Type 2 DiabetesNCT05479435
Comparison Effects Of Different Exercise Approaches On Type 2 DM Women
A study testing Blue Prescription Exercise Program, Video Based Home Exercise Program and Supervised Group Exercise Program in people with Type 2 Diabetes, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic diseases with a complex, multifactorial etiology, and is a chronic disease with various clinical and biochemical manifestations. It has been known for a long time that T2DM treatments include medication, diet, and exercise. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Blue Prescription Exercise Program, Video Based Home Exercise Program and Supervised Group Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 25-65 years of age
- Having Type 2 DM for at least 5 years
- HbA1c value> 6.5% / Fasting blood glucose> 126 mg / dl
- Ability to walk independently
- Volunteering to participate in research
Who cannot join
- Type 1 DM
- Using insulin
- Orthopedic and neurological diseases that prevent exercise
- Having cardiovascular, pulmonary and systemic diseases in which exercise is contraindicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Effects Of Blue Prescription Program, Home Exercise Program And Supervised Exercise Approaches On Type 2 Diabetic Women
Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic diseases with a complex, multifactorial etiology, and is a chronic disease with various clinical and biochemical manifestations. It has been known for a long time that T2DM treatments include medication, diet, and exercise. Exercise can improve blood glucose control, increase insulin sensitivity, respiratory capacity, well-being and cognitive functions, regulate lipid profile, blood pressure, reduce cardiovascular disease risk, abdominal obesity, weight. Although there are many studies in the literature on the effects of exercise in T2DM, there is no consensus on which exercise protocol is more effective. In the studies, the obstacles in front of the diabetic patients' adaptation to exercise; laziness, lack of motivation and energy, embarrassment from family and social environment, lack of support, time constraints, financial problems, lack of space to exercise, fear of hypoglycaemia, pain, stiffness, fatigue, shortness of breath, presence of additional diseases, fear of injury. Blue Prescription (BP) is a model developed to facilitate the participation in physical activity. In traditional home programs, patients are told what to do. The BP approach, on the other hand, involves providing the person with options for physical activity, removing the barriers to activity instead of the classical home exercise program or physical activity counselling, and being in communicate according to the person's preferences during this process. This approach has been developed to facilitate participation in physical activity and to ensure the sustainability of physical activity in individuals with chronic diseases. Philosophy of the approach aims to increase the activity level gradually, improve the quality of life and participation in the activity with motivational interview, continuous support, communication and activity diary, instead of recommending physical activity with classical methods due to the different needs, desires and preferences of people. Studies using the BP in the literature have focused on Multiple Sclerosis and stroke, and no publications on other chronic diseases have been found. The aim of this study is to examine the effects of BP, video-based home exercise and supervised group exercises on HbA1c, physical activity level, functional capacity and other metabolic control variables in primary care women with T2DM.
- Conditions
- Type 2 Diabetes
- Being tested
- Blue Prescription Exercise Program, Video Based Home Exercise Program, Supervised Group Exercise Program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue Prescription Exercise ProgramBehavioural
After the evaluation, participants will receive feedback and physical activity training, along with an explanation of the benefits of exercise, provided in the form of a brochure. They will then be enrolled in the Blue Prescription program, which includes weekly follow-ups for 12 weeks and a re-evaluation at the end of the 12th week. Motivation and support will be offered in accordance with the Blue Prescription philosophy, addressing home exercise programs, physical activity selection, and overcoming obstacles. Participants will be encouraged to determine the most suitable program for themselves and maintain an activity diary.
Throughout the study, participants will have the opportunity to communicate with the physiotherapist via various methods such as phone, SMS, or email.
Video Based Home Exercise ProgramBehavioural
After the evaluation, DM and physical activity training will be given, the benefits of exercise will be explained and these will be given as a brochure. A video exercise program will be given in the format and method desired by the participant. It will be evaluated again at the end of the 12th week.
Supervised Group Exercise ProgramBehavioural
DM and physical activity training will be given after the assessment, the benefits of the exercise will be explained and these will be given as a brochure. Participants will engage in exercises with a physiotherapist three days a week for 12 weeks, and the effectiveness of the program will be re-evaluated at the end of the 12th week.
| Study group | Role | What they receive |
|---|---|---|
| Blue Prescription Group | Experimental | Participants will receive an exercise program designed according to their needs, desires, and abilities. They will perform the desired exercise program three days a week and will have an interview for motivation and/or modifying the program one day a week. They will also keep an activity diary. Receives: Behavioral: Blue Prescription Exercise Program |
| Video Based Home Exercise Group | Active comparator | Participants will receive videos through various channels. They will perform exercises three days a week. The investigator will call them to inquire whether they are following the program or not. Additionally, they will keep an activity diary. Receives: Behavioral: Video Based Home Exercise Program |
| Supervised Exercise Group | Active comparator | Participants will perform an exercise program 3 days a week under the guidance of a physiotherapist. Each group will consist of a maximum of 10 people. Receives: Behavioral: Supervised Group Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Hemoglobin Change
Hemoglobin A1c is a blood test used to measure the effectiveness of treatment in diabetes, and sometimes to diagnose diabetes. The generally accepted reference range for Hemoglobin A1c (HbA1c) is between 4% and 6%.
Measured: Change from Baseline Glycosylated Hemoglobin at 12 weeks.
Physical Activity Level Change
The questionnaire provides information about the time spent by the individual in light, moderate, and vigorous activities and sitting in the last 7 days. The MET-min / week score is obtained by multiplying the MET value (metabolic equivalent) by days and minutes for each activity level. Physical activity levels are classified as:
Physically inactive (<600 MET-min / week), Low physical activity (600-3000 MET-min / week), and Adequate physical activity (> 3000 MET-min / week). A higher score is associated with a higher physical activity level.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks)
Functional Capacity Change With Timed Up And Go Test
The participant will sit on a chair without armrests, stand up with the command to start, walk 3 meters towards the designated point, turn around and walk to the starting point again and sit. The test is repeated 3 times and the average is taken. The time will be recorded in seconds. As time increases, the risk of falling increases.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks)
Functional Capacity Change With 6-minute Walking Test
It will be performed in a 30 meter long corridor or in an open area. The participant will be asked to walk without running at the highest speed for 6 minutes. Before and during the march, the participant will be verbally encouraged and motivated. How many meters they walked will be recorded as a result of the test. Six-minute walk test results can be interpreted as follows:
Normal: more than 500 meters Light restriction: 400 to 500 meters Moderate restriction: 300 to 400 meters Severe restriction: between 200 - 300 meters Serious restriction: less than 200 meters.
Measured: Change from Baseline 6-minute Walking Test Results at 12 weeks.
Fasting Plasma Glucose
Measured level of glucose in the blood after 8 to 12 hours of fasting. The unit of measurement is mg/dL, the reference range is 70-110 mg/dL.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
High Density Lipoprotein
It takes part in the transport of cholesterol from tissues and vessels to the liver and in the synthesis of vitamin D. The unit of measurement is mg/dL, the reference range is 30-96 mg/dL.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Low Density Lipoprotein
It provides the transport of cholesterol synthesized in the liver to the tissues and blood vessels. The unit of measurement is mg/dL, the reference range is 0- 130 mg/dL.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Total Cholesterol
Total cholesterol is a value that shows the total amount of cholesterol in the blood. In addition to LDL and HDL, triglyceride levels are also used to calculate total cholesterol. The unit of measurement is mg/dL, the reference range is 70-200 mg/dL.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Triglyceride
It is a storage nutrient molecule formed by the combination of fatty acids and glycerol molecules, which form the structure of fats in foods. The unit of measurement is mg/dL, the reference range is 0-250 mg/dL.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
C-reactive Protein
It is a protein produced in the liver. It is a protein that is produced by cells and secreted into the blood when the body reacts to conditions such as infection, tumor, trauma, and undertakes various biochemical tasks. The unit of measurement is mg/dL, the reference range is 0-0.5 mg/dL.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Systolic Blood Pressure
Blood pressure is the pressure that builds up in the blood vessels when the heart contracts. It is measured with a sphygmomanometer. The cuff is placed 2.5 to 3 cm above the inside of the elbow. The stethoscope is placed under the cuff and pressed lightly. The sphygmomanometer cuff is then inflated to 20 to 30 mmHg above the level at which the pulse disappears. The control valve should be opened slightly, and air should be vented at a rate of 2-4 mmHg per second. The first sound heard as the air is released determines the systolic blood pressure. The reference range averages 120 - 130 mmHg.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Diastolic Blood Pressure
The pressure that builds up in the blood vessels as the heart relaxes is known as diastolic blood pressure. It is measured using a sphygmomanometer, which is placed 2.5 to 3 cm above the inside of the elbow. The stethoscope is placed under the cuff and lightly pressed. The sphygmomanometer cuff is then inflated to 20 to 30 mmHg above the point where the pulse disappears. The control valve should be opened slightly, and air should be released at a rate of 2-4 mmHg per second. The point at which the sound becomes inaudible is considered the diastolic blood pressure. The reference range averages 70 - 90 mmHg.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Heart Rate
It is the value that shows how many times the heart beats in a minute. Measurement from the wrist: measured from the radial artery with 3 fingers with the palm facing up. The reference range is between 60 and 100 beats per minute (bpm).
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Secondary outcomes (13)
Body Fat Ratio Change With Bioelectrical Impedance Analysis (BIA)
-Bioelectrical Impedance Analysis (BIA): The basic principle is to measure the impedance by using the resistance and conductivity that a very small amount of electrical current encounters when passing through tissues. Reference values for Bioelectrical Impedance Analysis (BIA) may vary depending on factors such as age, gender, height and weight. However, a typical BIA reference range for generally healthy adults is as follows:
Body Fat Percentage:
For women: 20% - 25%
Body Mass Index (BMI):
Normal Range: 18.5 - 24.9 kg/m² However, these values can vary greatly between individuals and may vary depending on many factors such as clinical conditions, lifestyle factors, ethnicity, etc. Therefore, BIA results should be interpreted taking into account the individual's personal health status and goals. "Tanita SC-330" brand device will be used in our study.
Measured: Change from Baseline Bioelectrical Impedance Analysis at 12 weeks.
Body Fat Ratio Change With Skinfold Analysis
All measurements will be made on the right side of the body. The caliper will be placed approximately 1 cm from the thumb and index finger, and 1-2 seconds will be waited before the caliper is read. Body fat percentages of individuals will be calculated using Jackson-Pollock 7 region equations; Triceps, Subscapularis, Midaxillary, Abdominal, Chest, Suprailiac. The Jackson-Pollock skinfold thickness method is a method used to estimate body fat percentage. Reference values may vary depending on factors such as the person's gender, age range and lifestyle. However, in general, reference values for body fat percentage obtained using the Jackson-Pollock formula are as follows:
Athletic women: 14-20% Women in good shape: 21-24% Average women: 25-31% Overweight women: 32-39% Obese women: 40% and above
Measured: Change from Baseline Skinfold Analysis at 12 weeks.
Flexibility Change With Fingertip-to-floor Distance Measure
During the test, the participant will be asked to lean forward without bending their knees and try to touch the fingertip. The distance between the tip of the third finger of the hand and the ground will be measured and the result will be recorded in cm. This distance is considered normal up to 0 cm in women and up to 10 cm in men.
Measured: Change from Baseline Fingertip-to-floor Distance Measure at 12 weeks.
Flexibility Change With Trunk Lateral Flexion Measure
The participant will be asked to stand with their feet slightly open, parallel to each other, arms next to the trunk. Mark the distal end of the third finger of the hand on the thigh, and the participant will be asked to perform lateral flexion. The point where the distal of the third finger comes from is marked again. The distance between the two points is cm. will be recorded in terms. A higher value is associated with good flexibility.
Measured: Change from Baseline Trunk Lateral Flexion Measure at 12 weeks.
Life Quality
The Diabetes Quality of Life (DQoL) Questionnaire consists of 46 items divided into four subscales: Satisfaction (15 items), Impact (20 items), Worry - Social/Vocational (7 items), and Worry - Diabetes-Related (4 items). Each item is rated on a 5-point Likert scale ranging from 1 to 5. Depending on the item, higher scores may indicate either greater dissatisfaction, greater impact, or higher worry. Subscale scores are calculated by summing item responses within each subscale. The total score is the sum of all items and ranges from 46 to 230. Higher total scores indicate a lower diabetes-related quality of life.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Depression
It will be evaluated with the Beck Depression Scale. The scale is used to measure the level of depression with a 21-item multiple-choice question. Each question is evaluated within a certain score range, and the total score shows the person's depression level. However, the scale does not have an official "reference" range because scoring may vary depending on clinical or research purposes.
In general, Beck Depression Inventory (BDI) scores can be interpreted as follows:
0-13 points: Mild or minimal depression 14-19 points: Mild depression 20-28 points: Moderate depression 29-63 points: Severe depression
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Contentment
It will be evaluated with The Diabetes Treatment Satisfaction Questionnaire (DTSQ). The questionnaire measures how the individual perceives glycemic control and satisfaction with the treatment. Suitable for Type 1 DM and Type 2 DM. It consists of 8 items and is scored on a 0-6 Likert scale. 6 items 1, 4, 5, 6, 7, 8); It meets to determine satisfaction between 0 (not at all) and 6 (very satisfied). Of the remaining items, 2, 0 (never) to 6 almost always) measure the frequency of detection of hyperglycemia, and item 3 measures the frequency of detecting hypoglycemia. The highest score is calculated as 36. High scores indicate satisfaction with treatment, while low scores indicate dissatisfaction.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Height
It will be measured with a stadiometer. Head, shoulders, back, hips, calves and heels will touch the stadiometer, stand upright with feet shoulder-width apart, slide of height meter will be pulled down.
Measured: In the beginning of the intervention
Weight
It will be measured with a standard weighing instrument.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Neck Circumference
In the anatomical position, the tape measure is measured just below the thyroid cartilage.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Waist Circumference
It is measured at the thinnest point between the lowest rib and anterior superior to the processus spina ilica in the anatomical position.
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Hip Circumference
Measured at the widest point of the Gluteus Maximus muscle in the anatomical position
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Body Mass Index (BMI)
BMI will be calculated by dividing body weight (kg) by height square (m^2). General reference ranges for BMI are as follows:
If BMI is less than 18.5 kg/m^2: Underweight If BMI is between 18.5-24.9 kg/m^2: Normal weight If BMI is between 25.0-29.9 kg/m^2: Overweight If BMI is 30.0 kg/m^2 and above: Obese
Measured: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Sep 2021
- Primary completion1 Mar 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial with statistic analyst blind
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aabalay, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479435
- Sponsor's protocol ID
- 10840098-604.01.01-E.14291
- Status last verified
- May 2025
- First submitted
- 26 Jan 2022
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Effects Of Blue Prescription Program, Home Exercise Program And Supervised Exercise Approaches On Type 2 Diabetic Women
- ClinicalTrials.gov ID
- NCT05479435
- Acronym / sponsor ID
- 10840098-604.01.01-E.14291
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic diseases with a complex, multifactorial etiology, and is a chronic disease with various clinical and biochemical manifestations. It has been known for a long time that T2DM treatments include medication, diet, and exercise. Exercise can improve blood glucose control, increase insulin sensitivity, respiratory capacity, well-being and cognitive functions, regulate lipid profile, blood pressure, reduce cardiovascular disease risk, abdominal obesity, weight. Although there are many studies in the literature on the effects of exercise in T2DM, there is no consensus on which exercise protocol is more effective. In the studies, the obstacles in front of the diabetic patients' adaptation to exercise; laziness, lack of motivation and energy, embarrassment from family and social environment, lack of support, time constraints, financial problems, lack of space to exercise, fear of hypoglycaemia, pain, stiffness, fatigue, shortness of breath, presence of additional diseases, fear of injury. Blue Prescription (BP) is a model developed to facilitate the participation in physical activity. In traditional home programs, patients are told what to do. The BP approach, on the other hand, involves providing the person with options for physical activity, removing the barriers to activity instead of the classical home exercise program or physical activity counselling, and being in communicate according to the person's preferences during this process. This approach has been developed to facilitate participation in physical activity and to ensure the sustainability of physical activity in individuals with chronic diseases. Philosophy of the approach aims to increase the activity level gradually, improve the quality of life and participation in the activity with motivational interview, continuous support, communication and activity diary, instead of recommending physical activity with classical methods due to the different needs, desires and preferences of people. Studies using the BP in the literature have focused on Multiple Sclerosis and stroke, and no publications on other chronic diseases have been found. The aim of this study is to examine the effects of BP, video-based home exercise and supervised group exercises on HbA1c, physical activity level, functional capacity and other metabolic control variables in primary care women with T2DM.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized control trial with statistic analyst blind
