Comparison Effects Of Blue Prescription Program, Home Exercise Program And Supervised Exercise Approaches On Type 2 Diabetic Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Istanbul Medipol University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Glycosylated Hemoglobin Change
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief 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. 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.
Investigators
aabalay
phd student
Istanbul Medipol University Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Using insulin
- •Orthopedic and neurological diseases that prevent exercise
- •Having cardiovascular, pulmonary and systemic diseases in which exercise is contraindicated.
Outcomes
Primary Outcomes
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%.
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.
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.
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).
Secondary Outcomes
- Body Fat Ratio Change With Bioelectrical Impedance Analysis (BIA)(Change from Baseline Bioelectrical Impedance Analysis at 12 weeks.)
- Body Fat Ratio Change With Skinfold Analysis(Change from Baseline Skinfold Analysis at 12 weeks.)
- Flexibility Change With Fingertip-to-floor Distance Measure(Change from Baseline Fingertip-to-floor Distance Measure at 12 weeks.)
- Flexibility Change With Trunk Lateral Flexion Measure(Change from Baseline Trunk Lateral Flexion Measure at 12 weeks.)
- Life Quality(In the beginning of the intervention and at the end of the exercise program (12 weeks).)
- Depression(In the beginning of the intervention and at the end of the exercise program (12 weeks).)
- Contentment(In the beginning of the intervention and at the end of the exercise program (12 weeks).)
- Height(In the beginning of the intervention)
- Weight(In the beginning of the intervention and at the end of the exercise program (12 weeks).)
- Waist Circumference(In the beginning of the intervention and at the end of the exercise program (12 weeks).)
- Neck Circumference(In the beginning of the intervention and at the end of the exercise program (12 weeks).)
- Hip Circumference(In the beginning of the intervention and at the end of the exercise program (12 weeks).)
- Body Mass Index (BMI)(In the beginning of the intervention and at the end of the exercise program (12 weeks).)