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

NCT04330911 | Completed

• 1 other identifier: 09.2019.172
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Type-2 Diabetes

Outcome Measures

Primary Outcomes (15)

• Incremental Shuttle Walk Test-ISWT

  Aerobic Capacity

  Baseline Assessment

• Incremental Shuttle Walk Test-ISWT

  Aerobic Capacity

  End of the exercise period assessment (end of the 6. weeks)

• Incremental Shuttle Walk Test-ISWT

  Aerobic Capacity

  End of the follow-up period assessment (end of the 12. weeks)

• Digital Spirometer

  FVC parameters were evaluated automatically.

  Baseline Assessment

• Digital Spirometer

  FVC parameters were evaluated automatically.

  End of the follow-up period assessment (end of the 6. weeks)

• Digital Spirometer

  FVC parameters were evaluated automatically.

  End of the follow-up period assessment (end of the 12. weeks)

• Digital Spirometer

  FEV1 were evaluated automatically.

  Baseline Assessment

• Digital Spirometer

  FEV1 were evaluated automatically.

  End of the follow-up period assessment (end of the 6. weeks)

• Digital Spirometer

  FEV1 were evaluated automatically.

  End of the follow-up period assessment (end of the 12. weeks)

• Digital Spirometer

  FEV1/FVC were evaluated automatically.

  Baseline Assessment

• Digital Spirometer

  FEV1/FVC were evaluated automatically.

  End of the follow-up period assessment (end of the 6. weeks)

• Digital Spirometer

  FEV1/FVC were evaluated automatically.

  End of the follow-up period assessment (end of the 12. weeks)

• Digital Spirometer

  PEF parameters were evaluated automatically.

  Baseline Assessment

• Digital Spirometer

  PEF parameters were evaluated automatically.

  End of the follow-up period assessment (end of the 6. weeks)

• Digital Spirometer

  PEF parameters were evaluated automatically.

  End of the follow-up period assessment (end of the 12. weeks)

Study Arms (2)

The HIIT Group (High Intensity Interval Training Group)

EXPERIMENTAL

Procedure: Aerobic Exercise

The MICT Group (Moderate Intensity Continous Training Group)

EXPERIMENTAL

Procedure: Aerobic Exercise

Interventions

Aerobic Exercise PROCEDURE

Exercise loading is determined by increasing the heart rate. This loading calculated by Karvonen formulas (maximum %80 of Heart Rate)

The HIIT Group (High Intensity Interval Training Group); The MICT Group (Moderate Intensity Continous Training Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emresenocak: lead

Study Sites (1)

Marmara University

Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: February 1, 2019
• Primary Completion: March 15, 2019
• Study Completion: May 1, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)