CClinicalTrials.gg
Enrolling by invitationNCT04526184Updated Mar 20, 2024

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

An interventional study of aerobic exercise with blood flow restriction in COPD, sponsored by Medipol University. Enrolling by invitation at 1 site in Turkey. Open to male participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-20.

Sponsored by Medipol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 6 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
Male
01

Study 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.

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.

02

Conditions studied

  • COPD
03

In context

Lead sponsor

Medipol University is the lead sponsor of 311 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
Male
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Active comparator
    healthy group

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

    Procedure: aerobic exercise with blood flow restriction

  • Active comparator
    patient group

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

    Procedure: aerobic exercise with blood flow restriction

Interventions

  • Procedureaerobic 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.

06

What researchers measure

Primary outcomes

  1. creatine kinase

    rhabdomyolysis marker

    Time frame: 30 minutes

  2. C reactive protein, neutrophil

    inflammatory marker

    Time frame: 30 minutes

  3. oxygen saturation

    blood oxygen saturation

    Time frame: 30 minutes

  4. heart rate

    determination of aerobic exercise dose

    Time frame: 30 minutes

  5. systolic and diastolic pressure

    to mean arterial pressure calculation

    Time frame: up to 18 weeks

  6. modified borg scale

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

    Time frame: up to 18 weeks.

  7. oxidative stress markers

    uric acid, lactate dehydrogenase

    Time frame: up to 18 weeks

07

Study locations

1 site
  • Karabük Üniversitesi Araştırma Hastanesi Göğüs Hastalıkları Kliniği
    Karabük, 78600, Turkey
08

References and documents

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. Erratum In: Front Physiol. 2019 Oct 22;10:1332. doi: 10.3389/fphys.2019.01332. PubMed 31156448 ↗
  • Kacin 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 21385216 ↗
  • Scott 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 25430600 ↗
  • Nolan 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 31684769 ↗
  • Loenneke 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 25338316 ↗
  • Wilson 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 23446173 ↗
  • Berzosa 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04526184
Lead sponsor
Medipol University
Responsible party
Ahmet Gunes (PhD Student, Medipol University) — Principal investigator
First posted
Aug 25, 2020
Start date
Aug 17, 2020
Primary completion
Mar 19, 2024 (estimated)
Completion
Apr 15, 2024 (estimated)
Last update
Mar 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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