HypoxiaNCT06226168
Effects of Normobaric Hypoxia Exercise Program on Bone Turnover Markers and Metabolism in Premenopausal Women
A study testing exercise and environmental conditions in people with Hypoxia, run by University School of Physical Education, Krakow, Poland at 2 sites in Poland.
Trial summary
The impact of a proprietary training program in normobaric hypoxia on changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women falls within the realm of physical culture for an active and healthy society. Read more about this study
- Who is it for?
- Ages 50 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- exercise and environmental conditions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPoland
- Study dates
- 7 May 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No significant cardiovascular, respiratory system diseases and musculoskeletal system,
- No contraindications to physical activity. ECG, baseline urinalysis, morphology are required.
- T-score within normal limits (+1.0 to -1.0).
- Informed consent of the patient to participate in the study.
Who cannot join
- Use of hormone replacement therapy (HRT).
- Use of substances (cigarettes, alcohol).
- Any training (including hypoxia training or exposure) performed in the 6 months prior to the beginning of the intervention
- Any other factors determined by the study investigators as unsuitable for participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Małgorzata Bagińska, MSc contact
Poland2 sites, 2 recruiting
- Not yet recruiting
University School of Physical Education in Cracow
Krakow, 31-571
Anna Radoń, MSc, +45126831142, anna.radon@awf.krakow.pl
- Recruiting
University School of Physical Education in Cracow
Krakow, 31-571
Anna Radon, Msc, 48 12 6831142, anna.radon@awf.krakow.pl
About this study
Official title: Effect of the Author's Training Program in Normobaric Hypoxia on Changes in Bone Turnover Markers and Carbohydrate and Lipid Metabolism in Premenopausal Women
The impact of a proprietary training program in normobaric hypoxia on changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women falls within the realm of physical culture for an active and healthy society. Within this context, the implementation of a project is supported aiming to:
- Monitor, support, and promote physical development, fitness, and physical activity in society, by assessing the effects of a proprietary training program in normobaric hypoxia on changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women.
- Develop and implement innovative methods, forms, and means of physical activation and training for individuals of various ages, by formulating general assumptions of an endurance-strength training concept under normobaric hypoxia conditions, concerning changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women.
- Prevent injuries in physical education and sports, by designing a useful training program for osteoporosis prevention as well as for managing carbohydrate and lipid metabolism disorders in premenopausal women.
- Conditions
- Hypoxia
- Being tested
- exercise and environmental conditions
- Keywords
- bone turnover, carbohydrate metabolism, lipid metabolism, normobaric hypoxia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and environmental conditionsOther
Participants will perform endurance-strength training for 4 weeks in a variety of environmental conditions. Somatic indices and quantitative indicators of bone mass (bone mineral density) will be measured both before and after the training period. Before the first training day and the day after the last training day, blood will be drawn for biochemical analysis.
exercise and environmental conditionsOther
Passive exposure to normobaric hypoxia conditions. No training intervention. There will be a measurement of selected somatic indices and a quantitative measurement of bone mass indices (bone mineral density). A blood draw for biochemical analysis will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will not undergo the training program. |
| Training in normobaric hypoxia | Experimental | Training performed under normobaric hypoxia (Week I-1600m above sea level; Week II-1800m above sea level; Week III-2200m above sea level; Week IV-2600m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%). Receives: Other: exercise and environmental conditions |
| Training in normoxia | Experimental | Description: Training performed in normoxia (223 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%). Receives: Other: exercise and environmental conditions |
| Passive exposure to normobaric hypoxia | Experimental | Passive exposure to normobaric hypoxia conditions (Week I -1600m above sea level; Week II -1800m above sea level; Week III -2200m above sea level; Week IV-2600m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%). Receives: Other: exercise and environmental conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood analysis- part 1
Bone turnover markers: bone-specific alkaline phosphatase (ng/ml), osteocalcin (ng/ml), N-terminal telopeptide of type I collagen (ng/ml), osteoprotegerin (ng/ml), 25-hydroxyvitamin D3 metabolite (ng/ml).
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 2
Hormones of lipid metabolism: adiponectin (μg/mL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 3
Hormones of lipid metabolism: lipid profile (mg/dL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 4
Hormones of lipid metabolism: lipoprotein atherogenicity index (no unit)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 5
Hormones of carbohydrate metabolism: glucose (mg/dL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 6
Hormones of carbohydrate metabolism: insulin (IU/mL), leptin (IU/mL), ghrelin (IU/mL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 7
Thyroid hormones: Thyroid Stimulating Hormone (IU/L)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 8
Vitamins: Vitamin D (ng/mL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 9
Plasma volume changes (ml/kg)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 10
Rheology: viscosity (Pa·s), viscoelasticity (Pa·s)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 11
Rheology: shear rate (s-¹)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 12
Rheology: shear stress (Pa), elastic modulus (Pa)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 13
Blood biochemistry: erythrocytes (million/μL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 14
Blood biochemistry: leukocytes (thousand/μL), platelets (thousand/μL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 15
Blood biochemistry: hemoglobin (g/dL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 16
Blood biochemistry: hematocrit (%), red cell distribution width (%)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 17
Blood biochemistry: mean corpuscular volume (femtoliter)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 18
Blood biochemistry: mean corpuscular hemoglobin (picogram)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 19
Blood biochemistry: mean corpuscular hemoglobin concentration (g/dL), albumin (g/dL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 20
Blood biochemistry: creatinine (mg/dL), bilirubin (mg/dL), blood urea nitrogen (mg/dL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 21
Blood biochemistry: erythrocyte sedimentation rate (mm/h)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 22
Blood biochemistry: alanine aminotransferase (U/L), aspartate aminotransferase (U/L)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood analysis- part 23
Blood biochemistry: ferritin (ng/mL)
Measured: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Bone mass- part 1
To identify quantitative indicators of bone mass, a densitometric study will be performed using dual energy X-ray absorptiometry (DXA). Selected quantitative indicators of bone mass will be measured: bone mineral density (g/cm^2).
Measured: 1 day before and 1 day after the training program. Training will last 4 weeks.
Bone mass- part 2
To identify quantitative indicators of bone mass, a densitometric study will be performed using dual energy X-ray absorptiometry (DXA). Selected quantitative indicators of bone mass will be measured: T-score (no unit).
Measured: 1 day before and 1 day after the training program. Training will last 4 weeks.
Bone mass- part 3
To identify quantitative indicators of bone mass, a densitometric study will be performed using dual energy X-ray absorptiometry (DXA). Selected quantitative indicators of bone mass will be measured: Z-score (no unit).
Measured: 1 day before and 1 day after the training program. Training will last 4 weeks.
Bone mass- part 4
To identify quantitative indicators of bone mass, a densitometric study will be performed using dual energy X-ray absorptiometry (DXA). Selected quantitative indicators of bone mass will be measured: relative skeletal-muscular index (kg/m^2).
Measured: 1 day before and 1 day after the training program. Training will last 4 weeks.
Somatic indicators- part 1
A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: lean body mass (kg).
Measured: 1 day before and 1 day after the training program. Training will last 4 weeks.
Somatic indicators- part 2
A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: percentage of body fat (%).
Measured: 1 day before and 1 day after the training program. Training will last 4 weeks.
Somatic indicators- part 3
A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: fat mass (kg).
Measured: 1 day before and 1 day after the training program. Training will last 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start7 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education and Science,Poland
- Responsible party
- Sponsor
- Investigators
- Małgorzata Bagińska, MSc, Principal investigator, Student of Doctoral studies, University of Physical Education in Kraków, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226168
- Sponsor's protocol ID
- NdS-II/SP/0512/2023/01
- Status last verified
- May 2024
- First submitted
- 11 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Author's Training Program in Normobaric Hypoxia on Changes in Bone Turnover Markers and Carbohydrate and Lipid Metabolism in Premenopausal Women
- ClinicalTrials.gov ID
- NCT06226168
- Acronym / sponsor ID
- NdS-II/SP/0512/2023/01
- Conditions
- Hypoxia
- Keywords
- bone turnover, carbohydrate metabolism, lipid metabolism, normobaric hypoxia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Collaborators
- Ministry of Education and Science,Poland
- Study start
- 7 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jan 2024 (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 impact of a proprietary training program in normobaric hypoxia on changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women falls within the realm of physical culture for an active and healthy society. Within this context, the implementation of a project is supported aiming to:
- Monitor, support, and promote physical development, fitness, and physical activity in society, by assessing the effects of a proprietary training program in normobaric hypoxia on changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women.
- Develop and implement innovative methods, forms, and means of physical activation and training for individuals of various ages, by formulating general assumptions of an endurance-strength training concept under normobaric hypoxia conditions, concerning changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women.
- Prevent injuries in physical education and sports, by designing a useful training program for osteoporosis prevention as well as for managing carbohydrate and lipid metabolism disorders in premenopausal women.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will not undergo the training program. |
| Training in normobaric hypoxia | Experimental | Other: exercise and environmental conditionsTraining performed under normobaric hypoxia (Week I-1600m above sea level; Week II-1800m above sea level; Week III-2200m above sea level; Week IV-2600m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%). |
| Training in normoxia | Experimental | Other: exercise and environmental conditionsDescription: Training performed in normoxia (223 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%). |
| Passive exposure to normobaric hypoxia | Experimental | Other: exercise and environmental conditionsPassive exposure to normobaric hypoxia conditions (Week I -1600m above sea level; Week II -1800m above sea level; Week III -2200m above sea level; Week IV-2600m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%). |
Who may qualify
- Ages
- 50 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No significant cardiovascular, respiratory system diseases and musculoskeletal system,
- No contraindications to physical activity. ECG, baseline urinalysis, morphology are required.
- T-score within normal limits (+1.0 to -1.0).
- Informed consent of the patient to participate in the study.
Key exclusion criteria (4 listed)
- Use of hormone replacement therapy (HRT).
- Use of substances (cigarettes, alcohol).
- Any training (including hypoxia training or exposure) performed in the 6 months prior to the beginning of the intervention
- Any other factors determined by the study investigators as unsuitable for participation.
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 |
|---|---|---|
| exercise and environmental conditionsParticipants will perform endurance-strength training for 4 weeks in a variety of environmental conditions. Somatic indices and quantitative indicators of bone mass (bone mineral density) will be measured both before and after the training period. Before the first training day and the day after the last training day, blood will be drawn for biochemical analysis. | Other | Training in normobaric hypoxia, Training in normoxia |
| exercise and environmental conditionsPassive exposure to normobaric hypoxia conditions. No training intervention. There will be a measurement of selected somatic indices and a quantitative measurement of bone mass indices (bone mineral density). A blood draw for biochemical analysis will be performed. | Other | Passive exposure to normobaric hypoxia |
Primary outcome
Blood analysis- part 1
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Bone turnover markers: bone-specific alkaline phosphatase (ng/ml), osteocalcin (ng/ml), N-terminal telopeptide of type I collagen (ng/ml), osteoprotegerin (ng/ml), 25-hydroxyvitamin D3 metabolite (ng/ml).
Blood analysis- part 2
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Hormones of lipid metabolism: adiponectin (μg/mL)
Blood analysis- part 3
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Hormones of lipid metabolism: lipid profile (mg/dL)
Blood analysis- part 4
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Hormones of lipid metabolism: lipoprotein atherogenicity index (no unit)
Blood analysis- part 5
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Hormones of carbohydrate metabolism: glucose (mg/dL)
Blood analysis- part 6
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Hormones of carbohydrate metabolism: insulin (IU/mL), leptin (IU/mL), ghrelin (IU/mL)
Blood analysis- part 7
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Thyroid hormones: Thyroid Stimulating Hormone (IU/L)
Blood analysis- part 8
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Vitamins: Vitamin D (ng/mL)
Blood analysis- part 9
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Plasma volume changes (ml/kg)
Blood analysis- part 10
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Rheology: viscosity (Pa·s), viscoelasticity (Pa·s)
Blood analysis- part 11
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Rheology: shear rate (s-¹)
Blood analysis- part 12
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Rheology: shear stress (Pa), elastic modulus (Pa)
Blood analysis- part 13
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: erythrocytes (million/μL)
Blood analysis- part 14
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: leukocytes (thousand/μL), platelets (thousand/μL)
Blood analysis- part 15
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: hemoglobin (g/dL)
Blood analysis- part 16
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: hematocrit (%), red cell distribution width (%)
Blood analysis- part 17
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: mean corpuscular volume (femtoliter)
Blood analysis- part 18
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: mean corpuscular hemoglobin (picogram)
Blood analysis- part 19
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: mean corpuscular hemoglobin concentration (g/dL), albumin (g/dL)
Blood analysis- part 20
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: creatinine (mg/dL), bilirubin (mg/dL), blood urea nitrogen (mg/dL)
Blood analysis- part 21
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: erythrocyte sedimentation rate (mm/h)
Blood analysis- part 22
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: alanine aminotransferase (U/L), aspartate aminotransferase (U/L)
Blood analysis- part 23
Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Blood biochemistry: ferritin (ng/mL)
Bone mass- part 1
Time frame: 1 day before and 1 day after the training program. Training will last 4 weeks.
To identify quantitative indicators of bone mass, a densitometric study will be performed using dual energy X-ray absorptiometry (DXA). Selected quantitative indicators of bone mass will be measured: bone mineral density (g/cm^2).
Bone mass- part 2
Time frame: 1 day before and 1 day after the training program. Training will last 4 weeks.
To identify quantitative indicators of bone mass, a densitometric study will be performed using dual energy X-ray absorptiometry (DXA). Selected quantitative indicators of bone mass will be measured: T-score (no unit).
Bone mass- part 3
Time frame: 1 day before and 1 day after the training program. Training will last 4 weeks.
To identify quantitative indicators of bone mass, a densitometric study will be performed using dual energy X-ray absorptiometry (DXA). Selected quantitative indicators of bone mass will be measured: Z-score (no unit).
Bone mass- part 4
Time frame: 1 day before and 1 day after the training program. Training will last 4 weeks.
To identify quantitative indicators of bone mass, a densitometric study will be performed using dual energy X-ray absorptiometry (DXA). Selected quantitative indicators of bone mass will be measured: relative skeletal-muscular index (kg/m^2).
Somatic indicators- part 1
Time frame: 1 day before and 1 day after the training program. Training will last 4 weeks.
A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: lean body mass (kg).
Somatic indicators- part 2
Time frame: 1 day before and 1 day after the training program. Training will last 4 weeks.
A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: percentage of body fat (%).
Somatic indicators- part 3
Time frame: 1 day before and 1 day after the training program. Training will last 4 weeks
A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: fat mass (kg).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Małgorzata Bagińska, MSc contact
Małgorzata Bagińska, MSc principal investigator
Student of Doctoral studies, University of Physical Education in Kraków, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and environmental conditions in people with Hypoxia, run by University School of Physical Education, Krakow, Poland at 2 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Radoń, MSc (+45126831142, anna.radon@awf.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood analysis- part 1 (time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts). The study lists 30 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 8 May 2024.