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

27 agosto 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Anticipato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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).
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Metabolic Parameters 1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ege University

Investigatori

  • Direttore dello studio: Gulengul Mermer, Ege Uninersity

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

30 settembre 2021

Completamento primario (Anticipato)

30 settembre 2022

Completamento dello studio (Anticipato)

30 dicembre 2022

Date di iscrizione allo studio

Primo inviato

19 agosto 2021

Primo inviato che soddisfa i criteri di controllo qualità

27 agosto 2021

Primo Inserito (Effettivo)

1 settembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 settembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 agosto 2021

Ultimo verificato

1 agosto 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Type2DiabetesEge

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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