Pilot Study Among Type 2 Diabetes Patients Investigating the Effects of Computerized Cognitive and Physical Activity Programs Combined or Single (DIASCOP)

Diabetes Mellitus, Type 2 Clinical Trial

— DIASCOP  

Official title:

Pilot Study Among Type 2 Diabetes Patients Investigating Effects of Computerized Cognitive and Physical Activity Programs Combined or Single.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04915339
• Other study ID #: RBHP 2020 DUTHEIL
• Secondary ID: 2020-A03228-31
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: June 2023

Study information

• Verified date: May 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: June 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Physical 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…).
• 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…).
• combined 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…).

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	University of Clermont Auvergne (UCA) / LAPSCO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 1 (Between 1 day and a week before and after the first intervention)
Primary	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.	Month 2 (a week after the second intervention)
Primary	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.	Month 3
Secondary	Heart rate variability	Time interval between two heart beats assessed by a monitoring watch (Empatica E4) and belt (Zephyr Bioharness 3)	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	Heart rate variability	Time interval between two heart beats assessed by a monitoring watch (Empatica E4) and belt (Zephyr Bioharness 3)	Month 2 (a week after the second intervention)
Secondary	Heart rate variability	Time interval between two heart beats assessed by a monitoring watch (Empatica E4) and belt (Zephyr Bioharness 3)	Month 3
Secondary	Blood circulation	Assessed by laser speckle contrast imaging (LSCI).	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	Blood circulation	Assessed by laser speckle contrast imaging (LSCI).	Month 2 (a week after the second intervention)
Secondary	Blood circulation	Assessed by laser speckle contrast imaging (LSCI).	Month 3
Secondary	Biomarkers of stress	A salivary sample to test cortisol level and DHEA.	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	Biomarkers of stress	A salivary sample to test cortisol level and DHEA.	Month 2 (a week after the second intervention)
Secondary	Biomarkers of stress	A salivary sample to test cortisol level and DHEA.	Month 3
Secondary	Body Mass index	The ratio between weight and height will be computed to report BMI in kg/m2.	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	Body Mass index	The ratio between weight and height will be computed to report BMI in kg/m2.	Month 2 (a week after the second intervention)
Secondary	Body Mass index	The ratio between weight and height will be computed to report BMI in kg/m2.	Month 3
Secondary	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.	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	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.	Month 2 (a week after the second intervention)
Secondary	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.	Month 3
Secondary	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	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	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	Month 2 (a week after the second intervention)
Secondary	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	Month 3
Secondary	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.	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	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.	Month 2 (a week after the second intervention)
Secondary	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.	Month 3
Secondary	BORB Birmingham Object Recognition Battery	To assess visuospatial processing by asking the participants if two stimuli are orientated the same way.	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	BORB Birmingham Object Recognition Battery	To assess visuospatial processing by asking the participants if two stimuli are orientated the same way.	Month 2 (a week after the second intervention)
Secondary	BORB Birmingham Object Recognition Battery	To assess visuospatial processing by asking the participants if two stimuli are orientated the same way.	Month 3
Secondary	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.	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	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.	Month 2 (a week after the second intervention)
Secondary	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.	Month 3
Secondary	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.	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	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.	Month 2 (a week after the second intervention)
Secondary	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.	Month 3
Secondary	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.	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	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.	Month 2 (a week after the second intervention)
Secondary	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.	Month 3
Secondary	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.	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	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.	Month 2 (a week after the second intervention)
Secondary	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.	Month 3
Secondary	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.	Month 1 (Between 1 day and a week before and after the first intervention)
Secondary	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.	Month 2 (a week after the second intervention)
Secondary	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.	Month 3