The Effect of Blood Flow Restricted Aerobic Exercise on Chronic Obstructive Pulmonary Patients
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| ClinicalTrials.gov Identifier: NCT04526184 |
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Recruitment Status :
Enrolling by invitation
First Posted : August 25, 2020
Last Update Posted : December 29, 2020
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Patients with COPD that a pulmonologist classifies between Stage 1-4 in accordance with the GOLD criteria and age and gender-matched healthy individuals will be included in the study.
In both groups (n = COPD: 25, Healthy: 25), aerobic exercise (AE) in the target heart rate range of 50% intensity, performed by cycling accompanied by blood flow restriction, will be applied.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COPD | Procedure: aerobic exercise with blood flow restriction | Not Applicable |
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 rhabdomyolysis status (creatine kinase), risk of venous thromboembolism (D-dimer, CRP), anti-inflammatory response (IL-6), oxygen saturation, heart rate, systolic and diastolic pressure, respiratory rate, six-minute walking test parameters 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 (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Two groups will be formed as healthy and patient groups and the same treatment initiative will be applied. |
| Masking: | Single (Investigator) |
| Masking Description: | Groups will be formed randomly from 103 COPD patients and healthy individuals contacted by phone. |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of Blood Flow Restricted Aerobic Exercise on Chronic Obstructive Pulmonary Patients: A Comparative Study With a Healthy Group |
| Actual Study Start Date : | August 17, 2020 |
| Estimated Primary Completion Date : | December 28, 2020 |
| Estimated Study Completion Date : | December 29, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: healthy group
25 healthy individuals between the ages of 40-70 will be contacted by phone and included in the initiative.
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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. |
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Active Comparator: patient group
25 individuals will be selected randomly from 103 patients with COPD from hospital records.
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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. |
- creatine kinase [ Time Frame: 30 minutes ]rhabdomyolysis marker
- D-dimer [ Time Frame: 30 minutes ]venous thromboembolism marker
- C reactive protein [ Time Frame: 30 minutes ]clot formation marker
- oxygen saturation [ Time Frame: 30 minutes ]blood oxygen stauration
- heart rate [ Time Frame: 30 minutes ]determination of aerobic exercise dose
- systolic and diastolic pressure [ Time Frame: up to 18 weeks ]aerobic exercise tolerance measurement
- modified borg scale [ Time Frame: up to 18 weeks. ]dyspnoea measurement, Minimum 0, maximum 10 points are obtained. 0 indicates the best respiratory condition, 10 the worst respiratory condition.
- 6 minutes walk test [ Time Frame: 40 minutes ]strength measurement
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| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Because COPD is generally more common in males, patients of this gender were included in the study. |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526184
| Turkey | |
| Karabük Üniversitesi Araştırma Hastanesi Göğüs Hastalıkları Kliniği | |
| Karabük, Turkey, 78600 | |
| Responsible Party: | Ahmet Gunes, PhD Student, Medipol University |
| ClinicalTrials.gov Identifier: | NCT04526184 |
| Other Study ID Numbers: |
IMU |
| First Posted: | August 25, 2020 Key Record Dates |
| Last Update Posted: | December 29, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |