PreDiabetesNCT06343025
The Effects of Tai Chi and Pilates for Individuals With Prediabetes
A study testing Pilates Exercises Group and Tai Chi Exercises Group in people with PreDiabetes, run by Nigde Omer Halisdemir University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Pilates Exercises Group and Tai Chi Exercises Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- Pilates Exercises Group, Tai Chi Exercises Group
- Keywords
- prediabetes, Tai Chi, Pilates, Exercise
- Medical subject headings
- Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates Exercises GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | 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. Receives: Other: Pilates Exercises Group |
| Tai Chi Group | Experimental | 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. Receives: Other: Tai Chi Exercises Group |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Glisemic Control
In our study, Hemoglobin A1C (HbA1C), fasting blood glucose and postprandial blood glucose values will be examined from routine biochemistry analyses.
Measured: 2024- 2025
Body Composition
In our study, the body composition of the participants will be evaluated using the Bioelectrical Impedance Device.
Measured: 2024-2025
Balance
In our study, it was decided to use Berg Balance Scale and Timed Up and Go Test to measure balance.
Measured: 2024-2025
Physical Activity Level
In our study, the International Physical Activity Scale (IPAQ) and Accelerometer will be used to determine the physical activity level.
Measured: 2024-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be divided into 3 groups: Clinical Pilates group, Tai Chi group and Control group. 3 groups. 3 groups will be measured at the same time and then the exercise part will begin.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Collaborators
- Hasan Kalyoncu University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343025
- Sponsor's protocol ID
- Hasan Kalyoncu University
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Exercise Programs on Glycemic Control, Body Composition, Balance and Physical Activity Level in Individuals With Prediabetes
- ClinicalTrials.gov ID
- NCT06343025
- Acronym / sponsor ID
- Hasan Kalyoncu University
- Conditions
- PreDiabetes
- Keywords
- prediabetes, Tai Chi, Pilates, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Collaborators
- Hasan Kalyoncu University
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Individuals will be divided into 3 groups: Clinical Pilates group, Tai Chi group and Control group. 3 groups. 3 groups will be measured at the same time and then the exercise part will begin.
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: Pilates Exercises GroupIndividuals 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. |
| Tai Chi Group | Experimental | Other: Tai Chi Exercises GroupIndividuals 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates Exercises GroupIndividuals 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. | Other | Pilates Group |
| Tai Chi Exercises GroupIndividuals 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. | Other | Tai Chi Group |
Primary outcome
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.
Body Composition
Time frame: 2024-2025
In our study, the body composition of the participants will be evaluated using the Bioelectrical Impedance Device.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercises Group and Tai Chi Exercises Group in people with PreDiabetes, run by Nigde Omer Halisdemir University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gül PEHLİVAN TEKİN, Lecturer (0388 211 28 60 ext. 2871, gulpehlivantekin@ohu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glisemic Control (time frame: 2024- 2025). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.