Effects of BFR Interventions in Healthy Individuals and Individuals With COPD

Study Overview
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Brief Summary
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The purpose of the study is to investigate the effect of different blood flow restriction (BFR) interventions on muscle function and adaptations both in healthy well-trained individuals and individuals diagnosed with COPD.

Official Title
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Effects of BFR Interventions on Muscle Function and Adaptations in Healthy Individuals and Individuals With COPD

Conditions
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Healthy, COPD

Intervention / Treatment
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* Other: BFR during training
* Other: BFR during rest


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for participants with COPD group are: Diagnosis with COPD Exclusion criteria participants in the COPD group are Having experienced an acute exacerbation of COPD within the last 6 weeks (Study A) Taking part in pulmonary rehabilitation within the last 3 months (Study A) Presenting with a history of thromboembolic event in the lower limbs. Inclusion criteria for healthy participants are: Age between 18 and 40 years. Maximal oxygen uptake (VO2max) of >55 ml O2/kg/min for men and >50 ml O2/kg/min for women BMI of <26 and normal ECG and blood pressure. Exclusion criteria for healthy participants are: Smoking chronic disease, Use of prescription medication Pain due to current or previous musculoskeletal injury Resistance training more than once per week in the 12 months leading up to the intervention.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFR-ST and BFR-HIT<br>Participants will be allocated to a BFR intervention including resistance training and high-intensity intervals performed on a bicycle ergometer, both performed with BFR. | Other: BFR during training<br>* Healthy participants and participants diagnosed with COPD will be randomized to either the BFR-ST and BFR-HIT or to HL-ST and HIT<br>|
| Active Comparator: HL-ST and HIT<br>Participants will be allocated to heavy load resistance training and high-intensity intervals performed on a bicycle ergometer, both performed without BFR | Other: BFR during training<br>* Healthy participants and participants diagnosed with COPD will be randomized to either the BFR-ST and BFR-HIT or to HL-ST and HIT<br>|
| Experimental: BFR-P<br>Participants with COPD experiencing an acute exacerbation of their COPD requiring hospitalization will be allocated to application of BFR twice daily throughout their hospitalization. Participants are resting in a supine position throughout the application of BFR. | Other: BFR during rest<br>* Participants experiencing acute exacerbation of their COPD requiring hospitalization will be randomized to either BFR-P, BFR-NMES or the control group throughout their hospitalization.<br>|
| Experimental: BFR-NMES<br>Participants with COPD experiencing an acute exacerbation of their COPD requiring hospitalization will be allocated to application of BFR with neuromuscular electrical stimulation (BFR-NMES) twice daily throughout their hospitalization. Participants are resting in a supine position throughout the application of BFR-NMES. | Other: BFR during rest<br>* Participants experiencing acute exacerbation of their COPD requiring hospitalization will be randomized to either BFR-P, BFR-NMES or the control group throughout their hospitalization.<br>|
| Active Comparator: Control group<br>Participants with COPD experiencing an acute exacerbation of their COPD requiring hospitalization will allocated to usual care, consisting of daily physiotherapy sessions. | Other: BFR during rest<br>* Participants experiencing acute exacerbation of their COPD requiring hospitalization will be randomized to either BFR-P, BFR-NMES or the control group throughout their hospitalization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Maximal voluntary isometric contraction of m. quadriceps femoris | Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean mass | Lean mass assessed by dual X-ray absorptiometry (DXA) | Change assessed from before to after the 6 week intervention | 
| Maximal oxygen consumption | VO2max during incremental exercise | Change assessed from before to after the 6 week intervention | 
| Skeletal muscle mitochondrial respiration | High resolution respirometry | Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B) | 
| Fiber cross-sectional area | Immunohistochemistry to determine fiber cross-sectional area | Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B) | 
| Myonuclei | Immunohistochemistry to determine number of myonuclei | Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B) | 
| Functional exercise capacity | Number of repetitions achieved during a 1-minute sit-to-stand test | Change assessed from before to after the 6 week intervention (only in individuals with COPD) | 
| Satellite cells | Immunohistochemistry to determine number of satellite cells | Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BFR, COPD, Exercise