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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.
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.
Enhanced stress resistance and improved oxygen transfer/utilization are basic mechanisms whereby the organism increases its resistance to any physical and environmental stressors and to variety of pathogenic factors.
The described Hyperthermic Fitness Treatment (HFT) method is safe, has no significant complications or adverse side effects and is generally very well tolerated by sportsmen, healthy persons and different clinical patients' groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperthermic Fitness Treatment | Active Comparator | Participants will fill out study questionnaires. After basic body measurements subjects will undergo the HFT. |
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| Attenuated heating | Placebo Comparator | Participants will fill out study questionnaires. After basic body measurements subjects will undergo the placebo-HFT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperthermic Fitness Treatment (HFT) | Device | The Hyperthermic Fitness Treatment uses Alfa Basic capsule, an ergonomic camera in which a participant may take a lying position and undergo hyperthermia procedures (infrared heating with intracapsule temperature increase up to 80 degrees C◦), the head being outside the camera blown by cool air with a built-in ventilator. HFT is comparable to dry sauna bathing. Core body temperatures will be raised to 37.5-38.5°C◦. Recommended duration of one HFT session is 40 min. All the HFT group participants while undergoing sessions in the Cocoon will be dressed in bathing suits. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiopulmonary Exercise Test | 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). | Week 1 |
| Change in Cardiopulmonary Exercise Test | 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). | Week 5 |
| Change in Cardiopulmonary Exercise Test | 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). | Week 13 |
| Measurement of Blood Markers | Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations | Week 1 |
| Measurement of Blood Markers | Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations | Week 5 |
| Measurement of Blood Markers | Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations | Week 13 |
| Psychological stress tolerance: Quality of Life |
| Measure | Description | Time Frame |
|---|---|---|
| Hearth rate | Resting hearth rate (HR) values are measured twice in supine position. | Up to week 13 |
| Blood pressure | Systolic and Diastolic blood pressure (SBP and DBP) values are measured twice in supine position. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oleg Glazachev, MD | Sechenov University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Students health and quality of life laboratory | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18052690 | Background | Ansley L, Marvin G, Sharma A, Kendall MJ, Jones DA, Bridge MW. The effects of head cooling on endurance and neuroendocrine responses to exercise in warm conditions. Physiol Res. 2008;57(6):863-872. Epub 2007 Nov 30. | |
| 26073495 | Background | An JJ, Liao GY, Kinney CE, Sahibzada N, Xu B. Discrete BDNF Neurons in the Paraventricular Hypothalamus Control Feeding and Energy Expenditure. Cell Metab. 2015 Jul 7;22(1):175-88. doi: 10.1016/j.cmet.2015.05.008. Epub 2015 Jun 11. |
| Label | URL |
|---|---|
| Brigadski T., and Leßmann V. BDNF: a regulator of learning and memory processes with clinical potential. e-Neuroforum 2014; 5, 1-11. doi: 10.1007/s13295- 014- 0053- 9 | View source |
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| Placebo Hyperthermic Fitness Treatment | Device | Attenuated heating with less heat set (20-30 degrees C◦). This results in no increase of core body temperature. The participant will still feel heat and will see similar lighting and hear similar sounds as those occurring during actual HFT, and will be in the capsule for the same period of time. |
|
| Physical Examination | Other | Resting hearth rate (HR), Systolic and Diastolic blood pressure (SBP and DBP) values are measured twice in supine position using an automatic tonometer after 5 min of rest. Body mass (BM) and height are measured to calculate Body Mass Index. Body composition is assessed with the use of portable body-impedance-meter for the whole body impedance-analysis. Body core temperature, Blood pressure (BP) and Heart rate (HR) are measured before and right after each session. Arterial oxygen saturation (SpO2) and HR is monitored continuously by the use of a pulse oximeter, attached to the index fingertip of non dominant hand. |
|
| Assessment of Cardiorespiratory Fitness | Other | An assessment of exercise tolerance and cardiorespiratory fitness (ET, CRF) is carried out with the use of Cardiopulmonary Exercise Test - CPET). Testing is carried out using a gas analyzer and an Intertrack treadmill. Evaluation of gas exchange parameters conducted according to a given program - Cardiopulmonary load testing. |
|
| Autonomic Balance, Orthostatic and Hypoxic tolerance | Other |
|
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| Psychological Testing | Other |
|
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| Measurement of Blood Markers | Other | Periferal venous blood (10 ml) sumples of the fastest (overnight fast) study subjects are withdrawn by a qualified laboratory technician via aseptic technique from the antecubital vein in the sitting position, using sterile needles and are collected. Serum BDNF, HGH, HSPs (60, 70, 90) concentrations are determined. |
|
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.
| Week 1 |
| Psychological stress tolerance: Quality of Life | 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. | Week 5 |
| Psychological stress tolerance: Quality of Life | 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. | Week 13 |
| Psychological stress tolerance: Sleep Quality | Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index) | Week 1 |
| Psychological stress tolerance: Sleep Quality | Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index) | Week 5 |
| Psychological stress tolerance: Sleep Quality | Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index) | Week 13 |
| Psychological stress tolerance: Anxiety level | Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger) | Week 1 |
| Psychological stress tolerance: Anxiety level | Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger) | Week 5 |
| Psychological stress tolerance: Anxiety level | Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger) | Week 13 |
| Up to week 13 |
| Body Mass Index | Body mass (BM) in kilograms and height in meters are measured (Seca 888 scale, Hamburg, Germany) to calculate Body Mass Index (BMI, in kg/m2). Metabolic rate at rest is measured in supine position by Fitmate MED gas analyzer (COSMED, Italy). | Change between baseline and week 13 |
| Metabolic rate | Metabolic rate at rest is measured in supine position by Fitmate MED gas analyzer (COSMED, Italy). | Change between baseline and week 13 |
| Body mass | Body mass is measured in kilograms | Up to week 13 |
| Height | Height is measured in meters | 1 week |
| Autonomic Balance, Orthostatic and Hypoxic tolerance. | For the assessment of participants' autonomic regulation Heart Rate Variability (HRV) analysis is selected.Briefly, the HRV test relied on a 5-min RR interval (time in milliseconds between two R waves of the electrocardiogram complex) recorded at rest for 5 min supine (SU) followed of 5 min resting time. Measurement of the interval duration between two R waves of the cardiac electrical activity is performed with a HR monitor (VNS-Spectrum hardware and software complex (Neurosoft Company, Ivanovo, Russia). | Change between baseline and week 13 |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D000078783 | Standing Position |
| D011581 | Psychological Tests |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided