A 12-week Digital Physical Activity Programme, With or Without Physical Education Support for Type 2 Diabetes Patients.

Queen Margaret University

Status: Not yet enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Diagnostic Test: HbA1c testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06402578

QMU-IRAS ID: 327162

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Control Group,

No Intervention group

Description:

Control Group, will be issued with a smartwatch that is paired with a freely accessible App called Alexia® to record their PA. They will be asked to carry on with their daily activity and to record when they do any of their own physical activities that they do themselves routinely on an everyday basis during the 12 week study. They will not receive a 12 week PA programme.

Intervention 1

Experimental group

Description:

Intervention 1, will be provided with a 12 week PA programme and asked to record their PA while they follow the programme during the 12 week study.

Treatment:

Diagnostic Test: HbA1c testing

Intervention 2

Experimental group

Description:

Intervention 2, will also be provided with the same 12 week PA program and asked to record their PA while they follow the programme during the 12 week study. The participants in this group will also get support from a physical activity professional (PAP) who will be monitoring their 12 week journey. The PAP will be prompting the participant with weekly information as to why they are doing these exercises as well as supporting the participants to continue their programme as soon as non-adherence to the exercise program becomes apparent during the 12 week study.

Treatment:

Diagnostic Test: HbA1c testing