Systemic Effects of A Continuous Blood Flow Restricted Aerobic Exercise Session in COPD Patients: A Randomised Controlled Trial.

March 19, 2024 updated by: Ahmet Gunes, Medipol University

Patients with COPD that a pulmonologist classifies between Stage 1-2 in accordance with the GOLD criteria and age and gender-matched healthy individuals will be included in the study.

In both groups (n = COPD: 17, Healthy: 17), aerobic exercise (AE) in the target heart rate range of 50% intensity, performed by cycling accompanied by blood flow restriction, will be applied.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Target heart rate will be calculated from the formula "(Maximal heart rate-resting heart rate) x% desired intensity ratio + resting heart rate".

The target occlusion amount in the lower extremity will be calculated by calculating 45% of the complete occlusion rates reported by Michael et al. The proximal border of the thigh cuffs will be tied in line with the gluteal lines on both sides.

Exercise tolerance and dyspnea condition; Measurement properties in COPD will be evaluated using a well-defined modified Borg scale (MBS). Individuals will use any bronchodilator that their doctor sees fit before trying.

The target aerobic exercise intensity will be reached in the last minute of the first five-minute warm-up period by maintaining a 4-6 feeling of dyspnea in the MBS, by increasing pedal resistance and speed. In case of extreme shortness of breath, exercise intensity will be reduced to resting heart rate.

In the event of oxygen desaturation (85%) during the intervention, the intervention will be terminated.

Aerobic exercise training protocol; It was planned as 50 rpm speed and warming up at the lowest pedal resistance during the first 4 minutes, reaching the target exercise intensity range in the next 1 minute, aerobic training at the target heart rate range and appropriate MBS value for the next 20 minutes, cooling down in the last 5 minutes. The duration will be reduced in case of excessive shortness of breath, fatigue and muscle pain due to increased exercise volume. The distance, calories, and maximum speed values measured during the study will be recorded.

Before and immediately after the study, all participants had muscle damage (creatine kinase), anti-inflammatory response (CRP, neutrophil), oxidative stress response (uric acid, LDH), oxygen saturation, heart rate, systolic and diastolic pressure will be examined.

Institution of the Study: Karabuk University Research Hospital Chest Diseases Clinic Center / Karabuk. The study would be conducted in the presence of a chest diseases specialist.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Karabük, Turkey, 78600
        • Karabük Üniversitesi Araştırma Hastanesi Göğüs Hastalıkları Kliniği

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • No drug change for at least 30 days for the COPD group
  • Not participating in a structured activity program for at least six months
  • Have the ability to cooperate

Exclusion Criteria:

  • Presence of any pathology that limits physical activity performance
  • Presence of severe or unstable heart disease
  • Presence of peripheral artery disease
  • Being in an exacerbation period of the disease
  • Presence of another active disease (rheumatic, oncological, traumatic etc.)
  • Any neurological or orthopedic disease that prevents exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: healthy group
25 healthy individuals between the ages of 40-70 will be contacted by phone and included in the initiative.
Procedure: aerobic exercise with blood flow restriction
Patients and healthy individuals will be given 30 minutes of aerobic exercise by cycling, by restricting lower extremity blood flow.
Active Comparator: patient group
25 individuals will be selected randomly from 103 patients with COPD from hospital records.
Procedure: aerobic exercise with blood flow restriction
Patients and healthy individuals will be given 30 minutes of aerobic exercise by cycling, by restricting lower extremity blood flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
creatine kinase
Time Frame: 30 minutes
rhabdomyolysis marker
30 minutes
heart rate
Time Frame: 30 minutes
determination of aerobic exercise dose
30 minutes
C reactive protein, neutrophil
Time Frame: 30 minutes
inflammatory marker
30 minutes
oxygen saturation
Time Frame: 30 minutes
blood oxygen saturation
30 minutes
systolic and diastolic pressure
Time Frame: up to 18 weeks
to mean arterial pressure calculation
up to 18 weeks
modified borg scale
Time Frame: up to 18 weeks.
dyspnoea measurement, Minimum 1, maximum 7 points are obtained. 5 indicates the best respiratory condition, 10 the worst respiratory condition.
up to 18 weeks.
oxidative stress markers
Time Frame: up to 18 weeks
uric acid, lactate dehydrogenase
up to 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Estimated)

March 19, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 21, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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