Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452940
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-16
Brief Title:
Effects of Clinical Pilates Exercises on Glycemic Control Blood Lipids and Physical Fitness Parameters in Prediabetes
Sponsor:
Eastern Mediterranean University
Organization:
Eastern Mediterranean University
Study Overview
Official Title:
Effects of Clinical Pilates Exercises on Glycemic Control Blood Lipids and Physical Fitness Parameters in Individuals With Prediabetes Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 randomizationSubjects 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
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 physicianSubjects 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 d040 α005 β020 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 waisthip ratio will be calculated
Biochemical tests
Peoples 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 doctors 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 heshe 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 hisher 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 benefitsobstacles scale The Turkish validity and reliability of the scale was conducted by Ortabağ et al The scale which has a Cronbachs alpha coefficient of 095 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 periodBefore 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
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 physicianSubjects 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 d040 α005 β020 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 waisthip ratio will be calculated
Biochemical tests
Peoples 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 doctors 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 heshe 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 hisher 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 benefitsobstacles scale The Turkish validity and reliability of the scale was conducted by Ortabağ et al The scale which has a Cronbachs alpha coefficient of 095 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 periodBefore 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None