Low-load Blood Flow Restriction Training in COPD

Study Overview
=================
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.

Official Title
-----------------
Low-load Blood Flow Restriction Training in COPD

Conditions
-----------------
COPD, Muscle Weakness

Intervention / Treatment
-----------------
* Other: Low-load blood flow restriction training
* Other: Usual outpatient pulmonary rehabilitation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LL-BFRT group<br>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<br>* 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).<br>* Other names: LL-BFRT;|
| Active Comparator: Usual pulmonary rehabilitation group<br>Participants randomised into control group are attending usual pulmonary rehabilitation as established. | Other: Usual outpatient pulmonary rehabilitation<br>* The control group will perform outpatient pulmonary rehabilitation as established.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood flow restriction training, pulmonary rehabilitation, COPD, muscle weakness