Comparison Effects Of Different Exercise Approaches On Type 2 DM Women

NCT ID: NCT05479435

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-09-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Blue Prescription Group

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.

Group Type: EXPERIMENTAL

Blue Prescription Exercise Program

Intervention Type: BEHAVIORAL

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.

Video Based Home Exercise Group

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.

Group Type: ACTIVE_COMPARATOR

Video Based Home Exercise Program

Intervention Type: BEHAVIORAL

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.

Supervised Exercise Group

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.

Group Type: ACTIVE_COMPARATOR

Supervised Group Exercise Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

aabalay

phd student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

10840098-604.01.01-E.14291

Identifier Type: -

Identifier Source: org_study_id