- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06171841
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
Active, not recruiting
Intervention / Treatment
- Other: low-intensity resistance training
- Other: high-intensity resistance training
- Other: low-intensity resistance training combined with blood flow restriction
- Other: low-intensity resistance training in hypoxia condition
- Other: low-intensity resistance training combined with blood flow restriction in hypoxia condition
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- 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
-
-
Śląsk
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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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Low-Intensity Normoxia
Participants will be breathing room air, and perform low-intensity lower-body resistance exercise.
|
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.
|
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.
|
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.
|
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.
|
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
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.
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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
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
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 (%).
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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).
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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.
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)
November 20, 2023
Primary Completion (Estimated)
June 20, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
November 25, 2023
First Submitted That Met QC Criteria
December 6, 2023
First Posted (Actual)
December 15, 2023
Study Record Updates
Last Update Posted (Actual)
June 11, 2024
Last Update Submitted That Met QC Criteria
June 10, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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