NCT04521959

Brief Summary

Patients with chronic obstructive pulmonary disease (COPD) classified by a pulmonologist in accordance with the GOLD criteria will be randomly divided into 2 groups. The first group (n = 20) was accompanied by blood flow restriction (CAC), 3 times a week, 8 weeks, 1RMx 30% intensity, 10 repetitions, 3 sets, 30 seconds rest interval, progressive resistance exercise (PRE) and after 5 minutes of rest by cycling. Progressive aerobic exercise (AE) (BFR PRE + AE group) in the target heart rate range of 50-80% intensity will be applied to the second group (n = 20), PRE and AE (PRE + AE group) performed at the same intensity and duration without BFR.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

August 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2021

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

August 18, 2020

Last Update Submit

April 13, 2025

Conditions

Keywords

COPD, blood flow restriction, exercise

Outcome Measures

Primary Outcomes (12)

  • FEV1/FVC rate

    respiratory function test

    eight weeks

  • creatine kinase

    muscle breakdown marker

    eight weeks

  • c reactive protein

    thrombus formation risk marker

    eight weeks

  • d-dimer

    venous thromboembolism marker

    eight weeks

  • total antioxidant status

    oxidative stress marker

    eight weeks

  • total oxidant status

    oxidative stress marker

    eight weeks

  • interleukin 6

    inflammation marker

    eight weeks

  • oxygen saturation

    blood gas test

    three times a week

  • heart rate

    for exercise dose determination

    three times a week

  • six minute walk test

    strength evaluation

    eight weeks

  • ST george's respiratory questionnaire

    used to evaluate the effects of respiratory disease's symptoms and illness

    eight weeks

  • quadriceps muscle diameter

    Measurement of change in muscle volume

    eight weeks

Study Arms (2)

Blood Flow Restricted Aerobic and Resistance Exercise Group

ACTIVE COMPARATOR

kan akımı kısıtlanarak.direnç ve bisikletle aerobik egzersiz uygulanacak

Procedure: Blood flow restricted and normal aerobic exercise and resistance exercise

Normal aerobik ve direnç egzersiz grubu

ACTIVE COMPARATOR

Normal şartlarda aerobik ve direnç egzersizi uygulanacak

Procedure: Blood flow restricted and normal aerobic exercise and resistance exercise

Interventions

Interventions of the same duration and intensity will be applied to two groups.

Blood Flow Restricted Aerobic and Resistance Exercise GroupNormal aerobik ve direnç egzersiz grubu

Eligibility Criteria

Age40 Years - 78 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSince COPD affects male gender more, the number of male patients participating in the intervention is higher than female patients.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with mild to severe COPD according to GOLD criteria in the age range of 40-78
  • No drug change for at least 30 days
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabük Üniversitesi Araştırma Hastanesi Göğüs Hastalıkları Kliniği

Karabük, Karabük Province, 78600, Turkey (Türkiye)

Location

Related Publications (8)

  • 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: 31156448BACKGROUND
  • 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: 31684769BACKGROUND
  • 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: 25430600BACKGROUND
  • 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: 21385216BACKGROUND
  • 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: 25338316BACKGROUND
  • 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: 23446173BACKGROUND
  • 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: 21436993BACKGROUND
  • Wilk M, Krzysztofik M, Gepfert M, Poprzecki S, Golas A, Maszczyk A. Technical and Training Related Aspects of Resistance Training Using Blood Flow Restriction in Competitive Sport - A Review. J Hum Kinet. 2018 Dec 31;65:249-260. doi: 10.2478/hukin-2018-0101. eCollection 2018 Dec.

    PMID: 30687436BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
40 COPD patients will be randomised divided into two equal groups according to age, gender and disease severity.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two randomized controlled intervention groups will be formed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 21, 2020

Study Start

August 19, 2020

Primary Completion

February 23, 2021

Study Completion

May 25, 2021

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations