Diabetes Mellitus, Type 2 Clinical Trial
— DIASCOPOfficial 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.
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. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | University of Clermont Auvergne (UCA) / LAPSCO |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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