Effect of the Author's Training Program in Normobaric Hypoxia on Changes in Bone Turnover Markers and Carbohydrate and Lipid Metabolism in Premenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood analysis- part 17
研究概览
简要总结
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:
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
The control group will not undergo the training program.
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%).
干预措施: exercise and environmental conditions (Other)
Training in normoxia
Description: Training performed in normoxia (223 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%).
干预措施: exercise and environmental conditions (Other)
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%).
干预措施: exercise and environmental conditions (Other)
结局指标
主要结局
Blood analysis- part 17
时间窗: 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 biochemistry: mean corpuscular volume (femtoliter)
Somatic indicators- part 1
时间窗: 1 day before and 1 day after the training program. Training will last 4 weeks.
A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: lean body mass (kg).
Blood analysis- part 7
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Thyroid hormones: Thyroid Stimulating Hormone (IU/L)
Blood analysis- part 16
时间窗: 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 biochemistry: hematocrit (%), red cell distribution width (%)
Blood analysis- part 22
时间窗: 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 biochemistry: alanine aminotransferase (U/L), aspartate aminotransferase (U/L)
Blood analysis- part 3
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Hormones of lipid metabolism: lipid profile (mg/dL)
Blood analysis- part 8
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Vitamins: Vitamin D (ng/mL)
Blood analysis- part 9
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Plasma volume changes (ml/kg)
Blood analysis- part 10
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Rheology: viscosity (Pa·s), viscoelasticity (Pa·s)
Blood analysis- part 2
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Hormones of lipid metabolism: adiponectin (μg/mL)
Blood analysis- part 4
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Hormones of lipid metabolism: lipoprotein atherogenicity index (no unit)
Blood analysis- part 20
时间窗: 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 biochemistry: creatinine (mg/dL), bilirubin (mg/dL), blood urea nitrogen (mg/dL)
Blood analysis- part 1
时间窗: 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 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).
Blood analysis- part 11
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Rheology: shear rate (s-¹)
Blood analysis- part 14
时间窗: 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 biochemistry: leukocytes (thousand/μL), platelets (thousand/μL)
Blood analysis- part 19
时间窗: 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 biochemistry: mean corpuscular hemoglobin concentration (g/dL), albumin (g/dL)
Bone mass- part 1
时间窗: 1 day before and 1 day after the training program. Training will last 4 weeks.
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).
Bone mass- part 3
时间窗: 1 day before and 1 day after the training program. Training will last 4 weeks.
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).
Blood analysis- part 5
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Hormones of carbohydrate metabolism: glucose (mg/dL)
Blood analysis- part 6
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Hormones of carbohydrate metabolism: insulin (IU/mL), leptin (IU/mL), ghrelin (IU/mL)
Blood analysis- part 12
时间窗: Before (10 minutes) and after (3 minutes) the first and last training.The training will last 4 weeks and will consist of 12 workouts
Rheology: shear stress (Pa), elastic modulus (Pa)
Blood analysis- part 13
时间窗: 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 biochemistry: erythrocytes (million/μL)
Blood analysis- part 18
时间窗: 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 biochemistry: mean corpuscular hemoglobin (picogram)
Blood analysis- part 21
时间窗: 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 biochemistry: erythrocyte sedimentation rate (mm/h)
Bone mass- part 2
时间窗: 1 day before and 1 day after the training program. Training will last 4 weeks.
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).
Bone mass- part 4
时间窗: 1 day before and 1 day after the training program. Training will last 4 weeks.
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).
Somatic indicators- part 3
时间窗: 1 day before and 1 day after the training program. Training will last 4 weeks
A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: fat mass (kg).
Blood analysis- part 15
时间窗: 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 biochemistry: hemoglobin (g/dL)
Blood analysis- part 23
时间窗: 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 biochemistry: ferritin (ng/mL)
Somatic indicators- part 2
时间窗: 1 day before and 1 day after the training program. Training will last 4 weeks.
A densitometry study using dual energy X-ray absorptiometry (DXA) will be conducted to determine body composition: percentage of body fat (%).
次要结局
未报告次要终点