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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 : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE October 31, 2019
First Posted Date  ICMJE November 5, 2019
Last Update Posted Date February 23, 2021
Actual Study Start Date  ICMJE December 27, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-load Blood Flow Restriction Training in COPD
Official Title  ICMJE Low-load Blood Flow Restriction Training in COPD
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Muscle Weakness
Intervention  ICMJE
  • 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
  • Other: Usual outpatient pulmonary rehabilitation
    The control group will perform outpatient pulmonary rehabilitation as established.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Low-load blood flow restriction training
  • Active Comparator: Usual pulmonary rehabilitation group
    Participants randomised into control group are attending usual pulmonary rehabilitation as established.
    Intervention: Other: Usual outpatient pulmonary rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christian F Clarenbach, MD +41 44 255 17 12 christian.clarenbach@usz.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04151771
Other Study ID Numbers  ICMJE 2019-01641
SNCTP000003509 ( Other Identifier: kofam )
2019-01641 ( Other Identifier: KEK-ZH )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Zurich
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP