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Effects of Physical Activity in Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04643873
Recruitment Status : Active, not recruiting
First Posted : November 25, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
merve şuay üçgül, Istanbul University-Cerrahpasa

Brief 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, and to compare the relationship between those under medical supervision by family doctor.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus PreDiabetes Other: physical activity counseiling +pilates exercise group Behavioral: physical activity counseiling group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Physical Activity Counseling and Pilates Exercises on Metabolic Control Variables in Patients With Prediabetes and Type 2 Diabetes
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : September 6, 2021
Estimated Study Completion Date : October 6, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group 1
physical activity counseiling +pilates exercise group
Other: 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
Other Name: exercise

Experimental: Experimental group 2
only physical activity counseiling group
Behavioral: 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

No Intervention: Control Group
only followed by family physician



Primary Outcome Measures :
  1. fasting blood glucose [ Time Frame: through study completion, an average of 1 day ]
    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

  2. HbA1c [ Time Frame: through study completion, an average of 1 day ]
    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

  3. HDL [ Time Frame: through study completion, an average of 1 day ]
    HDL (high-density lipoprotein cholesterol) cholesterol: High density lipoprotein cholesterol.60 mg/dL (1.6 mmol/L) or above is desirable

  4. LDL [ Time Frame: through study completion, an average of 1 day ]
    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

  5. total cholesterol [ Time Frame: through study completion, an average of 1 day ]
    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

  6. triglyceride values [ Time Frame: through study completion, an average of 1 day ]
    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)

  7. BMI (body mass index) [ Time Frame: through study completion, an average of 1 day ]
    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

  8. percentage of body fat [ Time Frame: through study completion, an average of 1 day ]
    Body fat percentage will be calculated with the Jawon X-Contact 350 device

  9. amount of visceral fat [ Time Frame: through study completion, an average of 1 day ]

    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.


  10. Muscle mass amounts in the trunk and extremities [ Time Frame: through study completion, an average of 1 day ]
    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


Secondary Outcome Measures :
  1. Long version of IPAQ (International Physical Activity Questionnaire) [ Time Frame: through study completion, an average of 1 day ]

    Long 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


  2. SF36 (Short Form 36) [ Time Frame: through study completion, an average of 1 day ]
    SF36 will be used to measure quality of life Scoring between 0-100 High score means higher quality of life

  3. 6 minutes walk test [ Time Frame: through study completion, an average of 1 day ]
    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



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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643873


Locations
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Turkey
Merve Suay
Hatay, Turkey, 31350
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Study Chair: ela tarakcı, prof dr Istanbul University- Cerrahpasa Physiotherpy and Rehabilitation Department
Additional Information:
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Responsible Party: merve şuay üçgül, principal investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04643873    
Other Study ID Numbers: 13022260-300-95767
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by merve şuay üçgül, Istanbul University-Cerrahpasa:
exercise
diabetus mellitus
type 2
counseling
prediabetic state
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia