clermont Auvergne (UCA) / LAPSCO
First posted: 2021-06-07
Enrollment: 81
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Episodic memory performances
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Episodic memory performances
timeFrame: Month 2 (a week after the second intervention)
measure: Episodic memory performances
timeFrame: Month 3
Secondary outcomes:
measure: Heart rate variability
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Heart rate variability
timeFrame: Month 2 (a week after the second intervention)
measure: Heart rate variability
timeFrame: Month 3
measure: Blood circulation
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Blood circulation
timeFrame: Month 2 (a week after the second intervention)
measure: Blood circulation
timeFrame: Month 3
measure: Biomarkers of stress
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Biomarkers of stress
timeFrame: Month 2 (a week after the second intervention)
measure: Biomarkers of stress
timeFrame: Month 3
measure: Body Mass index
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Body Mass index
timeFrame: Month 2 (a week after the second intervention)
measure: Body Mass index
timeFrame: Month 3
measure: Life satisfaction scale
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Life satisfaction scale
timeFrame: Month 2 (a week after the second intervention)
measure: Life satisfaction scale
timeFrame: Month 3
measure: Psychological Outcome Profiles
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Psychological Outcome Profiles
timeFrame: Month 2 (a week after the second intervention)
measure: Psychological Outcome Profiles
timeFrame: Month 3
measure: Interoception awareness questionnaire
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Interoception awareness questionnaire
timeFrame: Month 2 (a week after the second intervention)
measure: Interoception awareness questionnaire
timeFrame: Month 3
measure: BORB Birmingham Object Recognition Battery
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: BORB Birmingham Object Recognition Battery
timeFrame: Month 2 (a week after the second intervention)
measure: BORB Birmingham Object Recognition Battery
timeFrame: Month 3
measure: Executive functions
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Executive functions
timeFrame: Month 2 (a week after the second intervention)
measure: Executive functions
timeFrame: Month 3
measure: The emotion regulation questionnaire
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: The emotion regulation questionnaire
timeFrame: Month 2 (a week after the second intervention)
measure: The emotion regulation questionnaire
timeFrame: Month 3
measure: Beck Depression Scale
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Beck Depression Scale
timeFrame: Month 2 (a week after the second intervention)
measure: Beck Depression Scale
timeFrame: Month 3
measure: Fat/lean mass ratio
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Fat/lean mass ratio
timeFrame: Month 2 (a week after the second intervention)
measure: Fat/lean mass ratio
timeFrame: Month 3
measure: Client satisfaction questionnaire
timeFrame: Month 1 (Between 1 day and a week before and after the first intervention)
measure: Client satisfaction questionnaire
timeFrame: Month 2 (a week after the second intervention)
measure: Client satisfaction questionnaire
timeFrame: Month 3
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric Dutheil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.