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

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia
• Intervention / Treatment: Other: exercise and environmental conditions; Other: exercise and environmental conditions

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Radoń, MSc; Phone Number: +45126831142; Email: anna.radon@awf.krakow.pl
• Study Contact Backup: Name: Małgorzata Bagińska, MSc; Email: malgorzata.baginska@doctoral.awf.krakow.pl

Study Locations

• Poland
  • Krakow, Poland, 31-571
    • Recruiting
    • University School of Physical Education in Cracow
    • Contact: Anna Radon, Msc; Phone Number: 48 12 6831142; Email: anna.radon@awf.krakow.pl
  • Kraków, Poland, 31-571
    • Not yet recruiting
    • University School of Physical Education in Cracow
    • Contact: Anna Radoń, MSc; Phone Number: +45126831142; Email: anna.radon@awf.krakow.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group will not undergo the training program.
Experimental: Training in normobaric hypoxia; 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; 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.; Other: 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.
Experimental: Training in normoxia; Description: Training performed in normoxia (223 m 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.; Other: 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.
Experimental: Passive exposure to normobaric hypoxia; 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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

Collaborators and Investigators

• Sponsor: University School of Physical Education, Krakow, Poland
• Collaborators: Ministry of Education and Science,Poland
• Investigators: Principal Investigator: Małgorzata Bagińska, MSc, Student of Doctoral studies, University of Physical Education in Kraków, Poland

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: lipid metabolism; carbohydrate metabolism; bone turnover; normobaric hypoxia
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: NdS-II/SP/0512/2023/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No