| Arm | Type | Receives |
|---|---|---|
| Blue Prescription Group | Experimental | Behavioral: Blue Prescription Exercise ProgramParticipants will receive an exercise program designed according to their needs, desires, and abilities. They will perform the desired exercise program three days a week and will have an interview for motivation and/or modifying the program one day a week. They will also keep an activity diary. |
| Video Based Home Exercise Group | Active comparator | Behavioral: Video Based Home Exercise ProgramParticipants will receive videos through various channels. They will perform exercises three days a week. The investigator will call them to inquire whether they are following the program or not. Additionally, they will keep an activity diary. |
| Supervised Exercise Group | Active comparator | Behavioral: Supervised Group Exercise ProgramParticipants will perform an exercise program 3 days a week under the guidance of a physiotherapist. Each group will consist of a maximum of 10 people. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 25-65 years of age
- Having Type 2 DM for at least 5 years
- HbA1c value> 6.5% / Fasting blood glucose> 126 mg / dl
- Ability to walk independently
- Volunteering to participate in research
Key exclusion criteria (4 listed)
- Type 1 DM
- Using insulin
- Orthopedic and neurological diseases that prevent exercise
- Having cardiovascular, pulmonary and systemic diseases in which exercise is contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue Prescription Exercise ProgramAfter the evaluation, participants will receive feedback and physical activity training, along with an explanation of the benefits of exercise, provided in the form of a brochure. They will then be enrolled in the Blue Prescription program, which includes weekly follow-ups for 12 weeks and a re-evaluation at the end of the 12th week. Motivation and support will be offered in accordance with the Blue Prescription philosophy, addressing home exercise programs, physical activity selection, and overcoming obstacles. Participants will be encouraged to determine the most suitable program for themselves and maintain an activity diary. Throughout the study, participants will have the opportunity to communicate with the physiotherapist via various methods such as phone, SMS, or email. | Behavioural | Blue Prescription Group |
| Video Based Home Exercise ProgramAfter the evaluation, DM and physical activity training will be given, the benefits of exercise will be explained and these will be given as a brochure. A video exercise program will be given in the format and method desired by the participant. It will be evaluated again at the end of the 12th week. | Behavioural | Video Based Home Exercise Group |
| Supervised Group Exercise ProgramDM and physical activity training will be given after the assessment, the benefits of the exercise will be explained and these will be given as a brochure. Participants will engage in exercises with a physiotherapist three days a week for 12 weeks, and the effectiveness of the program will be re-evaluated at the end of the 12th week. | Behavioural | Supervised Exercise Group |
Primary outcome
Glycosylated Hemoglobin Change
Time frame: Change from Baseline Glycosylated Hemoglobin at 12 weeks.
Hemoglobin A1c is a blood test used to measure the effectiveness of treatment in diabetes, and sometimes to diagnose diabetes. The generally accepted reference range for Hemoglobin A1c (HbA1c) is between 4% and 6%.
Physical Activity Level Change
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks)
The questionnaire provides information about the time spent by the individual in light, moderate, and vigorous activities and sitting in the last 7 days. The MET-min / week score is obtained by multiplying the MET value (metabolic equivalent) by days and minutes for each activity level. Physical activity levels are classified as: Physically inactive (<600 MET-min / week), Low physical activity (600-3000 MET-min / week), and Adequate physical activity (> 3000 MET-min / week). A higher score is associated with a higher physical activity level.
Functional Capacity Change With Timed Up And Go Test
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks)
The participant will sit on a chair without armrests, stand up with the command to start, walk 3 meters towards the designated point, turn around and walk to the starting point again and sit. The test is repeated 3 times and the average is taken. The time will be recorded in seconds. As time increases, the risk of falling increases.
Functional Capacity Change With 6-minute Walking Test
Time frame: Change from Baseline 6-minute Walking Test Results at 12 weeks.
