Direct and Cross Effects of Adaptation to Systemic Hyperthermia: Impact on Quality of Life, Neurohormonal and Psychophysiological Human Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Psychological stress tolerance: Sleep Quality
研究概览
简要总结
Life expectancy and quality of human life are important indicator of the sustainable development of the society. At the same time, the physical, functional, emotional and psychological components of the of the quality of life evaluation are subjected to be evaluated objectively and corrected using modern medical and socio-psychological methods. According to a fair number of experts, the arsenal of means for functional rehabilitation and health promotion is limited, and its expansion is only possible on the basis of the principles of adaptation medicine and their translation from experimental research into specific preventive and health-promoting technologies.
The study is aimed at the development in molecular-endocrine, neuro-visceral and psychophysiological complex mechanisms of human long-term adaptation to systemic modern heating device-based hyperthermia for the development of medical technology focused on optimization in physical functioning, neuro-autonomic regulation, psycho-emotional status and stress- resistance as objective characteristics of humans' quality of life in working age.
The novelty of the project is the disclosure of key mechanisms of adaptational direct and cross-effects to the prolonged systemic individually dosed hyperthermia underlying the optimization of stress-resistance, psycho-physiological status and exercise tolerance of practically healthy persons and leading to an increase in the subjectively perceived quality of life.
The discovery of the mechanisms of hyperthermically induced neuroplasticity (in terms of the dynamics of oxidative stress, heat shock proteins and the brain derived neurotrophic factor) will also have a scientific significance, which in the long term prospectives may play a role in the development of technics for the prevention and rehabilitation of age-associated neuro-degenerative processes and diseases.
详细描述
Hyperthermic Fitness Treatment (HFT) is proved in many applied and clinical trials to be a helpful tool for enhancing thermal acclimation, physical tolerance and endurance, improving cardiovascular dysfunctions, normalizing metabolic status and body weight in patients with chronic non-infectious diseases and in aged healthy individuals. Clinical effects of hyperthermia acclimation or repeated sauna's sessions were investigated in series of well-designed placebo-controlled studies at different cohorts of Bronchial Asthma (BA), Chronic Obstructive Pulmonary Disease (COPD), Cardiovascular Disease (CVD) Metabolic Syndrome and Obesity (MS-O) patients, qualified professional sportsmen and healthy volunteers.
Effects of sauna bathing and hyperthermic treatments (acclimation to systemic, whole body dosed hyperthermia, which leads to core temperature increase on 2,0-2,5oC) are accurately described in well-controlled medical studies, performed by experienced researchers imposing different protocols (from 1 session lasting 15-20 min, daily 1 week up to 2 sessions per day, 3 weeks).
The generalized result of the most trials suggests adaptation to hyperthermia (sauna bathing sessions) is accompanied by a multi-faceted molecular, cellular, organic and systemic, organismic responses - by progressively increased resistance to thermal stressors, increased bronchial conductivity and pulmonary ventilation, sweating; stimulated activation of neuro-humoral and cardiovascular systems, boosted microcirculation and, as a consequence, providing more efficient transport and utilization of O2 by body tissues, resulting in increase of exercise tolerance, physical activity, normalization of appetite, balancing thermogenesis and heat release.
Mechanisms underlying the described clinical effects are partially connected with increased production of some neurotransmitters, hormones and peptides, among them - Brain derived neurotropic factor (BDNF), Somatotropin (Human Growth Hormone - HGH), Heat Shock Proteins family as cell signaling pathways inducers etc.
In spite of difference in study design, protocols, and hyperthermic mashines - devices, it is safe to make the conclusion that periodic individually adapted hyperthermic sessions are capable to induce haematological, neuro-humoral, cardiorespiratory and antioxidant adaptation to provide pathogenetic treatment and rehabilitation of patients with chronic non-infectious diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Outpatients, young healthy volunteers
- •Age > 19 years (20 - 30)
- •Gender: male
- •Healthy state (no chronic noninfectious diseases, documented by medical check-up results, obtained in 1-2 months before, not later), mobility (absence of orthopedic problems), satisfactory level of fitness
- •Ability to perform activities of daily living
- •Ability to attend all treatments and clinical-laboratory measurements
- •Signed informed consent form
排除标准
- •Infectious diseases
- •Increased body temperature before any step of the study
- •Individual hyperthermia (sauna) intolerance
- •Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the volunteer to participate in this study e.g. expected survival <1 year
- •Participation in another clinical study with an investigational product within 28 days prior to enrolment or previous randomization to an investigational product in another ongoing clinical study
研究组 & 干预措施
Hyperthermic Fitness Treatment
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the HFT.
干预措施: Hyperthermic Fitness Treatment (HFT) (Device)
Hyperthermic Fitness Treatment
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the HFT.
