Comparison Effects Of Different Exercise Approaches On Type 2 DM Women

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Video Based Home Exercise Program; Behavioral: Blue Prescription Exercise Program; Behavioral: Supervised Group Exercise Program

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İstanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Between 25-65 years of age
2. Having Type 2 DM for at least 5 years
3. HbA1c value> 6.5% / Fasting blood glucose> 126 mg / dl
4. Ability to walk independently
5. Volunteering to participate in research

Exclusion Criteria:

1. Type 1 DM
2. Using insulin
3. Orthopedic and neurological diseases that prevent exercise
4. Having cardiovascular, pulmonary and systemic diseases in which exercise is contraindicated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blue Prescription Group; 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.	Behavioral: Blue Prescription Exercise Program; 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.
Active Comparator: Video Based Home Exercise Group; 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.	Behavioral: Video Based Home Exercise Program; 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.
Active Comparator: Supervised Exercise Group; 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.	Behavioral: Supervised Group Exercise Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	In the beginning of the intervention and at the end of the exercise program (12 weeks).
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%.	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.	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.	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.	Change from Baseline 6-minute Walking Test Results at 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.	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.	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).	In the beginning of the intervention and at the end of the exercise program (12 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	It will be measured with a standard weighing instrument.	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.	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.	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	In the beginning of the intervention and at the end of the exercise program (12 weeks).
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.	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	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.	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.	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.	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	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.	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.	In the beginning of the intervention
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	In the beginning of the intervention and at the end of the exercise program (12 weeks).

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 10840098-604.01.01-E.14291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No