Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
90 participants
INTERVENTIONAL
2020-10-30
2023-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Clinical Pilates Exercises on Glycemic Control, Blood Lipids and Physical Fitness Parameters in Prediabetes
NCT06452940
The Effects of Tai Chi and Pilates for Individuals With Prediabetes
NCT06343025
Which Exercises Should Diabetic Patients do?
NCT03475069
Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus
NCT04732611
Metabolic, Physical Responses To Exercise In Patients With Type 2 Diabetes Mellitus
NCT03682445
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
During exercise, oxygen and glucose input to muscle cells increases and regular physical activity provides metabolic control. Many studies have shown that physical activity has a protective effect on impaired glucose tolerance and prevents the risk of cardiovascular diseases and premature death in patients with type 2 diabetes. However, 60-70% of individuals with type 2 diabetes can not reach their daily physical activity goal and most of them can not maintain their regular exercise program. In order to prevent patients from giving up exercise early, it is important to provide personal counseling at certain periods, to encourage, support and advice during exercises, and to explain the exercises in a way that patients can understand.
In our study, patients with type 2 diabetes will be randomly divided into 3 groups as physical activity counseling and pilates exercise group, only physical activity counseling group, and control followed only with family physician recommendations and follow-up. It is planned to do the pilates exercises for 50 minutes a day, 2 days a week during 12 weeks with physiotherapist. Pilates group patient will make pilates exercise once a week alone. Individual exercise sessions will start with 5-10 minutes of warm-up exercises and end with cool-down exercises in the same time. Overall in the program; stretching exercises in different positions (standing and lying), exercises to increase the flexibility of the trunk muscles, upper extremity movements with and without an exercise ball, strengthening exercises with theraband will be applied. Types of movements to strengthen all abdominal muscles, muscles around the hips, back muscles, muscles in the shoulder girdle (shoulder bridge, corkscrew, roll-up, roll down, clam, side kick, staggered legs, scissors, swimming, swan dive, breast stroke preparation, Abdominal preparation, oblique preparation) will be used alternately in different sessions, from easy to difficult. Pilates exercises will be performed with light and relaxing music.
Within the scope of physical activity, moderate and / or high intensity aerobic exercise recommended by cIntegrating physical activity in primary care practice. The American Journal of Medicine (ACSM) will be recommended 150 minutes in a week. Care will be taken not to take a break for more than 2 days between two exercise days. In addition, strengthening exercises that will maintain or increase muscle strength including large muscle groups at least 3 days a week will be determined in accordance with the patient's current possibilities. Recommendations will be given for possible complications such as hypoglycemia during and after exercise.
During physical activity counseling, considering the current physical and metabolic status of the person, the person-based 5A model of ACSM will be adapted to individuals with diabetes and physical activity consultancy will be provided. The 5A model consists of assess, advise, agree, assist, and arrange subsections.
1. Assess: The person's level of knowledge about physical activity and diabetes, his perspective on exercise, his exercise history, readiness for change, fatigue, personal history and family history, and drug use will be evaluated. By asking open-ended questions, his attitude towards exercise will be determined.
2. Advise: The benefits of physical activity and the risks of physical inactivity will be explained, morbidities that may develop due to diabetes, the relationship of diabetes with physical activity, and exercise types will be mentioned. Short-term and long-term effects of exercise will be explained.
3. Agree: Cooperation will be made with the client in line with the person's wishes, interests and physical activity goals. Environmental resources for physical activity will be evaluated and appropriate guidance will be made. OMRON HJ 109 brand pedometer will be used for determining, monitoring and improving the level of physical activity.
4. Assist: Misunderstanding situations will be explained by helping the person identify and solve their problems with physical activity. Potential resources park, gym, etc., solutions will be produced together for the obstacles on the way to physical activity.
5. Arrange: A follow-up meeting will be held with the client one day a week, and the target will be determined for the next week. At the end of the interviews, the situation is summarized and it is aimed to increase clarity. During the interviews, motivational interview technique will be applied by the consultant, and a person-centered approach will be provided by establishing empathy.
