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

NCT04526184 | Enrolling By Invitation

• 1 other identifier: IMU
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (7)

• creatine kinase

  rhabdomyolysis marker

  30 minutes

• C reactive protein, neutrophil

  inflammatory marker

  30 minutes

• oxygen saturation

  blood oxygen saturation

  30 minutes

• heart rate

  determination of aerobic exercise dose

  30 minutes

• systolic and diastolic pressure

  to mean arterial pressure calculation

  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.

  up to 18 weeks.

• oxidative stress markers

  uric acid, lactate dehydrogenase

  up to 18 weeks

Study Arms (2)

healthy group

ACTIVE COMPARATOR

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

patient group

ACTIVE COMPARATOR

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

Procedure: aerobic exercise with blood flow restriction

Interventions

aerobic exercise with blood flow restriction PROCEDURE

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

healthy group; patient group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Because COPD is generally more common in males, patients of this gender were included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Karabük Üniversitesi Araştırma Hastanesi Göğüs Hastalıkları Kliniği

Karabük, 78600, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 31156448 RESULT

• 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.

  PMID: 21385216 RESULT

• 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.

  PMID: 25430600 RESULT

• 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.

  PMID: 31684769 RESULT

• 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.

  PMID: 25338316 RESULT

• 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.

  PMID: 23446173 RESULT

• 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.

  PMID: 21436993 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

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

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 25, 2020
• Study Start: August 17, 2020
• Primary Completion: March 19, 2024
• Study Completion: April 15, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)