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N/A N=60 Randomized Health Services Research

Comparison Effects Of Different Exercise Approaches On Type 2 DM Women

Type 2 Diabetes

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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