- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06343025
The Effects of Tai Chi and Pilates for Individuals With Prediabetes
March 27, 2024 updated by: Nigde Omer Halisdemir University
The Effect of Different Exercise Programs on Glycemic Control, Body Composition, Balance and Physical Activity Level in Individuals With Prediabetes
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gül PEHLİVAN TEKİN, Lecturer
- Phone Number: 2871 0388 211 28 60
- Email: gulpehlivantekin@ohu.edu.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates 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.
In addition, Diet will be recommended by the doctor as routine treatment.
|
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.
|
|
Experimental: Tai Chi 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.
In addition, Diet will be recommended by the doctor as routine treatment.
|
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.
|
|
No Intervention: Control Group
The control group will not be given any training.
Diet and brisk walking 3 days a week will be recommended by the doctor as routine treatment for the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glisemic Control
Time Frame: 2024- 2025
|
In our study, Hemoglobin A1C (HbA1C), fasting blood glucose and postprandial blood glucose values will be examined from routine biochemistry analyses.
|
2024- 2025
|
|
Body Composition
Time Frame: 2024-2025
|
In our study, the body composition of the participants will be evaluated using the Bioelectrical Impedance Device.
|
2024-2025
|
|
Balance
Time Frame: 2024-2025
|
In our study, it was decided to use Berg Balance Scale and Timed Up and Go Test to measure balance.
|
2024-2025
|
|
Physical Activity Level
Time Frame: 2024-2025
|
In our study, the International Physical Activity Scale (IPAQ) and Accelerometer will be used to determine the physical activity level.
|
2024-2025
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
March 27, 2024
First Submitted That Met QC Criteria
March 27, 2024
First Posted (Actual)
April 2, 2024
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
March 27, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HASAN KALYONCU UNIVERSITY
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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