Skip to content

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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04526184
Enrollment
46
Registered
2020-08-25
Start date
2020-08-17
Completion date
2024-04-15
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

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.

Interventions

Patients and healthy individuals will be given 30 minutes of aerobic exercise by cycling, by restricting lower extremity blood flow.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

25 COPD patients were referred to the study from the pulmonology clinic of the hospital where the study was conducted by a medical secretary who was blinded to the intervention. In addition, 21 healthy individuals volunteered to participate in the study from the same hospital where the study was previously announced.

Intervention model description

Two groups will be formed as healthy and patient groups and the same treatment initiative will be applied.

Eligibility

Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
creatine kinase30 minutesrhabdomyolysis marker
C reactive protein, neutrophil30 minutesinflammatory marker
oxygen saturation30 minutesblood oxygen saturation
heart rate30 minutesdetermination of aerobic exercise dose
systolic and diastolic pressureup to 18 weeksto mean arterial pressure calculation
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 weeksuric acid, lactate dehydrogenase

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026