Clinical trial NCT06226168: Effects of Normobaric Hypoxia Exercise Program on Bone Turnover Markers and Metabolism in Premenopausal Women
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxia
Keywords: bone turnover
carbohydrate metabolism
lipid metabolism
normobaric hypoxia
Lead sponsor: University School of Physical Education, Krakow, Poland
Sponsor class: OTHER
Collaborators: name: Ministry of Education and Science,Poland
First posted: 2024-01-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Blood analysis- part 1
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 2
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 3
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 4
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 5
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 6
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 7
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 8
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 9
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 10
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 11
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 12
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 13
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 14
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 15
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 16
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 17
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 18
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 19
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 20
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 21
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 22
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Blood analysis- part 23
timeFrame: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
measure: Bone mass- part 1
timeFrame: 1 day before and 1 day after the training program. Training will last 4 weeks.
measure: Bone mass- part 2
timeFrame: 1 day before and 1 day after the training program. Training will last 4 weeks.
measure: Bone mass- part 3
timeFrame: 1 day before and 1 day after the training program. Training will last 4 weeks.
measure: Bone mass- part 4
timeFrame: 1 day before and 1 day after the training program. Training will last 4 weeks.
measure: Somatic indicators- part 1
timeFrame: 1 day before and 1 day after the training program. Training will last 4 weeks.
measure: Somatic indicators- part 2
timeFrame: 1 day before and 1 day after the training program. Training will last 4 weeks.
measure: Somatic indicators- part 3
timeFrame: 1 day before and 1 day after the training program. Training will last 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: University School of Physical Education in Cracow
city: Kraków
country: Poland
facility: University School of Physical Education in Cracow
Study officials:
affiliation: Student of Doctoral studies, University of Physical Education in Kraków, Poland
name: Małgorzata Bagińska, MSc
role: PRINCIPAL_INVESTIGATOR
References: