Effects of BFR Interventions in Healthy Individuals and Individuals With COPD

NCT05734534 | Unknown

• 1 other identifier: BFR
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; COPD

Keywords

BFR; COPD; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Lean mass

  Change assessed from before to after the 6 week intervention

• Maximal oxygen consumption

  Change assessed from before to after the 6 week intervention

• Skeletal muscle mitochondrial respiration

  Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)

• 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

  Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)

Study Arms (5)

BFR-ST and BFR-HIT

EXPERIMENTAL

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

HL-ST and HIT

ACTIVE COMPARATOR

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

BFR-P

EXPERIMENTAL

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

BFR-NMES

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

BFR during training OTHER

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-ST and BFR-HIT; HL-ST and HIT

BFR during rest OTHER

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.

BFR-NMES; BFR-P; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis with COPD

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Morten Hostrup, PhD: lead

Study Sites (1)

August Krogh Building

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Morten Hostrup

CONTACT

+4535321595; mhostrup@nexs.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: February 21, 2023
• Study Start: March 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

DK (1)