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

A Feasibility Randomised Controlled Trial to Investigate the Effects of a 12-week Digital Physical Activity Programme, With or Without Physical Education Support, on Blood Glucose Control in Patients With Type 2 Diabetes Mellitus

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06402578
Enrollment
60
Registered
2024-05-07
Start date
2024-06-30
Completion date
2025-09-30
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

HbA1c, Cholesterol, Resting Heart Rate

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTHbA1c testing

Bloods will be take pre and post 12 week intervention.

Sponsors

Queen Margaret University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Intervention model description

At the point of consent the participants will be randomised to one of three allocated groups. Control group, Intervention 1 or Intervention 2.

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
HbA1c testing12 weeksblood will be take pre and post trial.

Secondary

MeasureTime frameDescription
Cholesterol ratio testing12 weeksblood will be take pre and post trial.

Countries

United Kingdom

Contacts

Primary ContactPhilip Calvert, MSc
PCalvert@qmu.ac.uk0131 474 0000
Backup ContactDerek Santos, PHD
DSantos@qmu.ac.uk0131 474 0000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026