NCT06452940

Brief Summary

To examine the effects of clinical pilates exercise on glycemic control, blood lipids and physical fitness parameters in prediabetics. Subjects will be divided into two groups through randomization.Subjects in the 1st group will be included in the control group and will continue their routine. Subjects in the 2nd group will be given clinical pilates exercise training. All subjects will be evaluated at the start of treatment, and week 16.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 15, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 16, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

May 16, 2024

Last Update Submit

April 18, 2025

Conditions

Keywords

PrediabeticsExerciseGlycemic ControlBlood Glucose

Outcome Measures

Primary Outcomes (1)

  • The glycosylated hemoglobin A1c

    An A1C test result reflects your average blood sugar level for the past two to three months. Specifically, the A1C test measures what percentage of hemoglobin proteins in your blood are coated with sugar (glycated). Hemoglobin proteins in red blood cells transport oxygen. The higher your A1C level is, the poorer your blood sugar control and the higher your risk of diabetes complications.

    at baseline and at the end of the 16th week

Secondary Outcomes (20)

  • Fasting Blood Glucose

    at baseline and at the end of the 16th week

  • Fasting insulin

    at baseline and at the end of the 16th week

  • HOMA-IR

    at baseline and at the end of the 16th week

  • HDL, LDL

    at baseline and at the end of the 16th week

  • Vitamin D

    at baseline and at the end of the 16th week

  • +15 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Diabetes education will be given at the beginning and ways to prevent type 2 diabetes will be explained.Evaluation will be made at the beginning and at the end of 16 weeks.

Exercise Group

EXPERIMENTAL

Diabetes education will be given at the beginning and ways to prevent type 2 diabetes will be explained.Clinical pilates exercises will be performed.It will consist of a warm-up, main exercise and a cool-down period.Exercises will start with 10 repetitions and will be gradually increased in 3-week periods.Before the exercise training begins, all participants will be informed about clinical pilates and its basic principles will be explained. In the first session; The 5 key elements of pilates that should not be disrupted during exercises are; breathing, centering, rib cage placement, shoulder placement, head and neck placement will be taught. Exercise program will be done 3 days a week for 16 weeks.

Other: Exercise

Interventions

A 16-week clinical pilates exercise program will be applied 3 days a week for 60 minutes each session. It will consist of a warm-up, main exercise and a cool-down period.Exercises will start with 10 repetitions and will be gradually increased in 3-week periods.

Also known as: Clinical pilates
Exercise Group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being diagnosed with Prediabetes
  • Being between the ages of 30-60
  • Not having received physiotherapy in the last 6 months
  • Being physically inactive (\<150 min/week or \<600 MET/week according to the International Physical Activity Survey Short Version)

You may not qualify if:

  • Having a history of type 2 diabetes
  • Taking any supplements to maintain weight control
  • Having a history of acute trauma affecting the movement system within the last month
  • Presence of orthopedic/neurological/cardiopulmonary disease affecting the movement system
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Mersin, Famagusta, 99450, Turkey (Türkiye)

Location

Related Publications (2)

  • ADA(Am.DiabetesAssoc.).2020.2.Classificationanddiagnosisofdiabetes:StandardsofMedicalCare in Diabetes-2020. Diabetes Care 43(Suppl. 1):S14-31

    BACKGROUND
  • Echouffo-Tcheugui JB, Selvin E. Prediabetes and What It Means: The Epidemiological Evidence. Annu Rev Public Health. 2021 Apr 1;42:59-77. doi: 10.1146/annurev-publhealth-090419-102644. Epub 2021 Dec 23.

    PMID: 33355476BACKGROUND

MeSH Terms

Conditions

Prediabetic StateMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ayşen Karaman, MSc

    EMU

    PRINCIPAL INVESTIGATOR
  • Ender Angın, PhD

    EMU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2024

First Posted

June 11, 2024

Study Start

May 15, 2024

Primary Completion

September 15, 2024

Study Completion

March 15, 2025

Last Updated

April 23, 2025

Record last verified: 2025-04

Locations