Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT05411458
Brief Summary:
Type-2 Diabetes Mellitus (DM) disease, like other chronic diseases, is a group of diseases that are adversely affected by the COVID-19 pandemic.This study was planned to examine the effect of COVID-19 disease on patients with Type-2 DM and to investigate the effects of progressive relaxation exercises to be given as tele-rehabilitative on stress, anxiety and blood glucose levels and HbA1c value.
Detailed Description:
30 Type-2 DM patients whose diabetes examinations and treatments were performed by an internist in the internal medicine outpatient clinic of Izmir Bozyaka Training and Research Hospital will be included in the study. (study group: 15 cases who had COVID-19 at least three months ago and control group: 15 cases who did not have COVID-19) Physical characteristics such as age (year), gender, body weight (kg), height (cm), body mass index (kg/m2) and sociodemographic characteristics of the cases were questioned. Evaluated by anthropometric measurements (waist and hip circumference (cm) and waist and body composition measurement (Xiaomi MI scale 2).
Diabetes knowledge levels were determined by the Diabetes Knowledge Test (DKT2), physical activity levels were determined by the International Physical Activity Questionnaire-Short form (IPAQ-short form), and sleep quality was determined by the Pittsburg Sleep Quality Index (PUKI). Blood values such as fasting blood glucose (mg/dl), Glycosylated Hemoglobin (HbA1c) (%) of the cases were measured, and the patient was taught to measure the heart rate (beats/minute) in a radial way. Functional capacity levels were determined by the 6-minute walking test (6MWT), lower extremity muscle strength by the Five-Time Sitting Stand Up Test (FTSST), stress levels by the Perceived Stress Scale (PSS) and anxiety levels by Spielberg's State-Trait Anxiety Inventory (STAI-S and T). ) were evaluated with Quality of life was measured with the Short Form-12 (SF-12) and Diabetes-Specific Quality of Life Scale (DQOL).
All evaluations were made face to face with all cases in both groups at the beginning of the study. Then, the same exercise training was applied to the patients in both groups as rehabilitative, in a crossover design, in a random order determined by the lottery for a total of 12 weeks.
12-week treatment program A - 6 weeks of Aerobic exercise (AE) (outdoor walking program) B - 6 week program - Jacobson Progressive Relaxation Exercises (JIGE) (performed by patients at home) were administered in addition to aerobic exercise (AE) (outdoor walking program).
The exercise program is 30-45 minutes and the applications are done every other day and 3 days a week. Patients recorded their Heart Rate (beats/minute) before and after each administration.
The Five Times Standing Test (FTSST) and STAI-S were performed at 6 weeks following treatment (at treatment changes). At the end of the treatment, that is, at the 12th week; 6 DYT and Five Time Sit to Stand Test (FTSST) and IPAQ-short form, SF-12 and DQOL, PSS, STAI-S and T, PUKI scales were re-evaluated. The efficacy of treatments will be compared within and between groups using appropriate statistical methods.
Study:
NCT05411458
Study Brief:
Protocol Section:
NCT05411458