Back to resultsResistance Exercise and Cognition in People With Type 1 Diabetes
Primary Purpose
type1diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
Habitual Physical Activity
Morning Exercise
Afternoon Exercise
Sponsored by
About this trial
This is an interventional basic science trial for type1diabetes focused on measuring exercise, cognition
Eligibility Criteria
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.
Sites / Locations
- Dasman Diabetes InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control
Morning exercise
Afternoon exercise
Arm Description
Habitual Physical Activity
Exercise training between 6-10am
Exercise training between 4-8pm
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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
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
Full Information
NCT ID
NCT05963152
First Posted
July 7, 2023
Last Updated
September 7, 2023
Sponsor
Dasman Diabetes Institute
1. Study Identification
Unique Protocol Identification Number
NCT05963152
Brief Title
Resistance Exercise and Cognition in People With Type 1 Diabetes
Official Title
The Effects of Resistance Exercise on Cognition in People With Type 1 Diabetes: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dasman Diabetes Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
type1diabetes
Keywords
exercise, cognition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1:1 parallel group design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Habitual Physical Activity
Arm Title
Morning exercise
Arm Type
Experimental
Arm Description
Exercise training between 6-10am
Arm Title
Afternoon exercise
Arm Type
Experimental
Arm Description
Exercise training between 4-8pm
Intervention Type
Behavioral
Intervention Name(s)
Habitual Physical Activity
Intervention Description
Participants will be asked to maintain their normal activity levels
Intervention Type
Behavioral
Intervention Name(s)
Morning Exercise
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Afternoon Exercise
Intervention Description
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)
Primary Outcome Measure Information:
Title
Chronic change in Paced Auditory Serial Addition Test (PASAT) score
Description
Measured using the standardised Paced Auditory Serial Addition Test (PASAT) score ranging from 0-60 with a higher score meaning a better outcome
Time Frame
Change from baseline to 12 weeks
Title
Chronic change in Colour Trails Test score
Description
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
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Baseline acute change in Paced Auditory Serial Addition Test (PASAT) score
Description
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
Time Frame
Change from before (0 hour) to 1 hour post exercise during week 1
Title
12 week acute change in Paced Auditory Serial Addition Test (PASAT) score
Description
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
Time Frame
Change from before (0 hour) to 1 hour post exercise during week 12
Title
Baseline acute change in Colour Trails Test score
Description
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
Time Frame
Change from before (0 hour) to 1 hour post exercise during week 1
Title
12 week acute change in Colour Trails Test score
Description
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
Time Frame
Change from before (0 hour) to 1 hour post exercise during week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebaa AlOzairi
Phone
+965 22242999
Ext
3111
Email
ebaa.alozairi@dasmaninstitute.rog
Facility Information:
Facility Name
Dasman Diabetes Institute
City
Kuwait City
ZIP/Postal Code
15462
Country
Kuwait
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebaa AlOZairi
First Name & Middle Initial & Last Name & Degree
Ebaa AlOzairi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Resistance Exercise and Cognition in People With Type 1 Diabetes
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