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

Not Applicable
Conditions
COPD
Interventions
Procedure: aerobic exercise with blood flow restriction
Registration Number
NCT04526184
Lead Sponsor
Medipol University
Brief Summary

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.

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.

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
Male
Target Recruitment
46
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
patient groupaerobic exercise with blood flow restriction25 individuals will be selected randomly from 103 patients with COPD from hospital records.
healthy groupaerobic exercise with blood flow restriction25 healthy individuals between the ages of 40-70 will be contacted by phone and included in the initiative.
Primary Outcome Measures
NameTimeMethod
C reactive protein, neutrophil30 minutes

inflammatory marker

modified borg scaleup to 18 weeks.

dyspnoea measurement, Minimum 1, maximum 7 points are obtained. 5 indicates the best respiratory condition, 10 the worst respiratory condition.

oxidative stress markersup to 18 weeks

uric acid, lactate dehydrogenase

creatine kinase30 minutes

rhabdomyolysis marker

heart rate30 minutes

determination of aerobic exercise dose

oxygen saturation30 minutes

blood oxygen saturation

systolic and diastolic pressureup to 18 weeks

to mean arterial pressure calculation

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Karabük Üniversitesi Araştırma Hastanesi Göğüs Hastalıkları Kliniği

🇹🇷

Karabük, Turkey

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