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

NCT ID: NCT05029804

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-12-30

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.

Conditions

Diabetes Mellitus, Type 2; Exercise; Walking Pneumonia; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

After the initial assessment, patients in this group will be educated by the researcher on walking exercise by using the transtheoritical model. The data will be collected from the patients in the experimental group at baseline, 1st, 3rd, and 6th months of the programme.

The data will be collected by using Exercise Stages of Change Questionnaire, Exercise Processes of Change Scale, Pedometer, Patient Compliance in Type 2 Diabetes Mellitus Treatment Scale, and patient identification that includes five domain. These domains include questions about the patients' sociodemographic characteristics, habits, knowledge of diabetes and its treatment, exercise status, and the evaluation of the metabolic control variables.

Group Type: EXPERIMENTAL

Education

Intervention Type: OTHER

This intervention will be applied to the patients in the experimental group. The education will be provided by the researcher and based on the transtheoritical model. Printed materials and PowerPoint presentations will be used for the education and the education will be conducted in a face-to-face session with each participant (10 weeks).

Control

No intervention will be applied to this group. The data will be collected from the patients in the control group at baseline, 1st, 3rd, and 6th months.

The data will be collected by using Exercise Stages of Change Questionnaire, Exercise Processes of Change Scale, Pedometer, Patient Compliance in Type 2 Diabetes Mellitus Treatment Scale, and patient identification that includes five domain. These domains included questions about the patients' sociodemographic characteristics, habits, knowledge of diabetes and its treatment, exercise status, and the evaluation of the metabolic control variables.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education

This intervention will be applied to the patients in the experimental group. The education will be provided by the researcher and based on the transtheoritical model. Printed materials and PowerPoint presentations will be used for the education and the education will be conducted in a face-to-face session with each participant (10 weeks).

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Gulengul Mermer

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulengul Mermer

Role: STUDY_DIRECTOR

Ege Uninersity

Central Contacts

Gulengul Mermer, Ph.D

Role: CONTACT

gulengulmermer@gmail.com

+902323115536

Other Identifiers

Type2DiabetesEge

Identifier Type: -

Identifier Source: org_study_id