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

27 de agosto de 2021 actualizado por: Gulengul Mermer, Ege University

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

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otro: 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).
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Metabolic Parameters 1
Periodo de tiempo: The change in 6 months from baseline
Fasting Blood Glucose (mg/dL), the fasting blood glucose will be assessed by taking blood sample from the patients.sample from the patients.
The change in 6 months from baseline
Metabolic Parameters 2
Periodo de tiempo: The change in 6 months from baseline
HbA1c (both % and mmol/mol), the HbA1c will be assessed by taking blood sample from the patients.
The change in 6 months from baseline
Metabolic Parameters 3
Periodo de tiempo: The change in 6 months from baseline
Total cholesterol (mg/dL), the total cholesterol will be assessed by taking blood sample from the patients.
The change in 6 months from baseline
Metabolic Parameters 4
Periodo de tiempo: The change in 6 months from baseline
Creatinine (mg/dL), the creatinine will be assessed by taking blood sample from the patients.
The change in 6 months from baseline
Exercise Stages of Change Questionnaire
Periodo de tiempo: The change in 6 months from baseline
Prochaska et al. (1992) studied how people change. Marcus et al. developed a structured questionnaire to measure the stages of exercise changes. Ay and Temel (2015) adapted the questionnaire to Turkish society. The scale consists of five questions about the patient's stage of change (prethinking, thinking, preparation, taking action, and maintenance). In the pre-thinking stage, the patients do not plan to start exercise now or during the next 6 months. The patients in the thinking stage do not make an effort to exercise actively, but intend to start in the next 6 months. The patients in the preparation stage intend to start exercising regularly in the next 30 days. The patients in the taking action stage have started exercising within the last 6 months. The patients in the maintenance stage continue to change over the course of the action, exercise more than 6 months and are confident and determined not to return to previous behavior.
The change in 6 months from baseline
Exercise Processes of Change Scale
Periodo de tiempo: The change in 6 months from baseline
The exercise processes of change scale was developed by Marcus et al. and adapted to Turkish society by Ay and Temel. Exercise processes of change is based on a 5-point Likert type scale and consists of 28 items. The maximum score that a patient can obtain on the scale is 140, the minimum score is 28. The scale consists of 10 sub-dimensions and two main processes (behavioral and cognitive). Behavioral processes are opposition, helping relationships, empowerment management, self-emancipation and stimulus control. Cognitive processes are increased awareness, dramatic help, environmental reassessment, self reassessment, social independence. The higher the scale score is indicates a higher success of the change. In this study, the general Cronbach alpha reliability coefficient of the scale was determined as 0.96 (behavioral process = 0.94 and cognitive process = 0.93).
The change in 6 months from baseline
Patient Compliance in Type 2 Diabetes Mellitus Treatment Scale
Periodo de tiempo: The change in 6 months from baseline
This scale consists of 30 questions and a five-point Likert type rating is used. There are 13 positive and 17 negative items in the scale. Scoring ranges from 1 to 5 for positive items, and reverse scoring ranges from 5 to 1 for negative items. The highest score obtained from the scale is 150, the lowest score is 30. 30-54 points from the scale indicates "good adherence to treatment", 55-125 points "medium adherence to treatment", and 126-150 points indicate that the patient's adherence to treatment is poor. The scale was developed by Demirtaş and Albayrak for use in Turkish society. Cronbach's alpha value was found to be 0.77.
The change in 6 months from baseline
Pedometer
Periodo de tiempo: The change in 6 months from baseline
A pedometer is a portable, small, inexpensive, and objective tool used to measure the number of steps. The pedometer includes a mechanical motion sensitive sensor that detects movements during walking. To prevent diseases and encourage healthy lifestyles, 150 minutes exercise and 10,000 steps per day are recommended. The researcher will provide participants with Omron brand HJ-320-E model pedometers to record 7days of activity data. These records were used to calculate the average number of steps per day.
The change in 6 months from baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ege University

Investigadores

  • Director de estudio: Gulengul Mermer, Ege Uninersity

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

30 de septiembre de 2021

Finalización primaria (Anticipado)

30 de septiembre de 2022

Finalización del estudio (Anticipado)

30 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

19 de agosto de 2021

Primero enviado que cumplió con los criterios de control de calidad

27 de agosto de 2021

Publicado por primera vez (Actual)

1 de septiembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de septiembre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

27 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Type2DiabetesEge

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Descripción del plan IPD

We do not plan to share individual participant data to other researchers

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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