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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Physical activity; Behavioral: cognitive training; Behavioral: combined physical and cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT04915339

RBHP 2020 DUTHEIL

2020-A03228-31 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 81 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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81 participants in 3 patient groups

Group 1: physical activity then cognitive training

Experimental group

Description:

Using 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.

Treatment:

Behavioral: Physical activity

Behavioral: cognitive training

Group 2: Cognitive training then physical activity

Experimental group

Description:

Contrary 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

Treatment:

Behavioral: Physical activity

Behavioral: cognitive training

Group 3 : resonance frequency breathing then combined physical activity and cognitive training

Experimental group

Description:

The 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

Treatment:

Behavioral: combined physical and cognitive training