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The Effects of Aerobic Exercises on Exercise Capacity in Type-2 Diabetes Mellitus

Primary Purpose

Type-2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic Exercise
Sponsored by
Emresenocak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type-2 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with type-2 diabetes mellitus,
  • patients who have sedentary lifestyle (<3 bouts of exercise per week and <30 minutes aerobic exercise period),
  • non-smoking patients,
  • not to lose more than 5% of total body weight in the last 6 months,
  • blood pressure<160/100 mmHg

Exclusion Criteria:

  • alcohol addiction in the last 12 months,
  • patients who use insulin hormone,
  • patients who have neuropathy or retinopathy,
  • patients who have an acute cardiac event in the last 6 weeks,
  • patients who have a disease at least 2 weeks in the last 1 month

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

The HIIT Group (High Intensity Interval Training Group)

The MICT Group (Moderate Intensity Continous Training Group)

Arm Description

Outcomes

Primary Outcome Measures

Incremental Shuttle Walk Test-ISWT
Aerobic Capacity
Incremental Shuttle Walk Test-ISWT
Aerobic Capacity
Incremental Shuttle Walk Test-ISWT
Aerobic Capacity
Digital Spirometer
FVC parameters were evaluated automatically.
Digital Spirometer
FVC parameters were evaluated automatically.
Digital Spirometer
FVC parameters were evaluated automatically.
Digital Spirometer
FEV1 were evaluated automatically.
Digital Spirometer
FEV1 were evaluated automatically.
Digital Spirometer
FEV1 were evaluated automatically.
Digital Spirometer
FEV1/FVC were evaluated automatically.
Digital Spirometer
FEV1/FVC were evaluated automatically.
Digital Spirometer
FEV1/FVC were evaluated automatically.
Digital Spirometer
PEF parameters were evaluated automatically.
Digital Spirometer
PEF parameters were evaluated automatically.
Digital Spirometer
PEF parameters were evaluated automatically.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2020
Last Updated
April 7, 2020
Sponsor
Emresenocak
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1. Study Identification

