Effects of Normobaric Hypoxia Exercise Program on Bone Turnover Markers and Metabolism in Premenopausal Women
- Conditions
- Hypoxia
- Interventions
- Other: exercise and environmental conditions
- Registration Number
- NCT06226168
- Lead Sponsor
- University School of Physical Education, Krakow, Poland
- Brief 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. Within this context, the implementation of a project is supported aiming to:
1. 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.
2. 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.
3. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Training in normobaric hypoxia exercise and environmental conditions 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%). Training in normoxia exercise and environmental conditions Description: Training performed in normoxia (223 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%). Passive exposure to normobaric hypoxia 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%).
- Primary Outcome Measures
Name Time Method Somatic indicators- part 1 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).
Blood analysis- part 7 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 16 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 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 22 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 3 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 8 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 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 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 2 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 4 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 20 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 1 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 11 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 14 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 19 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)
Bone mass- part 1 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 3 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).
Blood analysis- part 5 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 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 12 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 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 18 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 21 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)
Bone mass- part 2 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 4 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 3 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).
Blood analysis- part 15 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 23 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)
Somatic indicators- part 2 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 (%).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University School of Physical Education in Cracow
🇵🇱Kraków, Poland