Back to resultsLow-load Blood Flow Restriction Training in COPD (LL-BFRT COPD)
Primary Purpose
COPD, Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Low-load blood flow restriction training
Usual outpatient pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring blood flow restriction training, pulmonary rehabilitation, COPD, muscle weakness
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LL-BFRT group
Usual pulmonary rehabilitation group
Arm Description
Participants randomised into intervention group are attending pulmonary rehabilitation in which strengthening exercises of the lower limb are performed using LL-BFRT.
Participants randomised into control group are attending usual pulmonary rehabilitation as established.
Outcomes
Primary Outcome Measures
Knee extensor strength
Between-group difference in total change in isometric muscle strength of the knee extensor muscles, measured by handheld dynamometry in newtonmeter
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04151771
Brief Title
Low-load Blood Flow Restriction Training in COPD
Acronym
LL-BFRT COPD
Official Title
Low-load Blood Flow Restriction Training in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
January 28, 2023 (Actual)
Study Completion Date
January 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Muscle Weakness
Keywords
blood flow restriction training, pulmonary rehabilitation, COPD, muscle weakness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LL-BFRT group
Arm Type
Experimental
Arm Description
Participants randomised into intervention group are attending pulmonary rehabilitation in which strengthening exercises of the lower limb are performed using LL-BFRT.
Arm Title
Usual pulmonary rehabilitation group
Arm Type
Active Comparator
Arm Description
Participants randomised into control group are attending usual pulmonary rehabilitation as established.
Intervention Type
Other
Intervention Name(s)
Low-load blood flow restriction training
Other Intervention Name(s)
LL-BFRT
Intervention Description
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
Intervention Name(s)
Usual outpatient pulmonary rehabilitation
Intervention Description
The control group will perform outpatient pulmonary rehabilitation as established.
Primary Outcome Measure Information:
Title
Knee extensor strength
Description
Between-group difference in total change in isometric muscle strength of the knee extensor muscles, measured by handheld dynamometry in newtonmeter
Time Frame
during 12 weeks (24 exercise sessions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Low-load Blood Flow Restriction Training in COPD
We'll reach out to this number within 24 hrs