Effects of BFR Interventions in Healthy Individuals and Individuals With COPD

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734534
• Other study ID #: BFR
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2023
• Source: University of Copenhagen
• Contact: Morten Hostrup
• Phone: +4535321595
• Email: mhostrup[@]nexs.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: August 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Healthy

Intervention

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
• 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.

Locations

Country	Name	City	State
Denmark	August Krogh Building	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Morten Hostrup, PhD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lean mass	Lean mass assessed by dual X-ray absorptiometry (DXA)	Change assessed from before to after the 6 week intervention
Secondary	Maximal oxygen consumption	VO2max during incremental exercise	Change assessed from before to after the 6 week intervention
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)