Unique Protocol Identification Number
NCT04330911
Brief Title
The Effects of Aerobic Exercises on Exercise Capacity in Type-2 Diabetes Mellitus
Official Title
The Effect of Supervised Exercise Programs on Exercise Capacity and Pulmonary Capacity in Type-2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emresenocak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Diabetes, beyond glycemic control, is a complex chronic disease that requires continuous medical care with multifactorial risk reduction strategies. It is necessary to reduce the likelihood of complications and additional problems that may develop in the long term. For this reason, guiding the patient to manage the disease process, equipping and supporting the patient with the necessary information is critical to prevent acute problems. Exercise is the primary treatment method for diabetes patients. Exercise; It is the main treatment method used to increase aerobic capacity and improve respiratory capacity due to the positive effect it has on the body's structure and systems.
Detailed Description
Firstly, patients were examined by the specialist doctor. If patients appropriate for this study according to inclusion and exclusion criteria, they were consulted to Cardiologist for stress ECG test and acceptation report to high or moderate-intensity aerobic training. After baseline testing (including aerobic capacity and lung capacity), appropriate patients were randomized to HIIT or MICT groups involving sixteenth sessions of exercise performed over 6 weeks The HIIT exercise protocol involved 28 minutes of treadmill efforts. The patients performed the interval training for 4 minutes with 80%HRmax and active recovery period maintained for 3 minutes with 60% HRmax on the treadmill. This protocol repeated 4 times in a session. The MICT exercise protocol performed with %60 HRmax for 28 minutes similarly HIIT group. A 10-min warm-up and 10-min cool-down period were included for all groups. All groups reassessed after the 6. weeks (end of the exercise program) and 12. weeks (follow-up period). Aerobic capacity assessed with an Incremental Shuttle Walk Test (ISWT). Clinicians need to 10 m field, audiotape recorder, chronometer, and two markers. This test consists of 12 levels, every level maintains1 minute and the walking speed is increased after every1 minute intervals. If the patients wanted to stop because of fell breathless or can't reach the end of the 10 m line' last 0.5 m in the time allowed, the test was stopped.Estimated VO2max was calculated a formula as "Estimated VO2max (ml/dk/kg)= 4.19 + (0.025 x ISWT distance)". The patient's pulmonary functions assessed with a digital spirometer (Pony FX, COSMED Inc., Italy). Spirometer device measures FVC, FEV1, FEV1/FVC and PEF values. During the test, upper extremity was straight and patients sitting straight position on the chair with their vertical feet on the floor. The measurements were performed 3 times and the best score recorded with mean and standard deviation. The measurements were coded into the analysis program and checked by a second researcher. Post-hoc power analysis was done using aerobic capacity data, which is the main output of our study. The power of the study was determined as 94%. Patients who had missing data, patients who did not complete the 6-weeks exercise program and 12. weeks follow-up period were excluded from the analysis. All analyses were performed using the Statistical Package for the Social Sciences (SPSS) version 22. 0 for Windows. Data are expressed as mean ± standard deviation. The one-sample Kolmogorov-Smirnov test was performed to assess the distribution of data. Due to their distribution, numerical variables in different subjects were compared with the t-test or Mann-Whitney U test. Comparison of variables before and after the exercise program were compared by the paired t-test (parametric variable) or Wilcoxon test (non-parametric variable). Probability values were two-tailed, and a p-value of less than 0.05 was considered as significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type-2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
High-Intensity Interval Training Group (HIIT): The HIIT exercise protocol involved 28 minutes of treadmill efforts. The patients performed the interval training for 4 minutes with 80%HRmax and active recovery period maintained for 3 minutes with 60% HRmax on the treadmill with Karvonen formula.This protocol repeated 4 times in a session for 6 weeks. Moderate Intensity Continous Training (MICT): The MICT exercise protocol performed with %60 HRmax for 28 minutes for 6 weeks.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The HIIT Group (High Intensity Interval Training Group)
Arm Type
Experimental
Arm Title
The MICT Group (Moderate Intensity Continous Training Group)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Aerobic Exercise
Intervention Description
Exercise loading is determined by increasing the heart rate. This loading calculated by Karvonen formulas (maximum %80 of Heart Rate)
Primary Outcome Measure Information:
Title
Incremental Shuttle Walk Test-ISWT
Description
Aerobic Capacity
Time Frame
Baseline Assessment
Title
Incremental Shuttle Walk Test-ISWT
Description
Aerobic Capacity
Time Frame
End of the exercise period assessment (end of the 6. weeks)
Title
Incremental Shuttle Walk Test-ISWT
Description
Aerobic Capacity
Time Frame
End of the follow-up period assessment (end of the 12. weeks)
Title
Digital Spirometer
Description
FVC parameters were evaluated automatically.
Time Frame
Baseline Assessment
Title
Digital Spirometer
Description
FVC parameters were evaluated automatically.
Time Frame
End of the follow-up period assessment (end of the 6. weeks)
Title
Digital Spirometer
Description
FVC parameters were evaluated automatically.
Time Frame
End of the follow-up period assessment (end of the 12. weeks)
Title
Digital Spirometer
Description
FEV1 were evaluated automatically.
Time Frame
Baseline Assessment
Title
Digital Spirometer
Description
FEV1 were evaluated automatically.
Time Frame
End of the follow-up period assessment (end of the 6. weeks)
Title
Digital Spirometer
Description
FEV1 were evaluated automatically.
Time Frame
End of the follow-up period assessment (end of the 12. weeks)
Title
Digital Spirometer
Description
FEV1/FVC were evaluated automatically.
Time Frame
Baseline Assessment
Title
Digital Spirometer
Description
FEV1/FVC were evaluated automatically.
Time Frame
End of the follow-up period assessment (end of the 6. weeks)
Title
Digital Spirometer
Description
FEV1/FVC were evaluated automatically.
Time Frame
End of the follow-up period assessment (end of the 12. weeks)
Title
Digital Spirometer
Description
PEF parameters were evaluated automatically.
Time Frame
Baseline Assessment
Title
Digital Spirometer
Description
PEF parameters were evaluated automatically.
Time Frame
End of the follow-up period assessment (end of the 6. weeks)
Title
Digital Spirometer
Description
PEF parameters were evaluated automatically.
Time Frame
End of the follow-up period assessment (end of the 12. weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with type-2 diabetes mellitus, patients who have sedentary lifestyle (<3 bouts of exercise per week and <30 minutes aerobic exercise period), non-smoking patients, not to lose more than 5% of total body weight in the last 6 months, blood pressure<160/100 mmHg Exclusion Criteria: alcohol addiction in the last 12 months, patients who use insulin hormone, patients who have neuropathy or retinopathy, patients who have an acute cardiac event in the last 6 weeks, patients who have a disease at least 2 weeks in the last 1 month
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34083
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Aerobic Exercises on Exercise Capacity in Type-2 Diabetes Mellitus

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