Resistance Exercise and Cognition in People With Type 1 Diabetes

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

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.

Study Overview

• Status: Recruiting
• Conditions: type1diabetes
• Intervention / Treatment: Behavioral: Habitual Physical Activity; Behavioral: Morning Exercise; Behavioral: Afternoon Exercise

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ebaa AlOzairi; Phone Number: 3111 +965 22242999; Email: ebaa.alozairi@dasmaninstitute.rog

Study Locations

• Kuwait
  • Kuwait City, Kuwait, 15462
    • Recruiting
    • Dasman Diabetes Institute
    • Contact: Ebaa AlOZairi
    • Principal Investigator: Ebaa AlOzairi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Habitual Physical Activity	Behavioral: Habitual Physical Activity; Participants will be asked to maintain their normal activity levels
Experimental: Morning exercise; Exercise training between 6-10am	Behavioral: 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)
Experimental: Afternoon exercise; Exercise training between 4-8pm	Behavioral: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dasman Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: exercise; cognition
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RA HM-2023-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No