UnknownNot Applicable

Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes

60 participantsStarted 2021-09-30

Plain-language summary

This study aims to determine the effects of a transtheoretical model-based walking exercise training and disease management and metabolic control in patients with type 2 diabetes. This randomized controlled trial will be conducted as a pre-test and post-test experiment with 30 intervention and 30 control individuals. The intervention group will receive the transtheoretical model-based exercise training. The intervention group will be followed-up for 6 months (from 0 to 6 months) to determine the patients' behavioral changes after the training will be completed.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients who diagnosed with type 2 diabetes at least 6 months. Received insulin and/or oral antidiabetic treatment, literate, and having no communication problems, between the ages of 18 and 65, whose arterial blood pressure is in range of systolic ≤ 160mmHg and diastolic ≤ 100mmHg, who had HbA1c between 7-9 % will be included in the study. The patients who agree to participate in the study (voluntarily) and who have no objection to exercising with cardiology consultation will be included in the study. Exclusion Criteria: Participants with diabetes-related (severe) complications and diabetic foot, pregnancy, diagnosed with cancer, having physical and mental problems that prevent walking will be excluded from the study. HA1C over 9 - despite the treatment (will be referred to the doctor for treatment change). Patients with blood sugar above 300 - despite treatment (will be referred to their doctor for a change in treatment).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Metabolic Parameters 1

Timeframe: The change in 6 months from baseline

Metabolic Parameters 2

Timeframe: The change in 6 months from baseline

Metabolic Parameters 3

Timeframe: The change in 6 months from baseline

Metabolic Parameters 4

Timeframe: The change in 6 months from baseline

Exercise Stages of Change Questionnaire

Timeframe: The change in 6 months from baseline

Exercise Processes of Change Scale

Timeframe: The change in 6 months from baseline

Patient Compliance in Type 2 Diabetes Mellitus Treatment Scale

Timeframe: The change in 6 months from baseline

Trial details

NCT IDNCT05029804

SponsorEge University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

Contact for this trial

Gulengul Mermer, Ph.D

+902323115536 gulengulmermer@gmail.com

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Metabolic Parameters 1

Timeframe: The change in 6 months from baseline

Metabolic Parameters 2

Timeframe: The change in 6 months from baseline

Metabolic Parameters 3

Timeframe: The change in 6 months from baseline

Metabolic Parameters 4

Timeframe: The change in 6 months from baseline

Exercise Stages of Change Questionnaire

Timeframe: The change in 6 months from baseline

Exercise Processes of Change Scale

Timeframe: The change in 6 months from baseline

Patient Compliance in Type 2 Diabetes Mellitus Treatment Scale

Timeframe: The change in 6 months from baseline