Resistance Exercise and Cognition in People With Type 1 Diabetes

Study Overview
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Brief Summary
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The aim of the current study is to determine the effects of resistance exercise on performance of the Paced Auditory Serial Addition Test and the Colour Trails Test.

Official Title
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The Effects of Resistance Exercise on Cognition in People With Type 1 Diabetes: a Randomised Controlled Trial

Conditions
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type1diabetes

Intervention / Treatment
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* Behavioral: Habitual Physical Activity
* Behavioral: Morning Exercise
* Behavioral: Afternoon Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician confirmed type 1 diabetes for at least 1 year Stable insulin therapy for 3 months prior to the study Exclusion Criteria: BMI of 45 or higher BP of 160/100mmHg or higher autonomic neuropathy severe proliferative retinopathy joint or limb injuries preventing weight-bearing activity autonomic neuropathy severe proliferative retinopathy any other medical condition that prevents participants from exercising safely.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1:1 parallel group design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Habitual Physical Activity | Behavioral: Habitual Physical Activity<br>* Participants will be asked to maintain their normal activity levels<br>|
| Experimental: Morning exercise<br>Exercise training between 6-10am | Behavioral: Morning Exercise<br>* Between 6-10am participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)<br>|
| Experimental: Afternoon exercise<br>Exercise training between 4-8pm | Behavioral: Afternoon Exercise<br>* Between 4-8pm participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic change in Paced Auditory Serial Addition Test (PASAT) score | Measured using the standardised Paced Auditory Serial Addition Test (PASAT) score ranging from 0-60 with a higher score meaning a better outcome | Change from baseline to 12 weeks | 
| Chronic change in Colour Trails Test score | Measured using the standardised Colour Trails Test, with score based on completion time (0-240s), number of errors, error type, and number of prompts with a shorter completion time and lower number of errors and prompts indicating a better outcome | Change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline acute change in Paced Auditory Serial Addition Test (PASAT) score | Measured using the standardised Paced Auditory Serial Addition Test (PASAT) during the first exercise session, score ranging from 0-60 with a higher score meaning a better outcome | Change from before (0 hour) to 1 hour post exercise during week 1 | 
| 12 week acute change in Paced Auditory Serial Addition Test (PASAT) score | Measured using the standardised Paced Auditory Serial Addition Test (PASAT) during the last exercise session, score ranging from 0-60 with a higher score meaning a better outcome | Change from before (0 hour) to 1 hour post exercise during week 12 | 
| Baseline acute change in Colour Trails Test score | Measured using the standardised Colour Trails Test during the first exercise session, with score based on completion time (0-240s), number of errors, error type, and number of prompts with a shorter completion time and lower number of errors and prompts indicating a better outcome | Change from before (0 hour) to 1 hour post exercise during week 1 | 
| 12 week acute change in Colour Trails Test score | Measured using the standardised Colour Trails Test during the last exercise session, with score based on completion time (0-240s), number of errors, error type, and number of prompts with a shorter completion time and lower number of errors and prompts indicating a better outcome | Change from before (0 hour) to 1 hour post exercise during week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, cognition