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

U

University School of Physical Education, Krakow, Poland

Status

Enrolling

Conditions

Hypoxia

Treatments

Other: exercise and environmental conditions

Study type

Interventional

Funder types

Other

Identifiers

NCT06226168
NdS-II/SP/0512/2023/01

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

50 to 59 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 4 patient groups

Control group
No Intervention group
Description:
The control group will not undergo the training program.
Training in normobaric hypoxia
Experimental group
Description:
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%).
Treatment:
Other: exercise and environmental conditions
Training in normoxia
Experimental group
Description:
Description: Training performed in normoxia (223 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%).
Treatment:
Other: exercise and environmental conditions
Passive exposure to normobaric hypoxia
Experimental group
Description:
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%).
Treatment:
Other: exercise and environmental conditions

Trial contacts and locations

2

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Central trial contact

Anna Radoń, MSc; Małgorzata Bagińska, MSc

Data sourced from clinicaltrials.gov

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