COPDNCT04526184
Systemic Effects of A Continuous Blood Flow Restricted Aerobic Exercise Session in COPD Patients: A Randomised Controlled Trial.
A study testing aerobic exercise with blood flow restriction in people with COPD, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- aerobic exercise with blood flow restriction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2020to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabük Üniversitesi Araştırma Hastanesi Göğüs Hastalıkları Kliniği
Karabük, 78600
About this study
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.
Read the 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.
- Conditions
- COPD
- Being tested
- aerobic exercise with blood flow restriction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise with blood flow restrictionProcedure or surgery
Patients and healthy individuals will be given 30 minutes of aerobic exercise by cycling, by restricting lower extremity blood flow.
| Study group | Role | What they receive |
|---|---|---|
| healthy group | Active comparator | 25 healthy individuals between the ages of 40-70 will be contacted by phone and included in the initiative. Receives: Procedure: aerobic exercise with blood flow restriction |
| patient group | Active comparator | 25 individuals will be selected randomly from 103 patients with COPD from hospital records. Receives: Procedure: aerobic exercise with blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
creatine kinase
rhabdomyolysis marker
Measured: 30 minutes
C reactive protein, neutrophil
inflammatory marker
Measured: 30 minutes
oxygen saturation
blood oxygen saturation
Measured: 30 minutes
heart rate
determination of aerobic exercise dose
Measured: 30 minutes
systolic and diastolic pressure
to mean arterial pressure calculation
Measured: up to 18 weeks
modified borg scale
dyspnoea measurement, Minimum 1, maximum 7 points are obtained. 5 indicates the best respiratory condition, 10 the worst respiratory condition.
Measured: up to 18 weeks.
oxidative stress markers
uric acid, lactate dehydrogenase
Measured: up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start17 Aug 2020
- Primary completion19 Mar 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will be formed as healthy and patient groups and the same treatment initiative will be applied.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Gunes, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526184
- Sponsor's protocol ID
- IMU
- Status last verified
- Mar 2024
- First submitted
- 18 Aug 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
PubMed 31156448Kacin A, Strazar K. Frequent low-load ischemic resistance exercise to failure enhances muscle oxygen delivery and endurance capacity. Scand J Med Sci Sports. 2011 Dec;21(6):e231-41. doi: 10.1111/j.1600-0838.2010.01260.x. Epub 2011 Mar 8.
PubMed 21385216Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1.
PubMed 25430600Nolan CM, Rochester CL. Exercise Training Modalities for People with Chronic Obstructive Pulmonary Disease. COPD. 2019 Dec;16(5-6):378-389. doi: 10.1080/15412555.2019.1637834. Epub 2019 Nov 4.
PubMed 31684769Loenneke JP, Allen KM, Mouser JG, Thiebaud RS, Kim D, Abe T, Bemben MG. Blood flow restriction in the upper and lower limbs is predicted by limb circumference and systolic blood pressure. Eur J Appl Physiol. 2015 Feb;115(2):397-405. doi: 10.1007/s00421-014-3030-7. Epub 2014 Oct 22.
PubMed 25338316Wilson JM, Lowery RP, Joy JM, Loenneke JP, Naimo MA. Practical blood flow restriction training increases acute determinants of hypertrophy without increasing indices of muscle damage. J Strength Cond Res. 2013 Nov;27(11):3068-75. doi: 10.1519/JSC.0b013e31828a1ffa.
PubMed 23446173Berzosa C, Cebrian I, Fuentes-Broto L, Gomez-Trullen E, Piedrafita E, Martinez-Ballarin E, Lopez-Pingarron L, Reiter RJ, Garcia JJ. Acute exercise increases plasma total antioxidant status and antioxidant enzyme activities in untrained men. J Biomed Biotechnol. 2011;2011:540458. doi: 10.1155/2011/540458. Epub 2011 Mar 9.
PubMed 21436993
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Effects of A Continuous Blood Flow Restricted Aerobic Exercise Session in COPD Patients: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04526184
- Acronym / sponsor ID
- IMU
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 19 Mar 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups will be formed as healthy and patient groups and the same treatment initiative will be applied.
| Arm | Type | Receives |
|---|---|---|
| healthy group | Active comparator | Procedure: aerobic exercise with blood flow restriction25 healthy individuals between the ages of 40-70 will be contacted by phone and included in the initiative. |
| patient group | Active comparator | Procedure: aerobic exercise with blood flow restriction25 individuals will be selected randomly from 103 patients with COPD from hospital records. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise with blood flow restrictionPatients and healthy individuals will be given 30 minutes of aerobic exercise by cycling, by restricting lower extremity blood flow. | Procedure or surgery | healthy group, patient group |
Primary outcome
creatine kinase
Time frame: 30 minutes
rhabdomyolysis marker
C reactive protein, neutrophil
Time frame: 30 minutes
inflammatory marker
oxygen saturation
Time frame: 30 minutes
blood oxygen saturation
heart rate
Time frame: 30 minutes
determination of aerobic exercise dose
systolic and diastolic pressure
Time frame: up to 18 weeks
to mean arterial pressure calculation
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.
oxidative stress markers
Time frame: up to 18 weeks
uric acid, lactate dehydrogenase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Results publication: PubMed 31156448Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
- Results publication: PubMed 21385216Kacin A, Strazar K. Frequent low-load ischemic resistance exercise to failure enhances muscle oxygen delivery and endurance capacity. Scand J Med Sci Sports. 2011 Dec;21(6):e231-41. doi: 10.1111/j.1600-0838.2010.01260.x. Epub 2011 Mar 8.
- Results publication: PubMed 25430600Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1.
- Results publication: PubMed 31684769Nolan CM, Rochester CL. Exercise Training Modalities for People with Chronic Obstructive Pulmonary Disease. COPD. 2019 Dec;16(5-6):378-389. doi: 10.1080/15412555.2019.1637834. Epub 2019 Nov 4.
- Results publication: PubMed 25338316Loenneke JP, Allen KM, Mouser JG, Thiebaud RS, Kim D, Abe T, Bemben MG. Blood flow restriction in the upper and lower limbs is predicted by limb circumference and systolic blood pressure. Eur J Appl Physiol. 2015 Feb;115(2):397-405. doi: 10.1007/s00421-014-3030-7. Epub 2014 Oct 22.
- Results publication: PubMed 23446173Wilson JM, Lowery RP, Joy JM, Loenneke JP, Naimo MA. Practical blood flow restriction training increases acute determinants of hypertrophy without increasing indices of muscle damage. J Strength Cond Res. 2013 Nov;27(11):3068-75. doi: 10.1519/JSC.0b013e31828a1ffa.
- Results publication: PubMed 21436993Berzosa C, Cebrian I, Fuentes-Broto L, Gomez-Trullen E, Piedrafita E, Martinez-Ballarin E, Lopez-Pingarron L, Reiter RJ, Garcia JJ. Acute exercise increases plasma total antioxidant status and antioxidant enzyme activities in untrained men. J Biomed Biotechnol. 2011;2011:540458. doi: 10.1155/2011/540458. Epub 2011 Mar 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise with blood flow restriction in people with COPD, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
creatine kinase (time frame: 30 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04526184, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.