Effects of Low-Intensity Blood Flow Restriction Training in Normoxia and Hypoxia Conditions

June 10, 2024 updated by: Michal Krzysztofik, The Jerzy Kukuczka Academy of Physical Education in Katowice

Acute and Chronic Effects of Low-Intensity Blood Flow Restriction Training in Normoxia and Hypoxia Conditions on Muscle Strength, Thickness, Catecholamine, and Inflammatory Responses in Physically Active Adults

One approach to significantly reducing resistance training intensity while maintaining effectiveness in muscle mass and strength development involves conducting training sessions under hypoxic conditions. This is likely due to heightened physiological responses. While sports science research indicates a substantial impact of hypoxic conditions on immediate increases in metabolic stress and augmented hormonal responses, recent findings suggest that the role of their influence on skeletal muscle adaptations post-resistance training under hypoxic conditions remains unknown. Additionally, there is a lack of reports on whether the type of hypoxia applied via blood flow restriction or chamber differentiates the increase in secretion of these catecholamines in both immediate and long-term aspects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Śląsk
      • Katowice, Śląsk, Poland, 40-065
        • The Jerzy Kukuczka Academy of Physical Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Regularly physically active (at least 30 mins of structured exercise 3 times per week),
  • Sea-level natives,
  • Experienced in resistance training (at least one year of experience in regular resistance exercise)

Exclusion Criteria:

  • presence of any medical risk factors to exercise and/or exposure to altitude
  • presence of any medical condition that would make the protocol unreasonably hazardous for the participant
  • smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Low-Intensity Normoxia
Participants will be breathing room air, and perform low-intensity lower-body resistance exercise.
Other: low-intensity resistance training
4 sets of 30/15/15/15 repetitions of leg press exercise with a load of 20-30% of one-repetition maximum (weeks 1-3: 20%, weeks 4-6: 30%) in normoxic conditions performed twice a week for 6 weeks.
Active Comparator: High-Intensity Normoxia
Participants will be breathing room air, and perform high-intensity lower-body resistance exercise.
Other: high-intensity resistance training
4 sets of 10 repetitions of leg press exercise at 70-80% one-repetition maximum (weeks 1-3: 70%, weeks 4-6: 80%) in normoxic conditions performed twice a week for 6 weeks.
Experimental: Low-Intensity Normoxia with Blood Flow Restriction
Participants will be breathing room air, and perform low-intensity lower-body resistance exercise combined with blood flow restriction.
Other: low-intensity resistance training combined with blood flow restriction
4 sets of 30/15/15/15 repetitions of leg press exercise with a load of 20-30% of one-repetition maximum (weeks 1-3: 20%, weeks 4-6: 30%) in normoxic conditions with lower-limbs blood flow restriction (80% total occlusion pressure) performed twice a week for 6 weeks.
Experimental: Low-Intensity Hypoxia
Participants will be breathing a 13% oxygen gas mixture, and perform low-intensity lower-body resistance exercise.
Other: low-intensity resistance training in hypoxia condition
4 sets of 30/15/15/15 repetitions of leg press exercise with a load of 20-30% of one-repetition maximum (weeks 1-3: 20%, weeks 4-6: 30%) in hypoxia conditions (3500 meters above sea) performed twice a week for 6 weeks.
Experimental: Low-Intensity Hypoxia with Blood Flow Restriction
Participants will be breathing a 13% oxygen gas mixture, and perform low-intensity lower-body resistance exercise combined with blood flow restriction.
Other: low-intensity resistance training combined with blood flow restriction in hypoxia condition
4 sets of 30/15/15/15 repetitions of leg press exercise with a load of 20-30% of one-repetition maximum (weeks 1-3: 20%, weeks 4-6: 30%) in normobaric hypoxia conditions (3500 meters above sea) with lower-limbs blood flow restriction (80% total occlusion pressure) performed twice a week for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Force Output
Time Frame: Immediately pre and post first and last training session
Force plate will be used to quantify maximum absolute (N) and relative force output (body mass divided per force output in N/kg) during maximum voluntary isometric back squat in a 100ms time frame. Participants will be pushing as hard and as fast as they can on an unmoveable barbell while standing on a force plate.
Immediately pre and post first and last training session
One-Repetition Maximum
Time Frame: within 5 days from the start and end of training
One-Repetition Maximum test in leg press exercise will be performed to quantify maximum lower body dynamic strength (kg). Participants will be performing single repetitions of leg press exercise with increasing load until volitional failure.
within 5 days from the start and end of training
Maximum Number of Repetitions
Time Frame: within 5 days from the start and end of training
A maximum number of repetitions in leg press exercise will be performed to quantify lower body strength endurance (number). Participants will be performing leg press exercise at 50% of one-repetition maximum until volitional failure.
within 5 days from the start and end of training
Countermovement Jump Height
Time Frame: Immediately pre and post first and last training session
Countermovement jump height will be performed estimated via take-off velocity performed on force plates to Participants will perform 3 trials on force plate.
Immediately pre and post first and last training session
Countermovement Jump Power Output
Time Frame: Immediately pre and post first and last training session
Countermovement jump performance will be performed to quantify maximum lower body relative and absolute power-output (W/kg and W), and jump height (cm) with concomitant assessment of contraction depth (cm) and contraction time (ms). Participants will perform 3 trials on force plate.
Immediately pre and post first and last training session
Catecholamine Response
Time Frame: Immediately pre and post first and last training session
A blood sample will be analyzed to quantify changes in epinephrine and norepinephrine level changes.
Immediately pre and post first and last training session
Muscle Stiffness
Time Frame: Immediately pre and post first and last training session
Myotonometry measure will be used to quantify changes in vastus medialis oblique muscle stiffness in N/m
Immediately pre and post first and last training session
Muscle Thickness
Time Frame: within 5 days from the start and end of training
Ultrasonography measure will be used to quantify changes in vastus medialis oblique cross-sectional area.
within 5 days from the start and end of training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perception of Effort
Time Frame: Immediately pre and post every training session
The rate of perceived exertion scale will be used to quantify the perception of effort (units on a scale).
Immediately pre and post every training session
Blood Pressure
Time Frame: Immediately pre and post first and last training session
Systolic and diastolic blood pressure will be measured to quantify blood pressure responses.
Immediately pre and post first and last training session
Perception of Pain
Time Frame: Immediately pre and post every training session
A visual analogue scale will be used to quantify the perception of pain (units on a scale).
Immediately pre and post every training session

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Body Mass
Time Frame: within 5 days from the start and end of training
Dual-energy X-ray absorptiometry will be used to quantify total body mass (kg).
within 5 days from the start and end of training
Percentage Body Fat
Time Frame: within 5 days from the start and end of training
Dual-energy X-ray absorptiometry will be used to quantify the percentage of body fat (%).
within 5 days from the start and end of training
Bone Mass Density
Time Frame: within 5 days from the start and end of training
Dual-energy X-ray absorptiometry will be used to quantify femur bone mass density (g/cm2).
within 5 days from the start and end of training
Bone Mineral Content
Time Frame: within 5 days from the start and end of training
Dual-energy X-ray absorptiometry will be used to quantify bone mineral content (g).
within 5 days from the start and end of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Jerzy Kukuczka Academy of Physical Education in Katowice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SKN/SP/569582/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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