Comparison Effects Of Different Exercise Approaches On Type 2 DM Women

Medipol Health Group

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Supervised Group Exercise Program; Behavioral: Video Based Home Exercise Program; Behavioral: Blue Prescription Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05479435

10840098-604.01.01-E.14291

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Blue Prescription Group

Experimental group

Description:

Participants will receive an exercise program designed according to their needs, desires, and abilities. They will perform the desired exercise program three days a week and will have an interview for motivation and/or modifying the program one day a week. They will also keep an activity diary.

Treatment:

Behavioral: Blue Prescription Exercise Program

Video Based Home Exercise Group

Active Comparator group

Description:

Participants will receive videos through various channels. They will perform exercises three days a week. The investigator will call them to inquire whether they are following the program or not. Additionally, they will keep an activity diary.

Treatment:

Behavioral: Video Based Home Exercise Program

Supervised Exercise Group

Active Comparator group

Description:

Participants will perform an exercise program 3 days a week under the guidance of a physiotherapist. Each group will consist of a maximum of 10 people.

Treatment:

Behavioral: Supervised Group Exercise Program