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Prediabetic StateNCT06452940

Effects of Clinical Pilates Exercises on Glycemic Control, Blood Lipids and Physical Fitness Parameters in Prediabetes

A study testing Exercise in people with Prediabetic State, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Prediabetic State
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2024to 15 Mar 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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Eastern Mediterranean University

    Mersin, Famagusta, 99450

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Clinical Pilates Exercises on Glycemic Control, Blood Lipids and Physical Fitness Parameters in Individuals With Prediabetes: Controlled Study

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.

Read the detailed description

Prediabetes refers to the middle stage of dysglycemia in the process from normoglycemia to diabetes. It is diagnosed by laboratory measurement of fasting blood glucose, glycosylated hemoglobin or blood glucose 2 hours after loading.

The increasing prevalence of prediabetes worldwide is an important public health problem. However, active recognition and treatment of prediabetes has lagged because clinicians do not see it as a disease state that needs to be addressed. Low levels of physical activity and physical fitness (both cardiovascular and musculoskeletal) are significant, independent and modifiable risk factors for the development of type 2 diabetes, and lifestyle changes, including exercise training, now represent a central strategy in diabetes prevention.

Hypotheses:

H1: Clinical pilates training given to individuals with prediabetes has no effect on glycemic control.

H2: Clinical pilates training given to individuals with prediabetes has no effect on blood lipids.

H3: Clinical pilates training given to individuals with prediabetes has no effect on physical fitness parameters.

H4: Clinical pilates training given to individuals with prediabetes has no effect on exercise beliefs.

Material and Method:

The study will be conducted on subjects diagnosed with prediabetes by specialist physician.Subjects who meet the inclusion and exclusion criteria and sign the informed consent form will be randomly divided into two different groups by random allocation program.

According to the power analysis made using the G-Power program; Assuming that the nonparametric ANOVA test will be used for the comparison between the 2 groups, and a total of 42 people will be included in the calculation made by taking Cohen d=0.40, α=0.05, β=0.20, 21 in each group.

Subjects will be divided into two groups through randomization. Randomization will be done with random allocation software program. Both groups will be informed about ways to prevent diabetes. Subjects in group 1 will continue their routine for 16 weeks. Subjects in the 2nd group will be given clinical pilates exercise training. Exercise training will continue for 16 weeks. Clinical pilates exercises will be 3 days a week. All participants will be evaluated before treatment, and 16 weeks.

Evaluations to be applied to the Subject:

Socio-demographic Form: Age, gender, height, body weight, dominant side, marital status, educational status, occupation, diseases in the past and family history, alcohol and cigarette consumption, year of prediabetes diagnosis, medication use, and history of surgery will be questioned from the individuals who will participate in the study.

Body composition measurement:

With bioelectrical impedance analyzer; Weight, body fat percentage, total body water, fat mass, lean body mass will be measured. Additionally, waist and hip circumferences will be measured with a tape measure and the waist/hip ratio will be calculated.

Biochemical tests:

People's HbA1c, fasting glucose, fasting insulin, HOMA-IR, HDL, LDL, vitamin D, Triglyceride and total cholesterol values will be questioned based on blood analyzes performed during routine doctor's checks.

Muscle strength measurement:

Grip strength will be measured with a hand-grip dynamometer. The patient will be asked to sit with an upright back and grasp and squeeze the dynamometer with the dominant side hand. The best value will be recorded by repeating three times.

Muscle strength of the upper and lower extremity muscles will be measured using a digital hand-held dynamometer. In order to ensure that the movement is revealed correctly in the measurements, the individuals will be asked to perform submaximal contraction against the hand of the evaluator and the evaluation will be started after the test trial is performed. The best value will be recorded after three repetitions.

Evaluation of Functional Strength of Core Muscles:

Sit-ups and Modified Push-ups tests will be performed. Measurements will be made using a stopwatch and the number of repetitions performed by individuals within 30 seconds will be recorded.

Endurance Assessment A 30-second sit and stand test will be performed to assess lower extremity endurance. McGill protocol will be applied to assess core endurance. This protocol includes trunk flexion, lateral bridge, modified "Biering-sorensen", prone bridge tests.

