The Effect of The Walking Exercise Training Given According to Transtheoretical Model, and Follow-Up on Improving Exercise Behavior and Metabolic Control in Type 2 Diabetic Patients
24 aprile 2018 aggiornato da: Emine KAPLAN SERIN, Emine Kaplan Serin
OBJECTIVE This study aims to find out the effects of walking exercise training, which is given according to Transtheoretical Model (TTM), and follow-up on improving exercise behavior and metabolic control in type 2 diabetic patients.
RESEARCH DESIGN AND METHODS The study was conducted as a pre-test, post-test experimental model with 76 intervention (INT) groups and 76 control (CON) groups adult type 2 diabetic patients providing the criteria of the study and followed-up by the diabetes polyclinic of Adıyaman Education and Research Hospital. Patient introduction form (PIF), TTM scales and pedometer were used to collect the data. TTM based training was given to the intervention group according to the patients' change stages at hospital 10 weeks once per every 2 weeks. PIF, TTM scales were applied after the training. PIF, TTM scales were applied to the groups 9 months after the pre-test again.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
152
Fase
- Non applicabile
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 were diagnosed with type-2 diabetes at least six months before, received basic diabetes information, received insulin and/or oral antidiabetic treatment, whose arterial blood pressure was in systolic ≤ 160 mmHg and diastolic ≤ 100 mmHg, who had HbA1c 7% and over, who were literate and had no communication problems were included in the study.
Exclusion Criteria:
- Those who had developed diabetes-related complications (advanced), were pregnant, diagnosed with cancer, had physical and mental problems that prevent walking were excluded from the study.
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: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intervento
|
Altri nomi:
|
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Nessun intervento: Controllo
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient Presentation Form
Lasso di tempo: baseline collected
|
The patient presentation form includes questions that question the sociodemographic characteristics and habits of patients, their knowledge of diabetes and its treatment, their exercise status
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baseline collected
|
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questions that evaluate the metabolic control variables.
Lasso di tempo: Change from Baseline at 9 months
|
FBS, SBS, total cholesterol, HbA1c, LDL, triglyceride, diastolic and systolic BP
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Change from Baseline at 9 months
|
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Stages of Change for Exercise Questionnaire
Lasso di tempo: Change from Baseline at 9 months
|
It was developed by Prochaska and DiClemente, adapted by Marcus et al. to exercise.
It was adapted to Turkish society by Ay and Temel in 2007.
The scale consists of five questions and reveals the stage of change where the individual in (pre-thinking, thinking, preparation, taking action and maintenance).
|
Change from Baseline at 9 months
|
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Exercise Processes of Change Scale
Lasso di tempo: Change from Baseline at 9 months
|
It was developed by Marcus et al. and adapted to Turkish society by Ay and Temel.
Exercise Processes of Change Scale is based on a 5-point Likert type and consists of 28 items.
The maximum score that an individual can get on the scale is 140, the minimum score is 28.
The scale consists of 10 sub-dimensions and 2 main processes (behavioral process and cognitive process) facilitating change involving these sub-dimensions.
Cognitive processes are increased awareness, dramatic help, environmental reassessment, self-reassessment, social independence.
Behavioral processes are opposition, helping relationships, empowerment management, self-emancipation and stimulus control.
The higher scale scores indicate the higher chance of success of the change.
|
Change from Baseline at 9 months
|
|
Exercise Self-Efficacy Scale
Lasso di tempo: Change from Baseline at 9 months
|
It was developed by Marcus et al. and adapted to Turkish society by Ay and Temel.
The scale consists of six items, in the form of five-point Likert.
The maximum score that can be taken from the scale is 30 and the minimum score is 6.
In the general evaluation of the scale, according to the general average composed of item score averages, the self-efficacy of high-value-average subjects is high, and the self-efficacy of subjects below the average is considered to be low.
|
Change from Baseline at 9 months
|
|
Exercise Decisional Balance Scale
Lasso di tempo: Change from Baseline at 9 months
|
It was developed by Marcus et al. and adapted to Turkish society by Ay and Temel.
There are two sub-dimensions that assess subjective perception including perceived benefits of exercise practice and perceived harmfulness of exercise.
The scale is based on 5 point Likert type and consists of 10 items.
The overall score of the scale is formed by subtracting the total score of the perceived harmfulness from the total score of the perceived benefit of the exercise practice.
The maximum score can be taken from the scale is 20 and the minimum score is -20.
The negative result indicates that in the exercise decisional balance, the perceived harmfulness is dominant and the positive result indicates that the perceived benefit of exercise practice is dominant on the scale.
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Change from Baseline at 9 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 (Effettivo)
25 ottobre 2015
Completamento primario (Effettivo)
30 novembre 2016
Completamento dello studio (Effettivo)
30 novembre 2016
Date di iscrizione allo studio
Primo inviato
9 aprile 2018
Primo inviato che soddisfa i criteri di controllo qualità
24 aprile 2018
Primo Inserito (Effettivo)
7 maggio 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 maggio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 aprile 2018
Ultimo verificato
1 aprile 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MunzurU
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 .