Effects of Normobaric Hypoxia Exercise Program on Bone Turnover Markers and Metabolism in Premenopausal Women

Hypoxia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226168
• Other study ID #: NdS-II/SP/0512/2023/01
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University School of Physical Education, Krakow, Poland
• Contact: Anna Radon, MSc
• Phone: +45126831142
• Email: anna.radon[@]awf.krakow.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 59 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hypoxia

Intervention

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.
• exercise and environmental conditions
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.

Locations

Country	Name	City	State
Poland	University School of Physical Education in Cracow	Krakow
Poland	University School of Physical Education in Cracow	Kraków

Sponsors (2)

Lead Sponsor	Collaborator
University School of Physical Education, Krakow, Poland	Ministry of Education and Science,Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 2	Hormones of lipid metabolism: adiponectin (µg/mL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 3	Hormones of lipid metabolism: lipid profile (mg/dL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 4	Hormones of lipid metabolism: lipoprotein atherogenicity index (no unit)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 5	Hormones of carbohydrate metabolism: glucose (mg/dL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 6	Hormones of carbohydrate metabolism: insulin (IU/mL), leptin (IU/mL), ghrelin (IU/mL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 7	Thyroid hormones: Thyroid Stimulating Hormone (IU/L)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 8	Vitamins: Vitamin D (ng/mL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 9	Plasma volume changes (ml/kg)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 10	Rheology: viscosity (Pa·s), viscoelasticity (Pa·s)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 11	Rheology: shear rate (s-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
Primary	Blood analysis- part 12	Rheology: shear stress (Pa), elastic modulus (Pa)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 13	Blood biochemistry: erythrocytes (million/µL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 14	Blood biochemistry: leukocytes (thousand/µL), platelets (thousand/µL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 15	Blood biochemistry: hemoglobin (g/dL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 16	Blood biochemistry: hematocrit (%), red cell distribution width (%)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 17	Blood biochemistry: mean corpuscular volume (femtoliter)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 18	Blood biochemistry: mean corpuscular hemoglobin (picogram)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 19	Blood biochemistry: mean corpuscular hemoglobin concentration (g/dL), albumin (g/dL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 20	Blood biochemistry: creatinine (mg/dL), bilirubin (mg/dL), blood urea nitrogen (mg/dL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 21	Blood biochemistry: erythrocyte sedimentation rate (mm/h)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 22	Blood biochemistry: alanine aminotransferase (U/L), aspartate aminotransferase (U/L)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	Blood analysis- part 23	Blood biochemistry: ferritin (ng/mL)	Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Primary	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).	1 day before and 1 day after the training program. Training will last 4 weeks.
Primary	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).	1 day before and 1 day after the training program. Training will last 4 weeks.
Primary	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).	1 day before and 1 day after the training program. Training will last 4 weeks.
Primary	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).	1 day before and 1 day after the training program. Training will last 4 weeks.
Primary	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).	1 day before and 1 day after the training program. Training will last 4 weeks.
Primary	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 (%).	1 day before and 1 day after the training program. Training will last 4 weeks.
Primary	Somatic indicators- part 3	A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: fat mass (kg).	1 day before and 1 day after the training program. Training will last 4 weeks