Resistance Exercise and Cognition in People With Type 1 Diabetes

NCT05963152 | Unknown

• 1 other identifier: RA HM-2023-010
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

type1diabetes

Keywords

exercise; cognition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Baseline acute change in Paced Auditory Serial Addition Test (PASAT) score

  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

  Change from before (0 hour) to 1 hour post exercise during week 12

• Baseline acute change in Colour Trails Test score

  Change from before (0 hour) to 1 hour post exercise during week 1

• 12 week acute change in Colour Trails Test score

  Change from before (0 hour) to 1 hour post exercise during week 12

Study Arms (3)

Control

PLACEBO COMPARATOR

Habitual Physical Activity

Behavioral: Habitual Physical Activity

Morning exercise

EXPERIMENTAL

Exercise training between 6-10am

Behavioral: Morning Exercise

Afternoon exercise

EXPERIMENTAL

Exercise training between 4-8pm

Behavioral: Afternoon Exercise

Interventions

Habitual Physical Activity BEHAVIORAL

Participants will be asked to maintain their normal activity levels

Control

Morning Exercise BEHAVIORAL

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)

Morning exercise

Afternoon Exercise BEHAVIORAL

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)

Afternoon exercise

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physician confirmed type 1 diabetes for at least 1 year
• Stable insulin therapy for 3 months prior to the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dasman Diabetes Institute: lead

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, 15462, Kuwait

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Ebaa AlOzairi

CONTACT

+965 22242999; ebaa.alozairi@dasmaninstitute.rog

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Model Details: 1:1:1 parallel group design

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 27, 2023
• Study Start: July 20, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)