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

NCT ID: NCT06226168

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-07

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control group

The control group will not undergo the training program.

Group Type NO_INTERVENTION

No interventions assigned to this group

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%).

Group Type EXPERIMENTAL

exercise and environmental conditions

Intervention Type OTHER

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.

Training in normoxia

Description: Training performed in normoxia (223 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%).

Group Type EXPERIMENTAL

exercise and environmental conditions

Intervention Type OTHER

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

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%).

Group Type EXPERIMENTAL

exercise and environmental conditions

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Education and Science,Poland

UNKNOWN

Sponsor Role collaborator

University School of Physical Education, Krakow, Poland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Małgorzata Bagińska, MSc

Role: PRINCIPAL_INVESTIGATOR

Student of Doctoral studies, University of Physical Education in Kraków, Poland

Locations

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University School of Physical Education in Cracow

Krakow, , Poland

Site Status NOT_YET_RECRUITING

University School of Physical Education in Cracow

Krakow, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Anna Radoń, MSc

Role: CONTACT

+45126831142

Małgorzata Bagińska, MSc

Role: CONTACT

Facility Contacts

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Anna Radoń, MSc

Role: primary

+45126831142

Anna Radon, Msc

Role: primary

48 12 6831142

Other Identifiers

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NdS-II/SP/0512/2023/01

Identifier Type: -

Identifier Source: org_study_id

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