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Diabetes MellitusNCT04643873

Effects of Physical Activity in Patients With Diabetes

A study testing physical activity counseiling +pilates exercise group and physical activity counseiling group in people with Diabetes Mellitus and PreDiabetes, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of our study is to evaluate the effects of physical activity counseling and pilates exercises on metabolic control variables in patients with prediabetes and type 2 diabetes; Its secondary aim is to examine the effects of both practices on physical activity level, exercise capacity and quality of life… Read more about this study

Who is it for?
Ages Up to 70 years, women only
Conditions the study is for
Diabetes Mellitus, PreDiabetes
What is being tested?
physical activity counseiling +pilates exercise group and physical activity counseiling group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Oct 2020to 1 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 70 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Having been diagnosed with prediabetes or Type II diabetes at most 10 years ago
  • 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

Who cannot join

  • Having uncontrolled hypertension (160/90 mmHg), cardiovascular problem, renal disease, neuropathy, systemic disease that will create contraindications for exercise
  • Body mass index over 35 kg / m²
  • Being a communication problem, not being able to cooperate

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Merve Suay

    Hatay, 31350

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Physical Activity Counseling and Pilates Exercises on Metabolic Control Variables in Patients With Prediabetes and Type 2 Diabetes:Randomised Controlled Study

The primary aim of our study is to evaluate the effects of physical activity counseling and pilates exercises on metabolic control variables in patients with prediabetes and type 2 diabetes; Its secondary aim is to examine the effects of both practices on physical activity level, exercise capacity and quality of life, and to compare the relationship between those under medical supervision by family doctor.

Read the detailed description

According to the World Health Organization (WHO), diabetes is defined as a disease that occurs when the insulin hormone which is responsible for regulating blood glucose and secreted by the pancreas. It cannot be produced individually or used effectively by the body. It is a chronic disease with high morbidity and mortality and adversely affected by diabetes complications. Purpose in diabetes treatment; control of the individual's blood glucose level, prevention or control of complications. From the moment of diagnosis, healthy lifestyle changes are recommended for metabolic control in individuals with diabetes. Diabetes is classified as type 1, type 2, other specific causes and gestational diabetes according WHO. 90-95% of diabetes cases diagnosed all over the world are type 2 diabetes, 5-10% is type 1 diabetes and 2-3% is other diabetes types.

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.

Being tested
physical activity counseiling +pilates exercise group, physical activity counseiling group
Keywords
exercise, diabetus mellitus, type 2, counseling, prediabetic state
Medical subject headings
Diabetes Mellitus, Prediabetic State, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physical activity counseiling +pilates exercise groupOther

    Also called exercise

    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 groupBehavioural

    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

Study groups in NCT04643873
Study groupRoleWhat they receive
Experimental group 1Experimentalphysical activity counseiling +pilates exercise group
Receives: Other: physical activity counseiling +pilates exercise group
Experimental group 2Experimentalonly physical activity counseiling group
Receives: Behavioral: physical activity counseiling group
Control GroupNo interventiononly followed by family physician

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fasting blood glucose

    A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is normal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes. If it's 126 mg/dL (7 mmol/L) or higher on two separate tests, you have diabetes percentage of body fat, amount of visceral fat, body mass index: amount of muscle mass in the trunk and extremities

    Measured: up to 12 weeks

  2. HbA1c

    A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin. Normal: HbA1c below 5.7% Prediabetes: HbA1c between 5.7% and 6.4% Diabetes: HbA1c of 6.5% or higher

    Measured: up to 12 weeks

  3. HDL

    HDL (high-density lipoprotein cholesterol) cholesterol: High density lipoprotein cholesterol.60 mg/dL (1.6 mmol/L) or above is desirable

    Measured: up to 12 weeks

  4. LDL

    LDL (low-density lipoprotein cholesterol) Adult - < 130 mg/dL is normal value for LDL. Low-density lipoprotein is a type of lipoprotein that consists of cholesterol (LDL cholesterol, LDL-C) and similar substances with a small amount of protein

