Effects of BFR Interventions in Healthy Individuals and Individuals With COPD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; COPD
• Intervention / Treatment: Other: BFR during training; Other: BFR during rest

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Morten Hostrup; Phone Number: +4535321595; Email: mhostrup@nexs.ku.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • August Krogh Building
    • Contact: Morten Hostrup; Phone Number: +4535321595; Email: mhostrup@nexs.ku.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BFR-ST and BFR-HIT; 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; Healthy participants and participants diagnosed with COPD will be randomized to either the BFR-ST and BFR-HIT or to HL-ST and HIT
Active Comparator: HL-ST and HIT; 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; Healthy participants and participants diagnosed with COPD will be randomized to either the BFR-ST and BFR-HIT or to HL-ST and HIT
Experimental: BFR-P; 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; 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.
Experimental: BFR-NMES; 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; 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.
Active Comparator: Control group; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Morten Hostrup, PhD

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Estimate): February 20, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; COPD; BFR
• Other Study ID Numbers: BFR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No