30 Second Sit and Stand Test: The participant will be asked to sit on a chair with a backrest and cross their arms over their shoulders. Then he/she will be told to sit up and get up from the chair with our start command, keeping the time for 30 seconds. The number of sit-ups during this time will be recorded.

Trunk Flexion Test: The trunk will be flexed 60°, knees and hips will be flexed 90°. The arms will be crossed over the chest and the participants will be asked to maintain this position for as long as possible.

Lateral Bridge Test: It will be performed lying on the mat on the side. Participants will be asked to lift their hips upwards and maintain this position.

Modified "Biering-sorensen" Test: It will be performed in prone position on the treatment table. The pelvis, hips and knees will be fixed on the treatment table up to the level of the spina iliaca anterior superior. Participants will be asked to maintain the body position for as long as possible by crossing their arms across the chest.

Prone Bridge Test: Participants will be asked to lift their torso upwards by placing their weight on their forearms and toes in a prone, elbow flexion position. Tests will be terminated when positions are disrupted. Measurement results will be recorded in seconds.

Flexibility Assessment:

Sit-Reach Test and Lateral Flexion Test will be performed. Sit-Reach Test: In the test, a ruler will be placed on a cube with a side of 30 cm. The participant will be asked to rest the sole of his/her foot on the cube in a long sitting position and reach out on the ruler with both hands and knees in extension. The edge of the cube will be taken as 0 and values above it will be taken as positive and values below it will be taken as negative. The test will be repeated three times and the highest value will be recorded.

Lateral Flexion Test: While the participant stands with arms straight next to the trunk, the 3rd fingertip projection on both sides will be marked on the body. The participant will be asked to tilt the body to one side first and the projection of the 3rd fingertip will be marked and the distance between the first projection will be noted in cm. Measurements will be made on both sides.

Balance Assessment:

Fullerton advanced balance (FAB-T) scale will be used. The FAB-T is a scale designed to assess changes in different dimensions of balance. The performance-based FAB-T scale consists of 10 items assessing functional balance (static and dynamic) status. Each test is scored between 0-4, with a maximum score of 40 and a minimum score of 0. A higher score represents better balance.

Exercise Beliefs Assessment:

Exercise will be evaluated with the benefits/obstacles scale. The Turkish validity and reliability of the scale was conducted by Ortabağ et al. The scale, which has a Cronbach's alpha coefficient of 0.95, is a 4-point Likert-type scale and is answered from 4 (strongly agree) to 1 (strongly disagree). Consisting of 43 questions, the total score of the scale is between 43-172. It has two sub-dimensions as Exercise Benefit Scale and Exercise Barrier Scale. Each sub-dimension can be evaluated separately. The total score of the benefit scale is between 29-116 and the total score of the barrier scale is between 14-56. A high total score on the Exercise Benefit Scale indicates that the individual has a good perception of exercise benefit, while a high total score on the Exercise Barrier Scale indicates that the individual has a high perception of exercise barrier.

All assessments will be made before treatment, and week 16.

Interventions:

  1. Group (Control): Subjects will continue their routine.
  2. Group (Clinical Pilates Exercises): 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.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 the exercises are; breathing, centering, rib cage placement, shoulder placement, head and neck placement will be taught. Exercises will start with 10 repetitions and will be gradually increased in 3-week periods.
Being tested
Exercise
Keywords
Prediabetics, Exercise, Glycemic Control, Blood Glucose
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.

  • ExerciseOther

    Also called Clinical pilates

    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.

Study groups in NCT06452940
Study groupRoleWhat they receive
Control GroupNo interventionDiabetes 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 GroupExperimentalDiabetes 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.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at baseline and at the end of the 16th week

Secondary outcomes (20)
  1. Fasting Blood Glucose

    The expected values for normal fasting blood glucose concentration are between 70 mg/dL (3.9 mmol/L) and 100 mg/dL (5.6 mmol/L). When fasting blood glucose is between 100 to 125 mg/dL (5.6 to 6.9 mmol/L) changes in lifestyle and monitoring glycemia are recommended.

    Measured: at baseline and at the end of the 16th week

  2. Fasting insulin

    Fasting insulin value will be checked based on blood analyses performed during routine doctor controls.

    Measured: at baseline and at the end of the 16th week

  3. HOMA-IR

    HOMA-IR value will be checked based on blood analyses performed during routine doctor controls.

    Measured: at baseline and at the end of the 16th week

  4. HDL, LDL

    values will be checked based on blood analyses performed during routine doctor controls.

    Measured: at baseline and at the end of the 16th week

  5. Vitamin D

    Vitamin D, value will be checked based on blood analyses performed during routine doctor controls.

    Measured: at baseline and at the end of the 16th week

  6. Triglyceride

    Triglyceride, value will be checked based on blood analyses performed during routine doctor controls.

    Measured: at baseline and at the end of the 16th week

  7. Total cholesterol

    Total cholesterol, value will be checked based on blood analyses performed during routine doctor controls.

    Measured: at baseline and at the end of the 16th week

  8. Body composition measurement

    Weight, body fat percentage, total body water, fat mass, fat mass, lean body mass will be measured with a bioelectrical impedance analyzer.

    Measured: at baseline and at the end of the 16th week

  9. Waist-hip ratio

    Waist and hip circumference will be measured with a tape measure and waist/hip ratio will be calculated.

    Measured: at baseline and at the end of the 16th week

  10. Grip Strength

    Grip strength will be measured with a hand-grip dynamometer. The patient will be asked to sit with his/her back straight and grasp and squeeze the dynamometer with the dominant side hand. The best value will be recorded by repeating three times

    Measured: at baseline and at the end of the 16th week

  11. Muscle Strength

    Muscle strength of the upper and lower extremity muscles will be measured using a digital hand-held dynamometer. In order to ensure that the movement is correctly revealed in the measurements, the individuals will be asked to perform submaximal contraction against the evaluator's hand and the evaluation will be started after the test trial is performed. The best value will be recorded after three repetitions

    Measured: at baseline and at the end of the 16th week

  12. Functional Strength of Core Muscles

    Sit-ups and modified push-up tests will be performed. Measurements will be made using a stopwatch and the number of repetitions performed by individuals within 30 seconds will be recorded

    Measured: at baseline and at the end of the 16th week

  13. Sit-up Test

    Sit-up tests will be performed for the functional strength of core muscles. Measurements will be made using a stopwatch and the number of repetitions performed by individuals within 30 seconds will be recorded

    Measured: at baseline and at the end of the 16th week

  14. Modified push-up Test

    Modified push-up tests will be performed for functional strength of core muscles. Measurements will be made using a stopwatch and the number of repetitions performed by individuals within 30 seconds will be recorded

    Measured: at baseline and at the end of the 16th week

  15. Lower Extremity Endurance

    A 30-second sit and stand test will be performed to assess lower extremity endurance.

    McGill protocol will be applied to evaluate core endurance. This protocol includes trunk flexion, lateral bridge, modified "Biering-sorensen", prone bridge tests.Tests will be terminated when the positions are disturbed. The measurement results will be recorded in seconds.

    Measured: at baseline and at the end of the 16th week

  16. Core Endurance

    McGill protocol will be applied to evaluate core endurance. This protocol includes trunk flexion, lateral bridge, modified "Biering-sorensen", prone bridge tests.Tests will be terminated when the positions are disturbed. The measurement results will be recorded in seconds.

    Measured: at baseline and at the end of the 16th week

  17. Sit-Reach Test

    SRT will be performed for flexibility. The test will be repeated three times and the highest value will be recorded.

    Measured: at baseline and at the end of the 16th week

  18. Lateral Flexion Test

    LFT will be performed for flexibility.The test will be repeated three times and the highest value will be recorded.

    Measured: at baseline and at the end of the 16th week

  19. Balance

    The Fullerton advanced balance (FAB-T) scale will be used.

    Measured: at baseline and at the end of the 16th week

  20. Exercise Beliefs

    Exercise beliefs will be assessed with the exercise benefits/barriers scale.

    Measured: at baseline and at the end of the 16th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start15 May 2024
  3. Primary completion15 Sep 2024
  4. Study completion15 Mar 2025

Resources

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
Masking
Single blind
Who is masked
Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06452940
Sponsor's protocol ID
AKaraman
Status last verified
Apr 2025
First submitted
16 May 2024
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

  • 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.

    PubMed 33355476

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Prediabetic State, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

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 5 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: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The glycosylated hemoglobin A1c (time frame: at baseline and at the end of the 16th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06452940, which also lists 2 linked publications.

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 23 Apr 2025.

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