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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
Other: 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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nigde Omer Halisdemir University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hasan Kalyoncu University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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