Hypoxia, AltitudeNCT04089410

Direct and Cross Effects of Adaptation to Systemic Hyperthermia: Impact on Quality of Life, Neurohormonal and Psychophysiological Human Status

A study testing Hyperthermic Fitness Treatment (HFT), Physical Examination and Assessment of Cardiorespiratory Fitness in people with Hypoxia, Altitude and Exercise Tolerance, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypoxia, Altitude, Exercise Tolerance, Metabolic Disturbance
What is being tested?: Hyperthermic Fitness Treatment (HFT), Physical Examination and Assessment of Cardiorespiratory Fitness
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 1 siteRussia
Study dates: 14 Jan 2019to 27 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 30 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Russia1 site

Students health and quality of life laboratory
Moscow

Other trials in Russia

About this study

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.

Read the 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.

Conditions: Hypoxia, Altitude, Exercise Tolerance, Metabolic Disturbance, Quality of Life
Being tested: Hyperthermic Fitness Treatment (HFT), Placebo Hyperthermic Fitness Treatment, Physical Examination, Assessment of Cardiorespiratory Fitness, Autonomic Balance, Orthostatic and Hypoxic tolerance
Keywords: Adaptation, Systemic hyperthermia, Quality of life, Neuro-visceral interactions, Preventive medical technologies, Personalized approach, Neuroplasticity, Brain derived neurotrophic factor, Irisin, Heat Shock proteins
Medical subject headings: Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
Placebo Hyperthermic Fitness TreatmentDevice
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 ExaminationOther
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 FitnessOther
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 toleranceOther
1. Evaluation of Autonomic balance is assesed using Heart Rate Variability (HRV) analysis. The HRV test relies 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 are performed with a HR monitor.
2. Orthostatic tolerance is assessed after ANS balance assessment by HRV analysis to continue RR intervals registration for 3 min after participant was asked to stand up taking a vertical position near the couch.
3. The individual sensitivity to hypoxia is determined by conducting a 10-minute hypoxic test (HT) - breathing through a facial mask by a gas mixture with 11% of O2, with minute-by-minute monitoring of HR and hemoglobin saturation by oxygen (SaO2). Arterial blood pressure is recorded before and after HT.
Psychological TestingOther
1. Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36), which is a self-completed quantity of health-related QoL.
2. Participants are asked to complete the Pittsburgh Sleep Quality Index (PSQI), a retrospective self-report measure assessing their quality of sleep during the last three weeks preceding the study.
3. Anxiety level is estimated by using State and Trait Anxiety Scales (SA and TA) developed by Ch. Spielberger
4. Subjective Ratings of Thermosensation and Pain.Participants rate their comfort, thermosensation, and pain by fixing results in visual-analogous scale (VAS) while passing each of HFT treatment.
Measurement of Blood MarkersOther
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.

Study groups in NCT04089410
Study group	Role	What they receive
Hyperthermic Fitness Treatment	Active comparator	Participants will fill out study questionnaires. After basic body measurements subjects will undergo the HFT. Receives: Device: Hyperthermic Fitness Treatment (HFT); Other: Physical Examination; Other: Assessment of Cardiorespiratory Fitness; Other: Autonomic Balance, Orthostatic and Hypoxic tolerance; Other: Psychological Testing; Other: Measurement of Blood Markers
Attenuated heating	Placebo comparator	Participants will fill out study questionnaires. After basic body measurements subjects will undergo the placebo-HFT. Receives: Device: Placebo Hyperthermic Fitness Treatment; Other: Physical Examination; Other: Assessment of Cardiorespiratory Fitness; Other: Autonomic Balance, Orthostatic and Hypoxic tolerance; Other: Psychological Testing; Other: Measurement of Blood Markers

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: Week 13
Measurement of Blood Markers
Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
Measured: Week 1
Measurement of Blood Markers
Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
Measured: Week 5
Measurement of Blood Markers
Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
Measured: Week 13
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.
Measured: 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.
Measured: 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.
Measured: Week 13
Psychological stress tolerance: Sleep Quality
Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
Measured: Week 1
Psychological stress tolerance: Sleep Quality
Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
Measured: Week 5
Psychological stress tolerance: Sleep Quality
Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
Measured: Week 13
Psychological stress tolerance: Anxiety level
Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger)
Measured: Week 1
Psychological stress tolerance: Anxiety level
Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger)
Measured: Week 5
Psychological stress tolerance: Anxiety level
Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger)
Measured: Week 13

Secondary outcomes (7)

Hearth rate
Resting hearth rate (HR) values are measured twice in supine position.
Measured: Up to week 13
Blood pressure
Systolic and Diastolic blood pressure (SBP and DBP) values are measured twice in supine position.
Measured: 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).
Measured: Change between baseline and week 13
Metabolic rate
Metabolic rate at rest is measured in supine position by Fitmate MED gas analyzer (COSMED, Italy).
Measured: Change between baseline and week 13
Body mass
Body mass is measured in kilograms
Measured: Up to week 13
Height
Height is measured in meters
Measured: 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).
Measured: Change between baseline and week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 201927 Dec 2019

First posted13 Sep 2019
Study start14 Jan 2019
Primary completion9 Dec 2019
Study completion27 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (74)Papers the sponsor has linked to this study.
Other trials for Hypoxia, AltitudeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04089410
Sponsor's protocol ID: АААА-А19-119012190093-4
Status last verified: Nov 2020
First submitted: 6 Sep 2019
Last updated: 17 Nov 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 18052690
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.
PubMed 26073495
Aspelund A, Antila S, Proulx ST, Karlsen TV, Karaman S, Detmar M, Wiig H, Alitalo K. A dural lymphatic vascular system that drains brain interstitial fluid and macromolecules. J Exp Med. 2015 Jun 29;212(7):991-9. doi: 10.1084/jem.20142290. Epub 2015 Jun 15.
PubMed 26077718
Bath KG, Schilit A, Lee FS. Stress effects on BDNF expression: effects of age, sex, and form of stress. Neuroscience. 2013 Jun 3;239:149-56. doi: 10.1016/j.neuroscience.2013.01.074. Epub 2013 Feb 10.
PubMed 23402850
Bekinschtein P, Cammarota M, Katche C, Slipczuk L, Rossato JI, Goldin A, Izquierdo I, Medina JH. BDNF is essential to promote persistence of long-term memory storage. Proc Natl Acad Sci U S A. 2008 Feb 19;105(7):2711-6. doi: 10.1073/pnas.0711863105. Epub 2008 Feb 8.
PubMed 18263738
Bekinschtein P, Oomen CA, Saksida LM, Bussey TJ. Effects of environmental enrichment and voluntary exercise on neurogenesis, learning and memory, and pattern separation: BDNF as a critical variable? Semin Cell Dev Biol. 2011 Jul;22(5):536-42. doi: 10.1016/j.semcdb.2011.07.002. Epub 2011 Jul 7.
PubMed 21767656
Biro S, Masuda A, Kihara T, Tei C. Clinical implications of thermal therapy in lifestyle-related diseases. Exp Biol Med (Maywood). 2003 Nov;228(10):1245-9. doi: 10.1177/153537020322801023.
PubMed 14610268
Black EAE, Smith PM, McIsaac W, Ferguson AV. Brain-derived neurotrophic factor acts at neurons of the subfornical organ to influence cardiovascular function. Physiol Rep. 2018 May;6(10):e13704. doi: 10.14814/phy2.13704.
PubMed 29802680
Buchheit M, Papelier Y, Laursen PB, Ahmaidi S. Noninvasive assessment of cardiac parasympathetic function: postexercise heart rate recovery or heart rate variability? Am J Physiol Heart Circ Physiol. 2007 Jul;293(1):H8-10. doi: 10.1152/ajpheart.00335.2007. Epub 2007 Mar 23. No abstract available.
PubMed 17384128
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771
Cabanac M, Caputa M. Natural selective cooling of the human brain: evidence of its occurrence and magnitude. J Physiol. 1979 Jan;286:255-64. doi: 10.1113/jphysiol.1979.sp012617.
PubMed 439025
Cacioppo JT, Berntson GG, Binkley PF, Quigley KS, Uchino BN, Fieldstone A. Autonomic cardiac control. II. Noninvasive indices and basal response as revealed by autonomic blockades. Psychophysiology. 1994 Nov;31(6):586-98. doi: 10.1111/j.1469-8986.1994.tb02351.x.
PubMed 7846219
Carlino D, Francavilla R, Baj G, Kulak K, d'Adamo P, Ulivi S, Cappellani S, Gasparini P, Tongiorgi E. Brain-derived neurotrophic factor serum levels in genetically isolated populations: gender-specific association with anxiety disorder subtypes but not with anxiety levels or Val66Met polymorphism. PeerJ. 2015 Oct 29;3:e1252. doi: 10.7717/peerj.1252. eCollection 2015.
PubMed 26539329
Cotman CW, Berchtold NC, Christie LA. Exercise builds brain health: key roles of growth factor cascades and inflammation. Trends Neurosci. 2007 Sep;30(9):464-72. doi: 10.1016/j.tins.2007.06.011. Epub 2007 Aug 31.
PubMed 17765329
Edelmann E, Lessmann V, Brigadski T. Pre- and postsynaptic twists in BDNF secretion and action in synaptic plasticity. Neuropharmacology. 2014 Jan;76 Pt C:610-27. doi: 10.1016/j.neuropharm.2013.05.043. Epub 2013 Jun 18.
PubMed 23791959

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Direct and Cross Effects of Adaptation to Systemic Hyperthermia: Impact on Quality of Life, Neurohormonal and Psychophysiological Human Status
ClinicalTrials.gov ID: NCT04089410
Acronym / sponsor ID: АААА-А19-119012190093-4
Conditions: Hypoxia, Altitude, Exercise Tolerance, Metabolic Disturbance, Quality of Life
Keywords: Adaptation, Systemic hyperthermia, Quality of life, Neuro-visceral interactions, Preventive medical technologies, Personalized approach, Neuroplasticity, Brain derived neurotrophic factor
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
Study start: 14 Jan 2019 (actual)
Primary completion: 9 Dec 2019 (actual)
Study completion: 27 Dec 2019 (actual)
First posted: 13 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Hyperthermic Fitness Treatment	Active comparator	Device: Hyperthermic Fitness Treatment (HFT), Other: Physical Examination, Other: Assessment of Cardiorespiratory Fitness, Other: Autonomic Balance, Orthostatic and Hypoxic tolerance, Other: Psychological Testing, Other: Measurement of Blood MarkersParticipants will fill out study questionnaires. After basic body measurements subjects will undergo the HFT.
Attenuated heating	Placebo comparator	Device: Placebo Hyperthermic Fitness Treatment, Other: Physical Examination, Other: Assessment of Cardiorespiratory Fitness, Other: Autonomic Balance, Orthostatic and Hypoxic tolerance, Other: Psychological Testing, Other: Measurement of Blood MarkersParticipants will fill out study questionnaires. After basic body measurements subjects will undergo the placebo-HFT.

Who may qualify

Ages: 20 to 30 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hyperthermic Fitness Treatment (HFT)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.	Device	Hyperthermic Fitness Treatment
Placebo Hyperthermic Fitness TreatmentAttenuated 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.	Device	Attenuated heating
Physical ExaminationResting 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.	Other	Attenuated heating, Hyperthermic Fitness Treatment
Assessment of Cardiorespiratory FitnessAn 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.	Other	Attenuated heating, Hyperthermic Fitness Treatment
Autonomic Balance, Orthostatic and Hypoxic tolerance1. Evaluation of Autonomic balance is assesed using Heart Rate Variability (HRV) analysis. The HRV test relies 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 are performed with a HR monitor. 2. Orthostatic tolerance is assessed after ANS balance assessment by HRV analysis to continue RR intervals registration for 3 min after participant was asked to stand up taking a vertical position near the couch. 3. The individual sensitivity to hypoxia is determined by conducting a 10-minute hypoxic test (HT) - breathing through a facial mask by a gas mixture with 11% of O2, with minute-by-minute monitoring of HR and hemoglobin saturation by oxygen (SaO2). Arterial blood pressure is recorded before and after HT.	Other	Attenuated heating, Hyperthermic Fitness Treatment
Psychological Testing1. Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36), which is a self-completed quantity of health-related QoL. 2. Participants are asked to complete the Pittsburgh Sleep Quality Index (PSQI), a retrospective self-report measure assessing their quality of sleep during the last three weeks preceding the study. 3. Anxiety level is estimated by using State and Trait Anxiety Scales (SA and TA) developed by Ch. Spielberger 4. Subjective Ratings of Thermosensation and Pain.Participants rate their comfort, thermosensation, and pain by fixing results in visual-analogous scale (VAS) while passing each of HFT treatment.	Other	Attenuated heating, Hyperthermic Fitness Treatment
Measurement of Blood MarkersPeriferal 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.	Other	Attenuated heating, Hyperthermic Fitness Treatment

