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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06343025
Other study ID # Hasan Kalyoncu University
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date September 2025

Study information

Verified date March 2024
Source Nigde Omer Halisdemir University
Contact Gül PEHLIVAN TEKIN, Lecturer
Phone 0388 211 28 60
Email gulpehlivantekin@ohu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study; To investigate the effects of Clinical Pilates and Tai Chi exercises on glycemic control, body composition, balance function and physical activity level in individuals with prediabetes.


Description:

The purpose of this study; To investigate the effects of Clinical Pilates and Tai Chi exercises on glycemic control, body composition, balance function and physical activity level in individuals with prediabetes. Method: 54 individuals diagnosed with Prediabetes in the Endocrinology and Metabolic Diseases Polyclinic at Niğde Ömer Halisdemir Training and Research Hospital will participate in our study. Individuals will be divided into 3 groups: Clinical Pilates group, Tai Chi group and control group. Before exercise, routine blood tests of individuals will be performed and their fasting and postprandial blood glucose and HbA1C (Glycosized Hemoglobin) levels will be checked. Bioelectrical Impedance Device will be used to evaluate body composition. Timed Up and Go Test and Berg Balance Scale will be used to evaluate individuals' balance functions. Physical Activity level of individuals will be measured using the International Physical Activity Level Scale (IPAQ) and the Accelerometer device. Evaluations will be repeated in all groups at the end of the 12-week exercise application. SPSS (Statistical Package Program for Social Science) software will be used to analyze the data. Statistical analysis of the study will be done with Wilcoxon related two-sample test for intra-group measurements, and Man Whitney U test for inter-group evaluations. For the significance level, p value will be accepted as p<0.05.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 54
Est. completion date September 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients who underwent biochemistry analysis for their glycemic control as part of routine checks at the Endocrinology and Metabolic Diseases Polyclinic. - Patients who do not use any medication related to prediabetes - Being able to walk independently - Volunteering to exercise at least 3 days a week within the scope of the research Exclusion Criteria: - Those diagnosed with type 1 diabetes, Latent Autoimmune Diabetes in Adults (LADA) - Going into a diabetic ketoacidosis coma, - Having an orthopedic problem that prevents walking and exercising - Having an orthopedic or vascular problem with the foot - Having any neurological disease - Cardiac, pulmonary or systemic disease that would prevent exercise have - Losing more than 4 kg of weight per month

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates Exercises Group
Individuals will perform clinical pilates exercises for 60 minutes, 3 days a week for 12 weeks. It includes 45 minutes of basic pilates exercises, 10 minutes of warm-up and 5 minutes of cool-down exercises.
Tai Chi Exercises Group
Individuals will perform Tai Chi exercises for 60 minutes, 3 days a week for 12 weeks. It includes 45 minutes of Tai Chi movements, 10 minutes of warm-up and 5 minutes of cool-down exercises.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Nigde Omer Halisdemir University Hasan Kalyoncu University

Outcome

Type Measure Description Time frame Safety issue
Primary Glisemic Control In our study, Hemoglobin A1C (HbA1C), fasting blood glucose and postprandial blood glucose values will be examined from routine biochemistry analyses. 2024- 2025
Primary Body Composition In our study, the body composition of the participants will be evaluated using the Bioelectrical Impedance Device. 2024-2025
Primary Balance In our study, it was decided to use Berg Balance Scale and Timed Up and Go Test to measure balance. 2024-2025
Primary Physical Activity Level In our study, the International Physical Activity Scale (IPAQ) and Accelerometer will be used to determine the physical activity level. 2024-2025
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