Resistance Exercise and Cognition in People With Type 1 Diabetes

type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963152
• Other study ID #: RA HM-2023-010
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2023
• Source: Dasman Diabetes Institute
• Contact: Ebaa AlOzairi
• Phone: +965 22242999
• Email: ebaa.alozairi[@]dasmaninstitute.rog
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• type1diabetes

Intervention

Behavioral:
• Habitual Physical Activity
Participants will be asked to maintain their normal activity levels
• Morning Exercise
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)
• Afternoon Exercise
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)

Locations

Country	Name	City	State
Kuwait	Dasman Diabetes Institute	Kuwait City

Sponsors (1)

Lead Sponsor	Collaborator
Dasman Diabetes Institute

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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