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Trial record 1 of 1 for:    NCT04151771
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Low-load Blood Flow Restriction Training in COPD (LL-BFRT COPD)

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ClinicalTrials.gov Identifier: NCT04151771
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Peripheral muscle weakness is a predominant problem in patients with COPD and treated using exercise training in pulmonary rehabilitation. Despite pulmonary rehabilitation being an effective intervention, muscle strength impairment is a persisting problem in COPD patients. Patients have problems to tolerate the high training loads, which are necessary to develop strength. Low-load blood flow restriction training (LL-BFRT) might therefore be an option to enhance muscular response of patients with COPD to strength training. Up to now, no studies investigating LL-BFRT in respiratory diseases are available.

The primary outcome of this randomized pilot study is knee extensor muscle strength. Secondary, the study will evaluate if LL-BFRT is well tolerated and feasible in COPD patients attending outpatient pulmonary rehabilitation.


Condition or disease Intervention/treatment Phase
COPD Muscle Weakness Other: Low-load blood flow restriction training Other: Usual outpatient pulmonary rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-load Blood Flow Restriction Training in COPD
Estimated Study Start Date : November 8, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: LL-BFRT group
Participants randomised into intervention group are attending pulmonary rehabilitation in which strengthening exercises of the lower limb are performed using LL-BFRT.
Other: Low-load blood flow restriction training
The intervention group will perform the exercises of the lower limbs using LL-BFRT with an occlusion pressure of 70% of arterial occlusion pressure with low training loads (30% of the 1 repetition maximum).
Other Name: LL-BFRT

Active Comparator: Usual pulmonary rehabilitation group
Participants randomised into control group are attending usual pulmonary rehabilitation as established.
Other: Usual outpatient pulmonary rehabilitation
The control group will perform outpatient pulmonary rehabilitation as established.




Primary Outcome Measures :
  1. Knee extensor strength [ Time Frame: during 12 weeks (24 exercise sessions) ]
    Between-group difference in total change in isometric muscle strength of the knee extensor muscles, measured by handheld dynamometry in newtonmeter



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed COPD according to GOLD-guidelines
  • Assigned to outpatient pulmonary rehabilitation by the treating physician

Exclusion Criteria:

  • Physical or intellectual impairment precluding informed consent or protocol adherence
  • Non-German speaking (precluding informed consent)
  • Acute or recent (within the last 6 weeks) exacerbation of COPD
  • Attending a pulmonary rehabilitation program within the last 3 months
  • Pregnant patients
  • History of thromboembolic event in the lower extremity
  • Diagnosis of polyneuropathy
  • Resting systolic blood pressure <100 mmHg

Information from the National Library of Medicine

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): NCT04151771


Contacts
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Contact: Christian F Clarenbach, MD +41 44 255 17 12 christian.clarenbach@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Christian F Clarenbach, MD    +41 44 255 17 12    christian.clarenbach@usz.ch   
Contact: Dario Kohlbrenner, MSc    +41 43 253 08 42    dario.kohlbrenner@usz.ch   
Sponsors and Collaborators
University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04151771     History of Changes
Other Study ID Numbers: 2019-01641
SNCTP000003509 ( Other Identifier: kofam )
2019-01641 ( Other Identifier: KEK-ZH )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
blood flow restriction training
pulmonary rehabilitation
COPD
muscle weakness
Additional relevant MeSH terms:
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Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms