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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06226168
Enrollment
60
Registered
2024-01-26
Start date
2024-05-07
Completion date
2026-12-31
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia

Keywords

bone turnover, carbohydrate metabolism, lipid metabolism, normobaric hypoxia

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.

Interventions

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.

Sponsors

Ministry of Education and Science,Poland
CollaboratorUNKNOWN
University School of Physical Education, Krakow, Poland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 59 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood analysis- part 11Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsRheology: shear rate (s-¹)
Blood analysis- part 12Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsRheology: shear stress (Pa), elastic modulus (Pa)
Blood analysis- part 13Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: erythrocytes (million/μL)
Blood analysis- part 1Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBone 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 2Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsHormones of lipid metabolism: adiponectin (μg/mL)
Blood analysis- part 3Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsHormones of lipid metabolism: lipid profile (mg/dL)
Blood analysis- part 4Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsHormones of lipid metabolism: lipoprotein atherogenicity index (no unit)
Blood analysis- part 5Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsHormones of carbohydrate metabolism: glucose (mg/dL)
Blood analysis- part 6Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsHormones of carbohydrate metabolism: insulin (IU/mL), leptin (IU/mL), ghrelin (IU/mL)
Blood analysis- part 7Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsThyroid hormones: Thyroid Stimulating Hormone (IU/L)
Blood analysis- part 8Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsVitamins: Vitamin D (ng/mL)
Blood analysis- part 9Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsPlasma volume changes (ml/kg)
Blood analysis- part 10Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsRheology: viscosity (Pa·s), viscoelasticity (Pa·s)
Blood analysis- part 14Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: leukocytes (thousand/μL), platelets (thousand/μL)
Blood analysis- part 15Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: hemoglobin (g/dL)
Blood analysis- part 16Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: hematocrit (%), red cell distribution width (%)
Blood analysis- part 17Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: mean corpuscular volume (femtoliter)
Blood analysis- part 18Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: mean corpuscular hemoglobin (picogram)
Blood analysis- part 19Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: mean corpuscular hemoglobin concentration (g/dL), albumin (g/dL)
Blood analysis- part 20Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: creatinine (mg/dL), bilirubin (mg/dL), blood urea nitrogen (mg/dL)
Blood analysis- part 21Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: erythrocyte sedimentation rate (mm/h)
Blood analysis- part 22Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: alanine aminotransferase (U/L), aspartate aminotransferase (U/L)
Blood analysis- part 23Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workoutsBlood biochemistry: ferritin (ng/mL)
Bone mass- part 11 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 21 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 31 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 41 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 11 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 21 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 31 day before and 1 day after the training program. Training will last 4 weeksA densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: fat mass (kg).

Countries

Poland

Contacts

Primary ContactAnna Radoń, MSc
anna.radon@awf.krakow.pl+45126831142
Backup ContactMałgorzata Bagińska, MSc
malgorzata.baginska@doctoral.awf.krakow.pl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026