Effects of Physical Activity in Patients With Diabetes

NCT04643873 | Completed

• 1 other identifier: 13022260-300-95767
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; PreDiabetes

Keywords

exercise; diabetus mellitus; type 2; counseling; prediabetic state

Outcome Measures

Primary Outcomes (9)

• 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

  up to 12 weeks

• 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

  up to 12 weeks

• HDL

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

  up to 12 weeks

• 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

  up to 12 weeks

• 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

  up to 12 weeks

• 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)

  up to 12 weeks

• percentage of body fat

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

  up to 12 weeks

• 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

  up to 12 weeks

• Step number

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

  up to 12 weeks

Secondary Outcomes (9)

• Short version of IPAQ (International Physical Activity Questionnaire)

  up to 12 weeks

• SF36 (Short Form 36)

  up to 12 weeks

• 6 minutes walk test

  up to 12 weeks

• BMI (body mass index)

  up to 12 weeks

• amount of visceral fat

  up to 12 weeks

Study Arms (3)

Experimental group 1

EXPERIMENTAL

physical activity counseiling +pilates exercise group

Other: physical activity counseiling +pilates exercise group

Experimental group 2

EXPERIMENTAL

only physical activity counseiling group

Behavioral: physical activity counseiling group

Control Group

NO INTERVENTION

only followed by family physician

Interventions

physical activity counseiling +pilates exercise group OTHER

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

Also known as: exercise

Experimental group 1

physical activity counseiling group BEHAVIORAL

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

Experimental group 2

Eligibility Criteria

• Age: Up to 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Merve Suay

Hatay, 31350, Turkey (Türkiye)

Location

Related Links

• 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

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• ela tarakcı, prof dr

  Istanbul University- Cerrahpasa Physiotherpy and Rehabilitation Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: November 25, 2020
• Study Start: October 30, 2020
• Primary Completion: January 12, 2023
• Study Completion: June 1, 2023
• Last Updated: October 26, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)