type1diabetesNCT05963152
Resistance Exercise and Cognition in People With Type 1 Diabetes
A study testing Habitual Physical Activity, Morning Exercise and Afternoon Exercise in people with type1diabetes, run by Dasman Diabetes Institute at 1 site in Kuwait.
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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- type1diabetes
- What is being tested?
- Habitual Physical Activity, Morning Exercise and Afternoon Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteKuwait
- Study dates
- 20 Jul 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physician confirmed type 1 diabetes for at least 1 year
- Stable insulin therapy for 3 months prior to the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
Dasman Diabetes Institute
Kuwait City, 15462
Ebaa AlOZairi
Ebaa AlOzairi
About this study
Official title: 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.
- Conditions
- type1diabetes
- Being tested
- Habitual Physical Activity, Morning Exercise, Afternoon Exercise
- Keywords
- exercise, cognition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habitual Physical ActivityBehavioural
Participants will be asked to maintain their normal activity levels
Morning ExerciseBehavioural
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 ExerciseBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Habitual Physical Activity Receives: Behavioral: Habitual Physical Activity |
| Morning exercise | Experimental | Exercise training between 6-10am Receives: Behavioral: Morning Exercise |
| Afternoon exercise | Experimental | Exercise training between 4-8pm Receives: Behavioral: Afternoon Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from baseline to 12 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from before (0 hour) to 1 hour post exercise during week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start20 Jul 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 parallel group design
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ebaa Al Ozairi, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963152
- Sponsor's protocol ID
- RA HM-2023-010
- Status last verified
- Sep 2023
- First submitted
- 7 Jul 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resistance Exercise on Cognition in People With Type 1 Diabetes: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05963152
- Acronym / sponsor ID
- RA HM-2023-010
- Conditions
- type1diabetes
- Keywords
- exercise, cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1:1:1 parallel group design
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Habitual Physical ActivityHabitual Physical Activity |
| Morning exercise | Experimental | Behavioral: Morning ExerciseExercise training between 6-10am |
| Afternoon exercise | Experimental | Behavioral: Afternoon ExerciseExercise training between 4-8pm |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physician confirmed type 1 diabetes for at least 1 year
- Stable insulin therapy for 3 months prior to the study
Key exclusion criteria (8 listed)
- BMI of 45 or higher
- BP of 160/100mmHg or higher
- autonomic neuropathy
- severe proliferative retinopathy
- joint or limb injuries preventing weight-bearing activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Habitual Physical ActivityParticipants will be asked to maintain their normal activity levels | Behavioural | Control |
| Morning ExerciseBetween 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) | Behavioural | Morning exercise |
| Afternoon ExerciseBetween 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) | Behavioural | Afternoon exercise |
Primary outcome
Chronic change in Paced Auditory Serial Addition Test (PASAT) score
Time frame: 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
Chronic change in Colour Trails Test score
Time frame: 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
4 secondary outcomes
Baseline acute change in Paced Auditory Serial Addition Test (PASAT) score
Time frame: 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
Time frame: Change from before (0 hour) to 1 hour post exercise during week 12
Baseline acute change in Colour Trails Test score
Time frame: Change from before (0 hour) to 1 hour post exercise during week 1
12 week acute change in Colour Trails Test score
Time frame: Change from before (0 hour) to 1 hour post exercise during week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habitual Physical Activity, Morning Exercise and Afternoon Exercise in people with type1diabetes, run by Dasman Diabetes Institute at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebaa AlOzairi (+965 22242999 ext. 3111, ebaa.alozairi@dasmaninstitute.rog), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic change in Paced Auditory Serial Addition Test (PASAT) score (time frame: Change from baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.