Clinical trial NCT05029804: Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
Official title: The Effect of Walking Exercise Training Based on the Theoretical Model on Adherence to Disease Management and Metabolic Control in Type 2 Diabetes Patients: A Clinical Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Exercise
Walking Pneumonia
Diabetes
Keywords: Diabetes Mellitus, Type 2
Transtheoritical Model
Walking
Exercise
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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 experimental model with 30 intervention and 30 control individuals. The intervention group will receive the transtheoretical model-based exercise training. Data will be collected using patient a identification form, Patient Compliance Scale to the Treatment of Type 2 Diabetes Mellitus, transtheoretical model scales, pedometer and metabolic outcomes. Data will be analyzed by using Chi square, two-way ANOVA to determine the difference between two or more independent/dependent groups and Spearman's correlation to determine the relationship between two groups.

Eligibility criteria: 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).

Primary outcomes:
measure: Metabolic Parameters 1
timeFrame: The change in 6 months from baseline
measure: Metabolic Parameters 2
timeFrame: The change in 6 months from baseline
measure: Metabolic Parameters 3
timeFrame: The change in 6 months from baseline
measure: Metabolic Parameters 4
timeFrame: The change in 6 months from baseline
measure: Exercise Stages of Change Questionnaire
timeFrame: The change in 6 months from baseline
measure: Exercise Processes of Change Scale
timeFrame: The change in 6 months from baseline
measure: Patient Compliance in Type 2 Diabetes Mellitus Treatment Scale
timeFrame: The change in 6 months from baseline
measure: Pedometer
timeFrame: The change in 6 months from baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ege Uninersity
name: Gulengul Mermer
role: STUDY_DIRECTOR
References: