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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06402578
Other study ID # QMU-IRAS ID: 327162
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date September 2025

Study information

Verified date May 2024
Source Queen Margaret University
Contact Philip Calvert, MSc
Phone 0131 474 0000
Email PCalvert@qmu.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigation into the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing.


Description:

Primary objective: investigate the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing. Secondary objective: evaluate the effects on Cholesterol (ratio of High Density Lipids to Low Density Lipids), Resting Heart Rate, and Body Mass Index after a 12 week physical activity programme. Monitor step counts and sleep patterns during a 12 week physical activity programme.: Methods: Using a RCT is intended to implement dependent variable inductive research into a 12-week e-Health Physical activity (PA) programme with or without physical education support focusing on the blood glucose control in patients with T2DM. Recruitment of 60 patients from hospital out-patient clinics, community diabetic departments, and. NHS patients from general practitioners.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date September 2025
Est. primary completion date July 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - A diagnosis of T2DM in the last 3 years. - Age 18+ years. - Uses the English language as a primary or secondary language with the ability to read and write. - Lives in the United Kingdom. - Has no medical reason preventing participation in regular physical activity. - Has a SMART phone with access to the internet. Exclusion Criteria: - Physical inability to participate in 12 weeks of physical activity. - Cardiac or cardiovascular surgery in the past 6 months. - Musculoskeletal issues that could be aggravated whilst participating in regular physical activity. - Presently participating in a weight loss programme. - Unable to commit to the 12-week feasibility study.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
HbA1c testing
Bloods will be take pre and post 12 week intervention.

Locations

Country Name City State
United Kingdom Queen Margret University Edinburgh Edinburgh Musselburgh

Sponsors (1)

Lead Sponsor Collaborator
Queen Margaret University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c testing blood will be take pre and post trial. 12 weeks
Secondary Cholesterol ratio testing blood will be take pre and post trial. 12 weeks
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