Low-load Blood Flow Restriction Training in COPD

NCT ID: NCT04151771

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-27

Study Completion Date

2023-01-28

Brief Summary

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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

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Conditions

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COPD Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Low-load blood flow restriction training

Intervention Type OTHER

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 pulmonary rehabilitation group

Participants randomised into control group are attending usual pulmonary rehabilitation as established.

Group Type ACTIVE_COMPARATOR

Usual outpatient pulmonary rehabilitation

Intervention Type OTHER

The control group will perform outpatient pulmonary rehabilitation as established.

Interventions

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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).

Intervention Type OTHER

Usual outpatient pulmonary rehabilitation

The control group will perform outpatient pulmonary rehabilitation as established.

Intervention Type OTHER

Other Intervention Names

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LL-BFRT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Kohlbrenner D, Kuhn M, Manettas A, Aregger C, Peterer M, Greco N, Sievi NA, Clarenbach C. Low-load blood flow restriction strength training in patients with COPD: a randomised single-blind pilot study. Thorax. 2024 Mar 15;79(4):340-348. doi: 10.1136/thorax-2023-220546.

Reference Type DERIVED
PMID: 38129116 (View on PubMed)

Other Identifiers

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SNCTP000003509

Identifier Type: OTHER

Identifier Source: secondary_id

2019-01641

Identifier Type: OTHER

Identifier Source: secondary_id

2019-01641

Identifier Type: -

Identifier Source: org_study_id

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