Clinical trial NCT05479435: Comparison Effects Of Different Exercise Approaches On Type 2 DM Women
Official title: Comparison Effects Of Blue Prescription Program, Home Exercise Program And Supervised Exercise Approaches On Type 2 Diabetic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial with statistic analyst blind
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glycosylated Hemoglobin Change
timeFrame: Change from Baseline Glycosylated Hemoglobin at 12 weeks.
measure: Physical Activity Level Change
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks)
measure: Functional Capacity Change With Timed Up And Go Test
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks)
measure: Functional Capacity Change With 6-minute Walking Test
timeFrame: Change from Baseline 6-minute Walking Test Results at 12 weeks.
measure: Fasting Plasma Glucose
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: High Density Lipoprotein
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Low Density Lipoprotein
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Total Cholesterol
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Triglyceride
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: C-reactive Protein
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Systolic Blood Pressure
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Diastolic Blood Pressure
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Heart Rate
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Secondary outcomes:
measure: Body Fat Ratio Change With Bioelectrical Impedance Analysis (BIA)
timeFrame: Change from Baseline Bioelectrical Impedance Analysis at 12 weeks.
measure: Body Fat Ratio Change With Skinfold Analysis
timeFrame: Change from Baseline Skinfold Analysis at 12 weeks.
measure: Flexibility Change With Fingertip-to-floor Distance Measure
timeFrame: Change from Baseline Fingertip-to-floor Distance Measure at 12 weeks.
measure: Flexibility Change With Trunk Lateral Flexion Measure
timeFrame: Change from Baseline Trunk Lateral Flexion Measure at 12 weeks.
measure: Life Quality
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Depression
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Contentment
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Height
timeFrame: In the beginning of the intervention
measure: Weight
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Neck Circumference
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Waist Circumference
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Hip Circumference
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
measure: Body Mass Index (BMI)
timeFrame: In the beginning of the intervention and at the end of the exercise program (12 weeks).
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References: