HealthyNCT05734534
Effects of BFR Interventions in Healthy Individuals and Individuals With COPD
A study testing BFR during training and BFR during rest in people with Healthy and COPD, run by Morten Hostrup, PhD at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- BFR during training and BFR during rest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
August Krogh Building
Copenhagen, 2100
Morten Hostrup, +4535321595, mhostrup@nexs.ku.dk
About this study
Official title: 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.
- Being tested
- BFR during training, BFR during rest
- Keywords
- BFR, COPD, Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR during trainingOther
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 restOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: Other: BFR during rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Maximal voluntary isometric contraction of m. quadriceps femoris
Measured: 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
Lean mass assessed by dual X-ray absorptiometry (DXA)
Measured: Change assessed from before to after the 6 week intervention
Maximal oxygen consumption
VO2max during incremental exercise
Measured: Change assessed from before to after the 6 week intervention
Skeletal muscle mitochondrial respiration
High resolution respirometry
Measured: 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
Measured: 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
Measured: 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
Measured: Change assessed from before to after the 6 week intervention (only in individuals with COPD)
Satellite cells
Immunohistochemistry to determine number of satellite cells
Measured: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morten Hostrup, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734534
- Sponsor's protocol ID
- BFR
- Status last verified
- Feb 2023
- First submitted
- 23 Dec 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of BFR Interventions on Muscle Function and Adaptations in Healthy Individuals and Individuals With COPD
- ClinicalTrials.gov ID
- NCT05734534
- Acronym / sponsor ID
- BFR
- Keywords
- BFR, COPD, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Morten Hostrup, PhDUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BFR-ST and BFR-HIT | Experimental | Other: BFR during trainingParticipants will be allocated to a BFR intervention including resistance training and high-intensity intervals performed on a bicycle ergometer, both performed with BFR. |
| HL-ST and HIT | Active comparator | Other: BFR during trainingParticipants will be allocated to heavy load resistance training and high-intensity intervals performed on a bicycle ergometer, both performed without BFR |
| BFR-P | Experimental | Other: BFR during restParticipants 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. |
| BFR-NMES | Experimental | Other: BFR during restParticipants 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. |
| Control group | Active comparator | Other: BFR during restParticipants with COPD experiencing an acute exacerbation of their COPD requiring hospitalization will allocated to usual care, consisting of daily physiotherapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFR during trainingHealthy participants and participants diagnosed with COPD will be randomized to either the BFR-ST and BFR-HIT or to HL-ST and HIT | Other | BFR-ST and BFR-HIT, HL-ST and HIT |
| BFR during restParticipants experiencing acute exacerbation of their COPD requiring hospitalization will be randomized to either BFR-P, BFR-NMES or the control group throughout their hospitalization. | Other | BFR-NMES, BFR-P, Control group |
Primary outcome
Muscle strength
Time frame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
Maximal voluntary isometric contraction of m. quadriceps femoris
7 secondary outcomes
Lean mass
Time frame: Change assessed from before to after the 6 week intervention
Maximal oxygen consumption
Time frame: Change assessed from before to after the 6 week intervention
Skeletal muscle mitochondrial respiration
Time frame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
Fiber cross-sectional area
Time frame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
Myonuclei
Time frame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
Functional exercise capacity
Time frame: Change assessed from before to after the 6 week intervention (only in individuals with COPD)
Satellite cells
Time frame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR during training and BFR during rest in people with Healthy and COPD, run by Morten Hostrup, PhD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten Hostrup (+4535321595, mhostrup@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.