Hypoxia, AltitudeNCT06171841
Effects of Low-Intensity Blood Flow Restriction Training in Normoxia and Hypoxia Conditions
A study testing low-intensity resistance training, high-intensity resistance training and low-intensity resistance training combined with blood flow restriction in people with Hypoxia, Altitude and Blood Flow Restriction, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Altitude, Blood Flow Restriction, Resistance Training
- What is being tested?
- low-intensity resistance training, high-intensity resistance training and low-intensity resistance training combined with blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 20 Nov 2023to 1 Jul 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Jerzy Kukuczka Academy of Physical Education
Katowice, Silesian Voivodeship, 40-065
About this study
Official title: 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.
- Being tested
- low-intensity resistance training, high-intensity resistance training, low-intensity resistance training combined with blood flow restriction, low-intensity resistance training in hypoxia condition, low-intensity resistance training combined with blood flow restriction in hypoxia condition
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-intensity resistance trainingOther
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.
high-intensity resistance trainingOther
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.
low-intensity resistance training combined with blood flow restrictionOther
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.
low-intensity resistance training in hypoxia conditionOther
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.
low-intensity resistance training combined with blood flow restriction in hypoxia conditionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity Normoxia | Active comparator | Participants will be breathing room air, and perform low-intensity lower-body resistance exercise. Receives: Other: low-intensity resistance training |
| High-Intensity Normoxia | Active comparator | Participants will be breathing room air, and perform high-intensity lower-body resistance exercise. Receives: Other: high-intensity resistance training |
| Low-Intensity Normoxia with Blood Flow Restriction | Experimental | Participants will be breathing room air, and perform low-intensity lower-body resistance exercise combined with blood flow restriction. Receives: Other: low-intensity resistance training combined with blood flow restriction |
| Low-Intensity Hypoxia | Experimental | Participants will be breathing a 13% oxygen gas mixture, and perform low-intensity lower-body resistance exercise. Receives: Other: low-intensity resistance training in hypoxia condition |
| Low-Intensity Hypoxia with Blood Flow Restriction | Experimental | Participants will be breathing a 13% oxygen gas mixture, and perform low-intensity lower-body resistance exercise combined with blood flow restriction. Receives: Other: low-intensity resistance training combined with blood flow restriction in hypoxia condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force Output
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.
Measured: Immediately pre and post first and last training session
One-Repetition Maximum
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.
Measured: within 5 days from the start and end of training
Maximum Number of Repetitions
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.
Measured: within 5 days from the start and end of training
Countermovement Jump Height
Countermovement jump height will be performed estimated via take-off velocity performed on force plates to Participants will perform 3 trials on force plate.
Measured: Immediately pre and post first and last training session
Countermovement Jump Power Output
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.
Measured: Immediately pre and post first and last training session
Catecholamine Response
A blood sample will be analyzed to quantify changes in epinephrine and norepinephrine level changes.
Measured: Immediately pre and post first and last training session
Muscle Stiffness
Myotonometry measure will be used to quantify changes in vastus medialis oblique muscle stiffness in N/m
Measured: Immediately pre and post first and last training session
Muscle Thickness
Ultrasonography measure will be used to quantify changes in vastus medialis oblique cross-sectional area.
Measured: within 5 days from the start and end of training
Secondary outcomes (3)
Perception of Pain
A visual analogue scale will be used to quantify the perception of pain (units on a scale).
Measured: Immediately pre and post every training session
Perception of Effort
The rate of perceived exertion scale will be used to quantify the perception of effort (units on a scale).
Measured: Immediately pre and post every training session
Blood Pressure
Systolic and diastolic blood pressure will be measured to quantify blood pressure responses.
Measured: Immediately pre and post first and last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start20 Nov 2023
- Primary completion20 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia, AltitudeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Krzysztofik, The Jerzy Kukuczka Academy of Physical Education in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171841
- Sponsor's protocol ID
- SKN/SP/569582/2023
- Status last verified
- Jun 2024
- First submitted
- 25 Nov 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06171841
- Acronym / sponsor ID
- SKN/SP/569582/2023
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 15 Dec 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity Normoxia | Active comparator | Other: low-intensity resistance trainingParticipants will be breathing room air, and perform low-intensity lower-body resistance exercise. |
| High-Intensity Normoxia | Active comparator | Other: high-intensity resistance trainingParticipants will be breathing room air, and perform high-intensity lower-body resistance exercise. |
| Low-Intensity Normoxia with Blood Flow Restriction | Experimental | Other: low-intensity resistance training combined with blood flow restrictionParticipants will be breathing room air, and perform low-intensity lower-body resistance exercise combined with blood flow restriction. |
| Low-Intensity Hypoxia | Experimental | Other: low-intensity resistance training in hypoxia conditionParticipants will be breathing a 13% oxygen gas mixture, and perform low-intensity lower-body resistance exercise. |
| Low-Intensity Hypoxia with Blood Flow Restriction | Experimental | Other: low-intensity resistance training combined with blood flow restriction in hypoxia conditionParticipants will be breathing a 13% oxygen gas mixture, and perform low-intensity lower-body resistance exercise combined with blood flow restriction. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| low-intensity resistance training4 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. | Other | Low-Intensity Normoxia |
| high-intensity resistance training4 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. | Other | High-Intensity Normoxia |
| low-intensity resistance training combined with blood flow restriction4 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. | Other | Low-Intensity Normoxia with Blood Flow Restriction |
| low-intensity resistance training in hypoxia condition4 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. | Other | Low-Intensity Hypoxia |
| low-intensity resistance training combined with blood flow restriction in hypoxia condition4 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. | Other | Low-Intensity Hypoxia with Blood Flow Restriction |
Primary outcome
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.
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.
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.
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.
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.
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.
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
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.
3 secondary outcomes
Perception of Pain
Time frame: Immediately pre and post every training session
Perception of Effort
Time frame: Immediately pre and post every training session
Blood Pressure
Time frame: Immediately pre and post first and last training session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-intensity resistance training, high-intensity resistance training and low-intensity resistance training combined with blood flow restriction in people with Hypoxia, Altitude and Blood Flow Restriction, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
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 3 inclusion and 3 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 11 Jun 2024. 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 Poland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force Output (time frame: Immediately pre and post first and last training session). The study lists 8 primary outcomes in all. 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 11 Jun 2024.