Comparison Effects Of Different Exercise Approaches On Type 2 DM Women

NCT05479435 | Completed Results DMC

• 1 other identifier: 10840098-604.01.01-E.14291
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (13)

• Glycosylated Hemoglobin Change

  Hemoglobin A1c is a blood test used to measure the effectiveness of treatment in diabetes, and sometimes to diagnose diabetes. The generally accepted reference range for Hemoglobin A1c (HbA1c) is between 4% and 6%.

  Change from Baseline Glycosylated Hemoglobin at 12 weeks.

• Physical Activity Level Change

  The questionnaire provides information about the time spent by the individual in light, moderate, and vigorous activities and sitting in the last 7 days. The MET-min / week score is obtained by multiplying the MET value (metabolic equivalent) by days and minutes for each activity level. Physical activity levels are classified as: Physically inactive (\<600 MET-min / week), Low physical activity (600-3000 MET-min / week), and Adequate physical activity (\> 3000 MET-min / week). A higher score is associated with a higher physical activity level.

  In the beginning of the intervention and at the end of the exercise program (12 weeks)

• Functional Capacity Change With Timed Up And Go Test

  The participant will sit on a chair without armrests, stand up with the command to start, walk 3 meters towards the designated point, turn around and walk to the starting point again and sit. The test is repeated 3 times and the average is taken. The time will be recorded in seconds. As time increases, the risk of falling increases.

  In the beginning of the intervention and at the end of the exercise program (12 weeks)

• Functional Capacity Change With 6-minute Walking Test

  It will be performed in a 30 meter long corridor or in an open area. The participant will be asked to walk without running at the highest speed for 6 minutes. Before and during the march, the participant will be verbally encouraged and motivated. How many meters they walked will be recorded as a result of the test. Six-minute walk test results can be interpreted as follows: Normal: more than 500 meters Light restriction: 400 to 500 meters Moderate restriction: 300 to 400 meters Severe restriction: between 200 - 300 meters Serious restriction: less than 200 meters.

  Change from Baseline 6-minute Walking Test Results at 12 weeks.

• Fasting Plasma Glucose

  Measured level of glucose in the blood after 8 to 12 hours of fasting. The unit of measurement is mg/dL, the reference range is 70-110 mg/dL.

  In the beginning of the intervention and at the end of the exercise program (12 weeks).

• High Density Lipoprotein

  It takes part in the transport of cholesterol from tissues and vessels to the liver and in the synthesis of vitamin D. The unit of measurement is mg/dL, the reference range is 30-96 mg/dL.

  In the beginning of the intervention and at the end of the exercise program (12 weeks).

• Low Density Lipoprotein

  It provides the transport of cholesterol synthesized in the liver to the tissues and blood vessels. The unit of measurement is mg/dL, the reference range is 0- 130 mg/dL.

  In the beginning of the intervention and at the end of the exercise program (12 weeks).

• Total Cholesterol

  Total cholesterol is a value that shows the total amount of cholesterol in the blood. In addition to LDL and HDL, triglyceride levels are also used to calculate total cholesterol. The unit of measurement is mg/dL, the reference range is 70-200 mg/dL.

  In the beginning of the intervention and at the end of the exercise program (12 weeks).

• Triglyceride

  It is a storage nutrient molecule formed by the combination of fatty acids and glycerol molecules, which form the structure of fats in foods. The unit of measurement is mg/dL, the reference range is 0-250 mg/dL.

  In the beginning of the intervention and at the end of the exercise program (12 weeks).

• C-reactive Protein

  It is a protein produced in the liver. It is a protein that is produced by cells and secreted into the blood when the body reacts to conditions such as infection, tumor, trauma, and undertakes various biochemical tasks. The unit of measurement is mg/dL, the reference range is 0-0.5 mg/dL.

  In the beginning of the intervention and at the end of the exercise program (12 weeks).

• Systolic Blood Pressure

  Blood pressure is the pressure that builds up in the blood vessels when the heart contracts. It is measured with a sphygmomanometer. The cuff is placed 2.5 to 3 cm above the inside of the elbow. The stethoscope is placed under the cuff and pressed lightly. The sphygmomanometer cuff is then inflated to 20 to 30 mmHg above the level at which the pulse disappears. The control valve should be opened slightly, and air should be vented at a rate of 2-4 mmHg per second. The first sound heard as the air is released determines the systolic blood pressure. The reference range averages 120 - 130 mmHg.

  In the beginning of the intervention and at the end of the exercise program (12 weeks).

• Diastolic Blood Pressure

  The pressure that builds up in the blood vessels as the heart relaxes is known as diastolic blood pressure. It is measured using a sphygmomanometer, which is placed 2.5 to 3 cm above the inside of the elbow. The stethoscope is placed under the cuff and lightly pressed. The sphygmomanometer cuff is then inflated to 20 to 30 mmHg above the point where the pulse disappears. The control valve should be opened slightly, and air should be released at a rate of 2-4 mmHg per second. The point at which the sound becomes inaudible is considered the diastolic blood pressure. The reference range averages 70 - 90 mmHg.

  In the beginning of the intervention and at the end of the exercise program (12 weeks).

• Heart Rate

  It is the value that shows how many times the heart beats in a minute. Measurement from the wrist: measured from the radial artery with 3 fingers with the palm facing up. The reference range is between 60 and 100 beats per minute (bpm).

  In the beginning of the intervention and at the end of the exercise program (12 weeks).

Secondary Outcomes (13)

• Body Fat Ratio Change With Bioelectrical Impedance Analysis (BIA)

  Change from Baseline Bioelectrical Impedance Analysis at 12 weeks.

• Body Fat Ratio Change With Skinfold Analysis

  Change from Baseline Skinfold Analysis at 12 weeks.

• Flexibility Change With Fingertip-to-floor Distance Measure

  Change from Baseline Fingertip-to-floor Distance Measure at 12 weeks.

• Flexibility Change With Trunk Lateral Flexion Measure

  Change from Baseline Trunk Lateral Flexion Measure at 12 weeks.

• Life Quality

  In the beginning of the intervention and at the end of the exercise program (12 weeks).

Study Arms (3)

Blue Prescription Group

EXPERIMENTAL

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.

Behavioral: Blue Prescription Exercise Program

Video Based Home Exercise Group

ACTIVE COMPARATOR

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.

Behavioral: Video Based Home Exercise Program

Supervised Exercise Group

ACTIVE COMPARATOR

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.

Behavioral: Supervised Group Exercise Program

Interventions

Blue Prescription Exercise Program 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.

Blue Prescription Group

Video Based Home Exercise Program 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.

Video Based Home Exercise Group

Supervised Group Exercise Program 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.

Supervised Exercise Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Type 1 DM
• Using insulin
• Orthopedic and neurological diseases that prevent exercise
• Having cardiovascular, pulmonary and systemic diseases in which exercise is contraindicated.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Arzu Abalay
• Organization: Istanbul Medipol University

arzuabalay@hotmail.com

+905075891917

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: We will mask only person who will do statistical analysis.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phd student

Model Details: Randomized control trial with statistic analyst blind

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: July 29, 2022
• Study Start: September 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: September 30, 2023
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)