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Resistance Exercise and Cognition in People With Type 1 Diabetes

Sponsor
Dasman Diabetes Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05963152
Collaborator
(none)
54
Enrollment
1
Location
3
Arms
12.4
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Habitual Physical Activity
  • Behavioral: Morning Exercise
  • Behavioral: Afternoon Exercise
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:1:1 parallel group design1:1:1 parallel group design
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effects of Resistance Exercise on Cognition in People With Type 1 Diabetes: a Randomised Controlled Trial
Anticipated Study Start Date :
Jul 20, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Chronic change in Paced Auditory Serial Addition Test (PASAT) score [Change from baseline to 12 weeks]

    Measured using the standardised Paced Auditory Serial Addition Test (PASAT) score ranging from 0-60 with a higher score meaning a better outcome

  2. Chronic change in Colour Trails Test score [Change from baseline to 12 weeks]

    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

  1. Baseline acute change in Paced Auditory Serial Addition Test (PASAT) score [Change from before (0 hour) to 1 hour post exercise during week 1]

    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

  2. 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]

    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

  3. Baseline acute change in Colour Trails Test score [Change from before (0 hour) to 1 hour post exercise during week 1]

    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

  4. 12 week acute change in Colour Trails Test score [Change from before (0 hour) to 1 hour post exercise during week 12]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dasman Diabetes Institute Kuwait City Kuwait 15462

Sponsors and Collaborators

  • Dasman Diabetes Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Ebaa Al Ozairi, Chief Medical Officer, Dasman Diabetes Institute
ClinicalTrials.gov Identifier:
NCT05963152
Other Study ID Numbers:
  • RA HM-2023-010
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Ebaa Al Ozairi, Chief Medical Officer, Dasman Diabetes Institute
exercise
cognition
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jul 28, 2023