Comparison Effects Of Different Exercise Approaches On Type 2 DM Women

Type 2 Diabetes Clinical Trial

Official title:

Comparison Effects Of Blue Prescription Program, Home Exercise Program And Supervised Exercise Approaches On Type 2 Diabetic Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479435
• Other study ID #: 10840098-604.01.01-E.14291
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Istanbul Medipol University Hospital
• Contact: Arzu Abalay, Msc
• Phone: +905075891917
• Email: arzuabalay[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic diseases with a complex, multifactorial aetiology, and is a chronic disease with various clinical and biochemical manifestations. It has been known for a long time that T2DM treatments are 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, timelessness, 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 continuous 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 communication with the way the person wants 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 continuous 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 tastes 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Blue Prescription 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. It will be followed up with the blue prescription program once a week for 12 weeks and will be re-evaluated at the end of the 12th week. Motivation and support will be provided according to the blue prescription philosophy, home exercise program, physical activity selection, obstacles to the activity are discussed, the participant will be asked to determine the appropriate program and keep an activity diary. Throughout the study, the participant will be able to communicate with the physiotherapist by any method (phone, SMS, email).
• 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.
• 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. Exercises will be done with a physiotherapist for 12 weeks 3 days a week and will be evaluated again at the end of the 12th week.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Hemoglobin Change	Hemoglobin A1c is a blood test used to measure the effectiveness of treatment in diabetes, and sometimes to diagnose diabetes.	Change from Baseline Glycosylated Hemoglobin at 12 weeks.
Primary	Physical Activity Level Change	It will be assessed by the International Physical Activity Questionnaire- short form (IPAQ). 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).	Change from Baseline Physical Activity Level at 12 weeks.
Primary	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.	Change from Baseline Timed Up And Go Test Results at 12 weeks.
Primary	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. Blood pressure and heart rate values and how many meters they walked will be recorded as a result of the test.	Change from Baseline 6-minute Walking Test Results at 12 weeks.
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	Systolic Blood Pressure	The pressure that builds up in the blood vessels when the heart contracts. It is measured with a sphygmomanometer. It is placed 2.5 to 3 cm above the inside of the elbow. The stethoscope is clamped under the cuff and pressed lightly. The sphygmomanometer air is then inflated to 20 to 30 mmHg above the level at which blood pressure disappears. The control valve should be opened slightly and air should be vented to 2-4 mmHg per second. The first sound heard as the air is evacuated 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).
Primary	Diastolic Blood Pressure	The pressure that builds up in the blood vessels as the heart relaxes. It is measured with a sphygmomanometer. It is placed 2.5 to 3 cm above the inside of the elbow. The stethoscope is clamped under the cuff and pressed lightly. The sphygmomanometer air is then inflated to 20 to 30 mmHg above the level at which blood pressure disappears. The control valve should be opened slightly and air should be vented to 2-4 mmHg per second. The value at which the sound is 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).
Primary	Hearth 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	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. Tanita SC-330 will be used in our study.	Change from Baseline Bioelectrical Impedance Analysis at 12 weeks.
Secondary	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.	Change from Baseline Skinfold Analysis at 12 weeks.
Secondary	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.	Change from Baseline Fingertip-to-floor Distance Measure at 12 weeks.
Secondary	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.	Change from Baseline Trunk Lateral Flexion Measure at 12 weeks.
Secondary	Life Quality	Diabetes will be assessed by the Quality of Life Scale (DQOL). The questionnaire with 4 sub-sections consists of 45 questions. Satisfaction section, Very satisfied- Moderately pleased- None- Slightly satisfied- Not satisfied at all options; psychological effect of treatment, Never- Very Rare- Sometimes -Frequently -Always from the options; The anxiety / anxiety about the later state of the disease consists of Never - Rarely - Sometimes Often - Always and the social and occupational anxiety section, Never - Rarely - Sometimes - Often - Always. With these sections, the questionnaire evaluates the quality of life from different angles. High score is associated with higher quality of life.	In the beginning of the intervention and at the end of the exercise program (12 weeks).
Secondary	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.	In the beginning of the intervention and at the end of the exercise program (12 weeks).
Secondary	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.	In the beginning of the intervention and at the end of the exercise program (12 weeks).
Secondary	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 and at the end of the exercise program (12 weeks).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	Body Mass Index (BMI)	BMI will be calculated by dividing body weight (kg) by height square (m ²).	In the beginning of the intervention and at the end of the exercise program (12 weeks).