Effects of BFR Interventions in Healthy Individuals and Individuals With COPD

NCT ID: NCT05734534

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-08-01

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.

Detailed Description

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Conditions

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Healthy COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

BFR during training

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

BFR during training

Intervention Type 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-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.

Group Type EXPERIMENTAL

BFR during rest

Intervention Type 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

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.

Group Type EXPERIMENTAL

BFR during rest

Intervention Type 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.

Control group

Participants with COPD experiencing an acute exacerbation of their COPD requiring hospitalization will allocated to usual care, consisting of daily physiotherapy sessions.

Group Type ACTIVE_COMPARATOR

BFR during rest

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis with COPD


* 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

* 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.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Morten Hostrup, PhD

OTHER

Sponsor Role lead

Responsible Party

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Morten Hostrup, PhD

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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August Krogh Building

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Morten Hostrup

Role: CONTACT

+4535321595

Facility Contacts

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Morten Hostrup

Role: primary

+4535321595

Other Identifiers

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BFR

Identifier Type: -

Identifier Source: org_study_id

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