NCT06226168

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. 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. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
May 2024Dec 2026

First Submitted

Initial submission to the registry

December 11, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 7, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

2.6 years

First QC Date

December 11, 2023

Last Update Submit

May 7, 2024

Conditions

Hypoxia

Keywords

bone turnovercarbohydrate metabolismlipid metabolismnormobaric hypoxia

Outcome Measures

Primary Outcomes (30)

  • Blood analysis- part 1

    Bone 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).

    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

    Hormones of lipid metabolism: adiponectin (μg/mL)

    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

    Hormones of lipid metabolism: lipid profile (mg/dL)

    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

    Hormones of lipid metabolism: lipoprotein atherogenicity index (no unit)

    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

    Hormones of carbohydrate metabolism: glucose (mg/dL)

    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

    Hormones of carbohydrate metabolism: insulin (IU/mL), leptin (IU/mL), ghrelin (IU/mL)

    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

    Thyroid hormones: Thyroid Stimulating Hormone (IU/L)

    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

    Vitamins: Vitamin D (ng/mL)

    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

    Plasma volume changes (ml/kg)

    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

    Rheology: viscosity (Pa·s), viscoelasticity (Pa·s)

    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 11

    Rheology: shear rate (s-¹)

    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 12

    Rheology: shear stress (Pa), elastic modulus (Pa)

    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 13

    Blood biochemistry: erythrocytes (million/μL)

    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 14

    Blood biochemistry: leukocytes (thousand/μL), platelets (thousand/μL)

    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 15

    Blood biochemistry: hemoglobin (g/dL)

    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 16

    Blood biochemistry: hematocrit (%), red cell distribution width (%)

    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 17

    Blood biochemistry: mean corpuscular volume (femtoliter)

    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 18

    Blood biochemistry: mean corpuscular hemoglobin (picogram)

    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 19

    Blood biochemistry: mean corpuscular hemoglobin concentration (g/dL), albumin (g/dL)

    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 20

    Blood biochemistry: creatinine (mg/dL), bilirubin (mg/dL), blood urea nitrogen (mg/dL)

    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 21

    Blood biochemistry: erythrocyte sedimentation rate (mm/h)

    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 22

    Blood biochemistry: alanine aminotransferase (U/L), aspartate aminotransferase (U/L)

    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 23

    Blood biochemistry: ferritin (ng/mL)

    Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts

  • Bone mass- part 1

    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).

    1 day before and 1 day after the training program. Training will last 4 weeks.

  • Bone mass- part 2

    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).

    1 day before and 1 day after the training program. Training will last 4 weeks.

  • Bone mass- part 3

    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).

    1 day before and 1 day after the training program. Training will last 4 weeks.

  • Bone mass- part 4

    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).

    1 day before and 1 day after the training program. Training will last 4 weeks.

  • Somatic indicators- part 1

    A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: lean body mass (kg).

    1 day before and 1 day after the training program. Training will last 4 weeks.

  • Somatic indicators- part 2

    A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: percentage of body fat (%).

    1 day before and 1 day after the training program. Training will last 4 weeks.

  • Somatic indicators- part 3

    A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: fat mass (kg).

    1 day before and 1 day after the training program. Training will last 4 weeks

Study Arms (4)

Control group

NO INTERVENTION

The control group will not undergo the training program.

Training in normobaric hypoxia

EXPERIMENTAL

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%).

Other: exercise and environmental conditions

Training in normoxia

EXPERIMENTAL

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

Other: exercise and environmental conditions

Passive exposure to normobaric hypoxia

EXPERIMENTAL

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%).

Other: exercise and environmental conditions

Interventions

exercise and environmental conditionsOTHER

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 normobaric hypoxiaTraining in normoxia

Eligibility Criteria

Age50 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University School of Physical Education in Cracow

Krakow, 31-571, Poland

NOT YET RECRUITING

University School of Physical Education in Cracow

Krakow, 31-571, Poland

RECRUITING

MeSH Terms

Conditions

Hypoxia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Małgorzata Bagińska, MSc

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Radoń, MSc

CONTACT

+45126831142anna.radon@awf.krakow.pl

Małgorzata Bagińska, MSc

CONTACT

malgorzata.baginska@doctoral.awf.krakow.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2023

First Posted

January 26, 2024

Study Start

May 7, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

PL(2)