An interventional study of exercise and environmental conditions and exercise and environmental conditions in Hypoxia, sponsored by University School of Physical Education, Krakow, Poland. Recruiting at 2 sites in Poland. Open to female participants aged 50 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University School of Physical Education, Krakow, Poland · Not applicable, Interventional, and Diagnostic
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:
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →University School of Physical Education, Krakow, Poland is the lead sponsor of 20 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The control group will not undergo the training program.
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%).
Other: exercise and environmental conditions
Description: Training performed in normoxia (223 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%).
Other: exercise and environmental conditions
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%).
Other: exercise and environmental conditions
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.
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.
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).
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 analysis- part 2
Hormones of lipid metabolism: adiponectin (μg/mL)
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 analysis- part 3
Hormones of lipid metabolism: lipid profile (mg/dL)
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 analysis- part 4
Hormones of lipid metabolism: lipoprotein atherogenicity index (no unit)
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 analysis- part 5
Hormones of carbohydrate metabolism: glucose (mg/dL)
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 analysis- part 6
Hormones of carbohydrate metabolism: insulin (IU/mL), leptin (IU/mL), ghrelin (IU/mL)
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 analysis- part 7
Thyroid hormones: Thyroid Stimulating Hormone (IU/L)
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 analysis- part 8
Vitamins: Vitamin D (ng/mL)
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 analysis- part 9
Plasma volume changes (ml/kg)
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 analysis- part 10
Rheology: viscosity (Pa·s), viscoelasticity (Pa·s)
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 analysis- part 11
Rheology: shear rate (s-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
Blood analysis- part 12
Rheology: shear stress (Pa), elastic modulus (Pa)
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 analysis- part 13
Blood biochemistry: erythrocytes (million/μL)
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 analysis- part 14
Blood biochemistry: leukocytes (thousand/μL), platelets (thousand/μL)
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 analysis- part 15
Blood biochemistry: hemoglobin (g/dL)
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 analysis- part 16
Blood biochemistry: hematocrit (%), red cell distribution width (%)
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 analysis- part 17
Blood biochemistry: mean corpuscular volume (femtoliter)
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 analysis- part 18
Blood biochemistry: mean corpuscular hemoglobin (picogram)
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 analysis- part 19
Blood biochemistry: mean corpuscular hemoglobin concentration (g/dL), albumin (g/dL)
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 analysis- part 20
Blood biochemistry: creatinine (mg/dL), bilirubin (mg/dL), blood urea nitrogen (mg/dL)
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 analysis- part 21
Blood biochemistry: erythrocyte sedimentation rate (mm/h)
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 analysis- part 22
Blood biochemistry: alanine aminotransferase (U/L), aspartate aminotransferase (U/L)
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 analysis- part 23
Blood biochemistry: ferritin (ng/mL)
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 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: 1 day before and 1 day after the training program. Training will last 4 weeks
Plan to share: No
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University School of Physical Education, Krakow, Poland