NCT06343025

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 27, 2024

Last Update Submit

March 27, 2024

Conditions

Keywords

prediabetesTai ChiPilatesExercise

Outcome Measures

Primary Outcomes (4)

  • 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

  • Body Composition

    In our study, the body composition of the participants will be evaluated using the Bioelectrical Impedance Device.

    2024-2025

  • Balance

    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

    In our study, the International Physical Activity Scale (IPAQ) and Accelerometer will be used to determine the physical activity level.

    2024-2025

Study Arms (3)

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.

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.

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.

Interventions

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.

Pilates 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.

Tai Chi Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prediabetic StateMotor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Central Study Contacts

Gül PEHLİVAN TEKİN, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes ,Assesor, who will make the evaluations in the first week and after 12 weeks, will not know which group the people are in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 2, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

April 2, 2024

Record last verified: 2024-03