- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089410
Direct and Cross Effects of Adaptation to Systemic Hyperthermia: Impact on Quality of Life, Neurohormonal and Psychophysiological Human Status
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Moscow, Russian Federation
- Students health and quality of life laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Hyperthermic Fitness Treatment
Participants will fill out study questionnaires.
After basic body measurements subjects will undergo the HFT.
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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.
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.
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.
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.
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PLACEBO_COMPARATOR: Attenuated heating
Participants will fill out study questionnaires.
After basic body measurements subjects will undergo the placebo-HFT.
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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.
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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cardiopulmonary Exercise Test
Time Frame: Week 1
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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).
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Week 1
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Change in Cardiopulmonary Exercise Test
Time Frame: Week 5
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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).
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Week 5
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Change in Cardiopulmonary Exercise Test
Time Frame: Week 13
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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).
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Week 13
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Measurement of Blood Markers
Time Frame: Week 1
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Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
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Week 1
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Measurement of Blood Markers
Time Frame: Week 5
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Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
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Week 5
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Measurement of Blood Markers
Time Frame: Week 13
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Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
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Week 13
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Psychological stress tolerance: Quality of Life
Time Frame: Week 1
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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.
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Week 1
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Psychological stress tolerance: Quality of Life
Time Frame: Week 5
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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.
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Week 5
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Psychological stress tolerance: Quality of Life
Time Frame: Week 13
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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.
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Week 13
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Psychological stress tolerance: Sleep Quality
Time Frame: Week 1
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Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
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Week 1
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Psychological stress tolerance: Sleep Quality
Time Frame: Week 5
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Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
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Week 5
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Psychological stress tolerance: Sleep Quality
Time Frame: Week 13
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Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
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Week 13
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Psychological stress tolerance: Anxiety level
Time Frame: Week 1
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Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch.
Spielberger)
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Week 1
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Psychological stress tolerance: Anxiety level
Time Frame: Week 5
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Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch.
Spielberger)
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Week 5
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Psychological stress tolerance: Anxiety level
Time Frame: Week 13
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Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch.
Spielberger)
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Week 13
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hearth rate
Time Frame: Up to week 13
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Resting hearth rate (HR) values are measured twice in supine position.
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Up to week 13
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Blood pressure
Time Frame: Up to week 13
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Systolic and Diastolic blood pressure (SBP and DBP) values are measured twice in supine position.
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Up to week 13
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Body Mass Index
Time Frame: Change between baseline and week 13
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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).
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Change between baseline and week 13
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Metabolic rate
Time Frame: Change between baseline and week 13
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Metabolic rate at rest is measured in supine position by Fitmate MED gas analyzer (COSMED, Italy).
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Change between baseline and week 13
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Body mass
Time Frame: Up to week 13
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Body mass is measured in kilograms
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Up to week 13
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Height
Time Frame: 1 week
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Height is measured in meters
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1 week
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Autonomic Balance, Orthostatic and Hypoxic tolerance.
Time Frame: Change between baseline and week 13
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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).
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Change between baseline and week 13
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Collaborators and Investigators
Investigators
- Study Chair: Oleg Glazachev, MD, Sechenov University
Publications and helpful links
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Helpful Links
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First Submitted That Met QC Criteria
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- АААА-А19-119012190093-4
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