Low-load Blood Flow Restriction Training in COPD (LL-BFRT COPD)

April 11, 2023 updated by: University of Zurich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during 12 weeks (24 exercise sessions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2019

Primary Completion (Actual)

January 28, 2023

Study Completion (Actual)

January 28, 2023

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-01641 (Other Identifier: KEK-ZH)
  • SNCTP000003509 (Other Identifier: kofam)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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