Before and after the 12-week intervention program of all patients, metabolic control variables (body mass index, fasting blood glucose, HbA1c value, HDL, LDL, total cholesterol, triglyceride values) will be evaluated. Physical activity levels with IPAQ, exercise capacity with 6-minute walking test (6MWT), functional balance with Berg balance test and quality of life with SF-36 will be evaluated. Body fat percentage, visceral fat amount, body mass index and muscle mass amounts in the trunk and extremities will be calculated with the Jawon X-Contact 350 device. Exercise intensity during exercise will be determined by speaking test.
Metabolic control variables will be analyzed in the Healthy Life Park Blood Collection Unit affiliated to Iskenderun District Health Directorate after the permits are taken. Evaluation methods, exercise and consultancy applications will be carried out in Iskenderun Healthy Life Center. Only the participants in the family doctor follow-up will continue their routine doctor checks and recommendations.
An "Assessment Form" will be created to record the demographic and disease information of all cases included in the study. Diabetes year, prediabetes diagnosis time, history, family history, treatments taken, medications used, posture analysis with New York Posture Analysis, range of motion, muscle strength and shortness assessment and foot examination will be recorded in the evaluation form. Semmes Weinstein monofilament will be used for foot examination.
All analyzes will be performed using SPSS (Statistical Package for Social Sciences) for Windows 22. The compliance of the data to normal distribution will be evaluated by drawing the Kolmogorov-Smirnov test and histogram. Parametric tests will be used for data suitable for normal distribution. Data that are not suitable for normal distribution will be analyzed with non-parametric tests. Variables will be defined by their mean and standard deviation values. Analyzes and correlations between groups will be examined separately with appropriate tests. A value of p\<0.05 will be considered statistically significant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group 1
physical activity counseiling +pilates exercise group
physical activity counseiling +pilates exercise group
It is planned to do the pilates exercises for 50 minutes a day, 2 days a week during 12 weeks with physiotherapist. Pilates group patient will make pilates exercise once a week alone During physical activity counseling, considering the current physical and metabolic status of the person, the person-based 5A model of ACSM will be adapted to individuals with diabetes and physical activity consultancy will be provided
Experimental group 2
only physical activity counseiling group
physical activity counseiling group
During physical activity counseling, considering the current physical and metabolic status of the person, the person-based 5A model of ACSM will be adapted to individuals with diabetes and physical activity consultancy will be provided. Patients make aerobic and strengthening exercises by theirself based on phyiotherapist's suggestions
Control Group
only followed by family physician
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
physical activity counseiling +pilates exercise group
It is planned to do the pilates exercises for 50 minutes a day, 2 days a week during 12 weeks with physiotherapist. Pilates group patient will make pilates exercise once a week alone During physical activity counseling, considering the current physical and metabolic status of the person, the person-based 5A model of ACSM will be adapted to individuals with diabetes and physical activity consultancy will be provided
physical activity counseiling group
During physical activity counseling, considering the current physical and metabolic status of the person, the person-based 5A model of ACSM will be adapted to individuals with diabetes and physical activity consultancy will be provided. Patients make aerobic and strengthening exercises by theirself based on phyiotherapist's suggestions
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Not using insulin
* Being under the age of 70
* Be woman
* Individuals regulated by glucose control, medication and / or diet
* Volunteering to exercise at least 3 days a week in the intervention group within the scope of the research
* Being able to communicate in Turkish written and verbal
Exclusion Criteria
* Body mass index over 35 kg / m²
* Being a communication problem, not being able to cooperate
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul University - Cerrahpasa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
merve şuay üçgül
principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ela tarakcı, prof dr
Role: STUDY_CHAIR
Istanbul University- Cerrahpasa Physiotherpy and Rehabilitation Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Merve Suay
Hatay, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Integrating Physical Activity in Primary Care Practice
WHO Global report on diabetes: A summary. International Journal of Noncommunicable Diseases. 2016;1(1):3.
Combined exercise for people with type 2 diabetes mellitus: a systematic review
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13022260-300-95767
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.