NCT05479435

Comparison Effects Of Different Exercise Approaches On Type 2 DM Women

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Istanbul Medipol University Hospital · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Blue Prescription Exercise Program	After the evaluation, participants will receive feedback and physical activity training, along with an explanation of the benefits of exercise, provided in the form of a brochure. They will then be enrolled in the Blue Prescription program, which includes weekly follow-ups for 12 weeks and a re-evaluation at the end of the 12th week. Motivation and support will be offered in accordance with the Blue Prescription philosophy, addressing home exercise programs, physical activity selection, and overcoming obstacles. Participants will be encouraged to determine the most suitable program for themselves and maintain an activity diary. Throughout the study, participants will have the opportunity to communicate with the physiotherapist via various methods such as phone, SMS, or email.
BEHAVIORAL	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.
BEHAVIORAL	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. Participants will engage in exercises with a physiotherapist three days a week for 12 weeks, and the effectiveness of the program will be re-evaluated at the end of the 12th week.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-03-01
• Completion: 2023-09-30
• First posted: 2022-07-29
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

1 site across 1 country: Turkey (Türkiye)