COPDLL-BFRT COPDNCT04151771
Low-load Blood Flow Restriction Training in COPD
A study testing Low-load blood flow restriction training and Usual outpatient pulmonary rehabilitation in people with COPD and Muscle Weakness, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Muscle Weakness
- What is being tested?
- Low-load blood flow restriction training and Usual outpatient pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Dec 2019to 28 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed COPD according to GOLD-guidelines
- Assigned to outpatient pulmonary rehabilitation by the treating physician
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- COPD, Muscle Weakness
- Being tested
- Low-load blood flow restriction training, Usual outpatient pulmonary rehabilitation
- Keywords
- blood flow restriction training, pulmonary rehabilitation, COPD, muscle weakness
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-load blood flow restriction trainingOther
Also called LL-BFRT
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 rehabilitationOther
The control group will perform outpatient pulmonary rehabilitation as established.
| Study group | Role | What they receive |
|---|---|---|
| LL-BFRT group | Experimental | Participants randomised into intervention group are attending pulmonary rehabilitation in which strengthening exercises of the lower limb are performed using LL-BFRT. Receives: Other: Low-load blood flow restriction training |
| Usual pulmonary rehabilitation group | Active comparator | Participants randomised into control group are attending usual pulmonary rehabilitation as established. Receives: Other: Usual outpatient pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee extensor strength
Between-group difference in total change in isometric muscle strength of the knee extensor muscles, measured by handheld dynamometry in newtonmeter
Measured: during 12 weeks (24 exercise sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start27 Dec 2019
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151771
- Sponsor's protocol ID
- 2019-01641
- Other IDs
- SNCTP000003509, 2019-01641, 2019
- Acronym
- LL-BFRT COPD
- Status last verified
- Apr 2023
- First submitted
- 31 Oct 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38129116
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-load Blood Flow Restriction Training in COPD
- ClinicalTrials.gov ID
- NCT04151771
- Acronym / sponsor ID
- LL-BFRT COPD / 2019-01641
- Conditions
- COPD, Muscle Weakness
- Keywords
- blood flow restriction training, pulmonary rehabilitation, COPD, muscle weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LL-BFRT group | Experimental | Other: Low-load blood flow restriction trainingParticipants randomised into intervention group are attending pulmonary rehabilitation in which strengthening exercises of the lower limb are performed using LL-BFRT. |
| Usual pulmonary rehabilitation group | Active comparator | Other: Usual outpatient pulmonary rehabilitationParticipants randomised into control group are attending usual pulmonary rehabilitation as established. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed COPD according to GOLD-guidelines
- Assigned to outpatient pulmonary rehabilitation by the treating physician
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-load blood flow restriction trainingAlso: LL-BFRTThe 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 | LL-BFRT group |
| Usual outpatient pulmonary rehabilitationThe control group will perform outpatient pulmonary rehabilitation as established. | Other | Usual pulmonary rehabilitation group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 38129116Kohlbrenner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-load blood flow restriction training and Usual outpatient pulmonary rehabilitation in people with COPD and Muscle Weakness, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee extensor strength (time frame: during 12 weeks (24 exercise sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.