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Recruiting NCT06226168

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

No phase Interventional Hypoxia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: exercise and environmental conditions, exercise and environmental conditions.
Who it may be relevant to
Registry conditions: Hypoxia. Basic parameters: 50 years — 59 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

  • 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.

Primary outcome measures

  • Blood analysis- part 1 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Poland · 2 centers
  • University School of Physical Education in Cracow — Krakow
  • University School of Physical Education in Cracow — Krakow

Identifiers

NCT: NCT06226168 · NdS-II/SP/0512/2023/01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