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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04151771
Other study ID # 2019-01641
Secondary ID SNCTP00000350920
Status Completed
Phase N/A
First received
Last updated
Start date December 27, 2019
Est. completion date January 28, 2023

Study information

Verified date April 2023
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 28, 2023
Est. primary completion date January 28, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
Usual outpatient pulmonary rehabilitation
The control group will perform outpatient pulmonary rehabilitation as established.

Locations

Country Name City State
Switzerland University Hospital Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee extensor strength 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)
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