干预措施: Physical Examination (Other)
Hyperthermic Fitness Treatment
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the HFT.
干预措施: Assessment of Cardiorespiratory Fitness (Other)
Hyperthermic Fitness Treatment
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the HFT.
干预措施: Autonomic Balance, Orthostatic and Hypoxic tolerance (Other)
Hyperthermic Fitness Treatment
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the HFT.
干预措施: Psychological Testing (Other)
Hyperthermic Fitness Treatment
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the HFT.
干预措施: Measurement of Blood Markers (Other)
Attenuated heating
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the placebo-HFT.
干预措施: Placebo Hyperthermic Fitness Treatment (Device)
Attenuated heating
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the placebo-HFT.
干预措施: Physical Examination (Other)
Attenuated heating
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the placebo-HFT.
干预措施: Assessment of Cardiorespiratory Fitness (Other)
Attenuated heating
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the placebo-HFT.
干预措施: Autonomic Balance, Orthostatic and Hypoxic tolerance (Other)
Attenuated heating
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the placebo-HFT.
干预措施: Psychological Testing (Other)
Attenuated heating
Participants will fill out study questionnaires. After basic body measurements subjects will undergo the placebo-HFT.
干预措施: Measurement of Blood Markers (Other)
结局指标
主要结局
Psychological stress tolerance: Sleep Quality
时间窗: Week 13
Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
Change in Cardiopulmonary Exercise Test
时间窗: Week 13
An assessment of exercise tolerance and cardiorespiratory fitness (ET, CRF) is carried out by Cardiopulmonary Exercise Test - CPET) with the use of Fitmate MED gas analyzer (COSMED, Italy) and an Intertrack treadmill (Shiller, Switzerland).
Measurement of Blood Markers
时间窗: Week 13
Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
Psychological stress tolerance: Quality of Life
时间窗: Week 13
We assessed QoL using the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36), which is a self-completed quantity of health-related QoL. This questionnaire comprises eight domains covering physical functioning, vitality, role-physical, social functioning, bodily pain, role-emotional, general health and mental health. A high score indicates a better QoL characteristic. Furthermore, there are two summary scores which summarize two domains: first the Mental Component Summary and second the Physical Component Summary.
Psychological stress tolerance: Anxiety level
时间窗: Week 13
Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger)
Change in Cardiopulmonary Exercise Test
时间窗: Week 1
An assessment of exercise tolerance and cardiorespiratory fitness (ET, CRF) is carried out by Cardiopulmonary Exercise Test - CPET) with the use of Fitmate MED gas analyzer (COSMED, Italy) and an Intertrack treadmill (Shiller, Switzerland).
Change in Cardiopulmonary Exercise Test
时间窗: Week 5
An assessment of exercise tolerance and cardiorespiratory fitness (ET, CRF) is carried out by Cardiopulmonary Exercise Test - CPET) with the use of Fitmate MED gas analyzer (COSMED, Italy) and an Intertrack treadmill (Shiller, Switzerland).
Measurement of Blood Markers
时间窗: Week 1
Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
Measurement of Blood Markers
时间窗: Week 5
Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
Psychological stress tolerance: Quality of Life
时间窗: Week 1
We assessed QoL using the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36), which is a self-completed quantity of health-related QoL. This questionnaire comprises eight domains covering physical functioning, vitality, role-physical, social functioning, bodily pain, role-emotional, general health and mental health. A high score indicates a better QoL characteristic. Furthermore, there are two summary scores which summarize two domains: first the Mental Component Summary and second the Physical Component Summary.
Psychological stress tolerance: Quality of Life
时间窗: Week 5
We assessed QoL using the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36), which is a self-completed quantity of health-related QoL. This questionnaire comprises eight domains covering physical functioning, vitality, role-physical, social functioning, bodily pain, role-emotional, general health and mental health. A high score indicates a better QoL characteristic. Furthermore, there are two summary scores which summarize two domains: first the Mental Component Summary and second the Physical Component Summary.
Psychological stress tolerance: Sleep Quality
时间窗: Week 1
Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
Psychological stress tolerance: Sleep Quality
时间窗: Week 5
Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
Psychological stress tolerance: Anxiety level
时间窗: Week 1
Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger)
Psychological stress tolerance: Anxiety level
时间窗: Week 5
Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger)
次要结局
- Hearth rate(Up to week 13)
- Blood pressure(Up to week 13)
- Body Mass Index(Change between baseline and week 13)
- Metabolic rate(Change between baseline and week 13)
- Body mass(Up to week 13)
- Height(1 week)
- Autonomic Balance, Orthostatic and Hypoxic tolerance.(Change between baseline and week 13)
研究者
Dudnik Elena Nikolaevna
Associate professor
I.M. Sechenov First Moscow State Medical University