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

Medipol University

Status: Invitation-only

Conditions: COPD

Treatments: Procedure: aerobic exercise with blood flow restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT04526184

IMU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

healthy group

Active Comparator group

Description:

25 healthy individuals between the ages of 40-70 will be contacted by phone and included in the initiative.

Treatment:

Procedure: aerobic exercise with blood flow restriction

patient group

Active Comparator group

Description:

25 individuals will be selected randomly from 103 patients with COPD from hospital records.

Treatment:

Procedure: aerobic exercise with blood flow restriction