    Measured: up to 12 weeks

  5. total cholesterol

    Total cholesterol a measure of the total amount of cholesterol in your blood. It includes both low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol. Less than 200 mg/dL is normal

    Measured: up to 12 weeks

  6. triglyceride values

    Triglycerides are a type of fat (lipid) found in blood. Normal is less than 150 milligrams per deciliter (mg/dL), or less than 1.7 millimoles per liter (mmol/L)

    Measured: up to 12 weeks

  7. percentage of body fat

    Body fat percentage will be calculated with the Jawon X-Contact 350 device

    Measured: up to 12 weeks

  8. Muscle mass amounts in the trunk and extremities

    Muscle mass amounts in the trunk and extremities will be calculated with the Jawon X-Contact 350.Muscle mass includes the skeletal muscles, smooth muscles such as cardiac and digestive muscles and the water contained in these muscles

    Measured: up to 12 weeks

  9. Step number

    Average one week steps before and after intervention will be calculated with OMRON HJ 109 pedometer

    Measured: up to 12 weeks

Secondary outcomes (9)
  1. Short version of IPAQ (International Physical Activity Questionnaire)

    Short version of IPAQ will be used to measure physical activity level

    . There are three levels of physical activity proposed to classify populations - 'low', 'moderate', and 'high' Vigorous Intensity = 8.0 METs Moderate Intensity = 4.0 METs

    Measured: up to 12 weeks

  2. SF36 (Short Form 36)

    SF36 will be used to measure quality of life Scoring between 0-100 High score means higher quality of life

    Measured: up to 12 weeks

  3. 6 minutes walk test

    6 minutes walk test will be used to measure exercise capacity The six minute walk distance in healthy adults has been reported to range from 400m to 700m Age and sex-specific reference standards are available and may be helpful for interpreting 6MWT scores for both healthy adults and those with chronic diseases 47 . However, it is difficult to use normative values because of the differing methods used in studies. An improvement of 54m has been shown to be a clinically important difference24 in a study of people with chronic lung disease which is similar to the recommended criteria of meaningful clinical change of 50m based on analyses from a sample of 692 community living older adults and individuals who have survived a stroke 25

    Measured: up to 12 weeks

  4. BMI (body mass index)

    Weight and height will be combined to report BMI in kg/m^2. Underweight = <18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9. Obesity = BMI of 30 or greater

    Measured: up to 12 weeks

  5. amount of visceral fat

    Amount of visceral fat will be calculated with the Jawon X-Contact 350 device. Visceral fat is wrapped around major organs like the liver, pancreas and your kidney. Visceral fat ensures that there is some distance between each organ. Too much visceral fat creates can lead to inflammation and high blood pressure, which increases the risk of serious health problems. This is also know as central obesity.

    Based on all the available information Jawon X Contact 350 device gives you a range between 1 and 59. A rating between 1 and 12 indicates that you have a healthy level of visceral fat. A rating between 13 and 59 indicates that you have an excessive level of visceral fat.

    Measured: up to 12 weeks

  6. Berg Balance Scale

    The Berg Balance Scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait

    Measured: up to 12 weeks

  7. waist circumference

    Waist circumference is measured halfway between the lower ribs and the iliac crest

    Measured: up to 12 weeks

  8. hip circumference

    hip circumference is measured at the largest circumference around the buttocks

    Measured: up to 12 weeks

  9. Waist-Hip Circumference Ratio

    The waist-hip ratio is a simple technique for determining body fat distribution

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2020
  2. Study start30 Oct 2020
  3. Primary completion12 Jan 2023
  4. Study completion1 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04643873
Sponsor's protocol ID
13022260-300-95767
Status last verified
May 2023
First submitted
4 Oct 2020
Last updated
26 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing physical activity counseiling +pilates exercise group and physical activity counseiling group in people with Diabetes Mellitus and PreDiabetes, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fasting blood glucose (time frame: up to 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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