N/A
N=60
Comparison Effects Of Different Exercise Approaches On Type 2 DM Women
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05479435 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Glycosylated Hemoglobin Change — 6.82; 7.17; 6.80; 6.33 percentage of glycosylated hemoglobin — p=0.830
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blue Prescription Exercise Program (Behavioral); Video Based Home Exercise Program (Behavioral); Supervised Group Exercise Program (Behavioral)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Istanbul Medipol University Hospital
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Hemoglobin Change |
6.82; 7.17; 6.80; 6.33; 6.69; 6.32 | 0.830 |
| PRIMARY Physical Activity Level Change |
846.45; 797.20; 909.64; 1960.89; 1654.05; 2370.11 | 0.654 |
| PRIMARY Functional Capacity Change With Timed Up And Go Test |
10.64; 10.31; 10.62; 9.21; 8.99; 9.26 | 0.803 |
| PRIMARY Functional Capacity Change With 6-minute Walking Test |
402.57; 405.95; 416.97; 462.82; 457.85; 483.44 | 0.398 |
| PRIMARY Fasting Plasma Glucose |
138.21; 157.05; 128.33; 115.53; 145.50; 118.28 | 0.132 |
| PRIMARY High Density Lipoprotein |
52.74; 54.30; 54.83; 59.05; 59.20; 62.53 | 0.991 |
| PRIMARY Low Density Lipoprotein |
136.58; 123.45; 156.00; 125.37; 116.90; 130.33 | 0.278 |
| PRIMARY Total Cholesterol |
219.21; 208.40; 221.28; 203.00; 189.90; 200.61 | 0.479 |
| PRIMARY Triglyceride |
173.16; 172.15; 203.12; 156.00; 152.85; 184.22 | 0.849 |
| PRIMARY C-reactive Protein |
2.31; 1.55; 3.51; 1.83; 1.51; 2.46 | 0.504 |
| PRIMARY Systolic Blood Pressure |
128.63; 129.05; 134.78; 123.63; 126.30; 129.17 | 0.017 sig |
| PRIMARY Diastolic Blood Pressure |
77.05; 80.10; 83.50; 75.47; 78.85; 81.39 | 0.025 sig |
| PRIMARY Heart Rate |
72.63; 73.70; 76.56; 71.16; 72.30; 74.11 | 0.016 sig |
| SECONDARY Body Fat Ratio Change With Bioelectrical Impedance Analysis (BIA) |
43.63; 40.27; 43.54; 41.79; 38.30; 41.06 | 0.041 sig |
| SECONDARY Body Fat Ratio Change With Skinfold Analysis |
42.76; 41.59; 43.36; 41.85; 40.78; 42.55 | 0.352 |
| SECONDARY Flexibility Change With Fingertip-to-floor Distance Measure |
9.05; 10.90; 9.67; 4.16; 7.70; 5.67 | 0.390 |
| SECONDARY Flexibility Change With Trunk Lateral Flexion Measure |
12.95; 13.68; 12.61; 17.47; 17.15; 18.89 | 0.928 |
| SECONDARY Life Quality |
3.57; 3.61; 3.61; 4.31; 4.29; 4.60 | 0.558 |
| SECONDARY Depression |
12.95; 13.15; 16.17; 9.37; 9.65; 9.78 | 0.133 |
| SECONDARY Contentment |
21.37; 22.30; 19.28; 29.63; 29.75; 32.17 | 0.367 |
| SECONDARY Height |
1.57; 1.58; 1.59 | 0.631 |
| SECONDARY Weight |
88.55; 79.87; 87.93; 84.69; 77.96; 81.40 | 0.056 |
| SECONDARY Neck Circumference |
38.13; 38.05; 38.53; 37.05; 36.95; 36.83 | 0.979 |
| SECONDARY Waist Circumference |
104.42; 103.10; 109.56; 100.16; 98.60; 102.78 | 0.377 |
| SECONDARY Hip Circumference |
120.58; 113.60; 116.72; 117.84; 111.90; 112.17 | 0.979 |
| SECONDARY Body Mass Index (BMI) |
35.93; 32.04; 34.76; 34.36; 31.24; 32.32 | 0.055 |
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
- 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
- Type 1 DM
- Using insulin
- Orthopedic and neurological diseases that prevent exercise
- Having cardiovascular, pulmonary and systemic diseases in which exercise is contraindicated.
Data sourced from ClinicalTrials.gov (NCT05479435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.