Pilot Study Among Type 2 Diabetes Patients Investigating the Effects of Computerized Cognitive and Physical Activity Programs Combined or Single (DIASCOP)
DIASCOP
2 other identifiers
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Jun 2021
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 7, 2021
May 1, 2021
1.3 years
May 21, 2021
May 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
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)
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 Outcomes (39)
Heart rate variability
Month 1 (Between 1 day and a week before and after the first intervention)
Heart rate variability
Month 2 (a week after the second intervention)
Heart rate variability
Month 3
Blood circulation
Month 1 (Between 1 day and a week before and after the first intervention)
Blood circulation
Month 2 (a week after the second intervention)
- +34 more secondary outcomes
Study Arms (3)
Group 1: physical activity then cognitive training
EXPERIMENTALUsing 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
EXPERIMENTALContrary 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
EXPERIMENTALThe 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
Interventions
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…).
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…).
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…).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
Related Publications (1)
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.
PMID: 35777867DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric Dutheil
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2021
First Posted
June 7, 2021
Study Start
June 1, 2021
Primary Completion
September 1, 2022
Study Completion
June 1, 2023
Last Updated
June 7, 2021
Record last verified: 2021-05