It will be performed in a 30 meter long corridor or in an open area. The participant will be asked to walk without running at the highest speed for 6 minutes. Before and during the march, the participant will be verbally encouraged and motivated. How many meters they walked will be recorded as a result of the test. Six-minute walk test results can be interpreted as follows: Normal: more than 500 meters Light restriction: 400 to 500 meters Moderate restriction: 300 to 400 meters Severe restriction: between 200 - 300 meters Serious restriction: less than 200 meters.
Fasting Plasma Glucose
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Measured level of glucose in the blood after 8 to 12 hours of fasting. The unit of measurement is mg/dL, the reference range is 70-110 mg/dL.
High Density Lipoprotein
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
It takes part in the transport of cholesterol from tissues and vessels to the liver and in the synthesis of vitamin D. The unit of measurement is mg/dL, the reference range is 30-96 mg/dL.
Low Density Lipoprotein
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
It provides the transport of cholesterol synthesized in the liver to the tissues and blood vessels. The unit of measurement is mg/dL, the reference range is 0- 130 mg/dL.
Total Cholesterol
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Total cholesterol is a value that shows the total amount of cholesterol in the blood. In addition to LDL and HDL, triglyceride levels are also used to calculate total cholesterol. The unit of measurement is mg/dL, the reference range is 70-200 mg/dL.
Triglyceride
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
It is a storage nutrient molecule formed by the combination of fatty acids and glycerol molecules, which form the structure of fats in foods. The unit of measurement is mg/dL, the reference range is 0-250 mg/dL.
C-reactive Protein
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
It is a protein produced in the liver. It is a protein that is produced by cells and secreted into the blood when the body reacts to conditions such as infection, tumor, trauma, and undertakes various biochemical tasks. The unit of measurement is mg/dL, the reference range is 0-0.5 mg/dL.
Systolic Blood Pressure
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Blood pressure is the pressure that builds up in the blood vessels when the heart contracts. It is measured with a sphygmomanometer. The cuff is placed 2.5 to 3 cm above the inside of the elbow. The stethoscope is placed under the cuff and pressed lightly. The sphygmomanometer cuff is then inflated to 20 to 30 mmHg above the level at which the pulse disappears. The control valve should be opened slightly, and air should be vented at a rate of 2-4 mmHg per second. The first sound heard as the air is released determines the systolic blood pressure. The reference range averages 120 - 130 mmHg.
Diastolic Blood Pressure
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
The pressure that builds up in the blood vessels as the heart relaxes is known as diastolic blood pressure. It is measured using a sphygmomanometer, which is placed 2.5 to 3 cm above the inside of the elbow. The stethoscope is placed under the cuff and lightly pressed. The sphygmomanometer cuff is then inflated to 20 to 30 mmHg above the point where the pulse disappears. The control valve should be opened slightly, and air should be released at a rate of 2-4 mmHg per second. The point at which the sound becomes inaudible is considered the diastolic blood pressure. The reference range averages 70 - 90 mmHg.
Heart Rate
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
It is the value that shows how many times the heart beats in a minute. Measurement from the wrist: measured from the radial artery with 3 fingers with the palm facing up. The reference range is between 60 and 100 beats per minute (bpm).
13 secondary outcomes
Body Fat Ratio Change With Bioelectrical Impedance Analysis (BIA)
Time frame: Change from Baseline Bioelectrical Impedance Analysis at 12 weeks.
Body Fat Ratio Change With Skinfold Analysis
Time frame: Change from Baseline Skinfold Analysis at 12 weeks.
Flexibility Change With Fingertip-to-floor Distance Measure
Time frame: Change from Baseline Fingertip-to-floor Distance Measure at 12 weeks.
Flexibility Change With Trunk Lateral Flexion Measure
Time frame: Change from Baseline Trunk Lateral Flexion Measure at 12 weeks.
Life Quality
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Depression
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Contentment
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Height
Time frame: In the beginning of the intervention
Weight
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Neck Circumference
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Waist Circumference
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Hip Circumference
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Body Mass Index (BMI)
Time frame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue Prescription Exercise Program, Video Based Home Exercise Program and Supervised Group Exercise Program in people with Type 2 Diabetes, run by Istanbul Medipol University Hospital 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 5 inclusion and 4 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 12 Jun 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?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycosylated Hemoglobin Change (time frame: Change from Baseline Glycosylated Hemoglobin at 12 weeks.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2025.