Primary outcome

Change in Cardiopulmonary Exercise Test
Time frame: 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
Time frame: 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).
Change in Cardiopulmonary Exercise Test
Time frame: 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
Time frame: Week 1
Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
Measurement of Blood Markers
Time frame: Week 5
Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
Measurement of Blood Markers
Time frame: Week 13
Serum BDNF, HGH, HSPs (60, 70, 90), Irisin concentrations
Psychological stress tolerance: Quality of Life
Time frame: 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
Time frame: 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: Quality of Life
Time frame: 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: Sleep Quality
Time frame: Week 1
Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
Psychological stress tolerance: Sleep Quality
Time frame: Week 5
Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
Psychological stress tolerance: Sleep Quality
Time frame: Week 13
Assessment of Sleep Quality(The Pittsburgh Sleep Quality Index)
Psychological stress tolerance: Anxiety level
Time frame: Week 1
Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger)
Psychological stress tolerance: Anxiety level
Time frame: Week 5
Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger)
Psychological stress tolerance: Anxiety level
Time frame: Week 13
Assessment of Anxiety level (State and Trait Anxiety Scales developed by Ch. Spielberger)

7 secondary outcomes

Hearth rate
Time frame: Up to week 13
Blood pressure
Time frame: Up to week 13
Body Mass Index
Time frame: Change between baseline and week 13
Metabolic rate
Time frame: Change between baseline and week 13
Body mass
Time frame: Up to week 13
Height
Time frame: 1 week
Autonomic Balance, Orthostatic and Hypoxic tolerance.
Time frame: Change between baseline and week 13

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
Background: PubMed 18052690Ansley 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.
Background: PubMed 26073495An 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.
Background: PubMed 26077718Aspelund A, Antila S, Proulx ST, Karlsen TV, Karaman S, Detmar M, Wiig H, Alitalo K. A dural lymphatic vascular system that drains brain interstitial fluid and macromolecules. J Exp Med. 2015 Jun 29;212(7):991-9. doi: 10.1084/jem.20142290. Epub 2015 Jun 15.
Background: PubMed 23402850Bath KG, Schilit A, Lee FS. Stress effects on BDNF expression: effects of age, sex, and form of stress. Neuroscience. 2013 Jun 3;239:149-56. doi: 10.1016/j.neuroscience.2013.01.074. Epub 2013 Feb 10.
Background: PubMed 18263738Bekinschtein P, Cammarota M, Katche C, Slipczuk L, Rossato JI, Goldin A, Izquierdo I, Medina JH. BDNF is essential to promote persistence of long-term memory storage. Proc Natl Acad Sci U S A. 2008 Feb 19;105(7):2711-6. doi: 10.1073/pnas.0711863105. Epub 2008 Feb 8.
Background: PubMed 21767656Bekinschtein P, Oomen CA, Saksida LM, Bussey TJ. Effects of environmental enrichment and voluntary exercise on neurogenesis, learning and memory, and pattern separation: BDNF as a critical variable? Semin Cell Dev Biol. 2011 Jul;22(5):536-42. doi: 10.1016/j.semcdb.2011.07.002. Epub 2011 Jul 7.
Background: PubMed 14610268Biro S, Masuda A, Kihara T, Tei C. Clinical implications of thermal therapy in lifestyle-related diseases. Exp Biol Med (Maywood). 2003 Nov;228(10):1245-9. doi: 10.1177/153537020322801023.
Background: PubMed 29802680Black EAE, Smith PM, McIsaac W, Ferguson AV. Brain-derived neurotrophic factor acts at neurons of the subfornical organ to influence cardiovascular function. Physiol Rep. 2018 May;6(10):e13704. doi: 10.14814/phy2.13704.
Background: PubMed 17384128Buchheit M, Papelier Y, Laursen PB, Ahmaidi S. Noninvasive assessment of cardiac parasympathetic function: postexercise heart rate recovery or heart rate variability? Am J Physiol Heart Circ Physiol. 2007 Jul;293(1):H8-10. doi: 10.1152/ajpheart.00335.2007. Epub 2007 Mar 23. No abstract available.
Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Background: PubMed 439025Cabanac M, Caputa M. Natural selective cooling of the human brain: evidence of its occurrence and magnitude. J Physiol. 1979 Jan;286:255-64. doi: 10.1113/jphysiol.1979.sp012617.
Background: PubMed 7846219Cacioppo JT, Berntson GG, Binkley PF, Quigley KS, Uchino BN, Fieldstone A. Autonomic cardiac control. II. Noninvasive indices and basal response as revealed by autonomic blockades. Psychophysiology. 1994 Nov;31(6):586-98. doi: 10.1111/j.1469-8986.1994.tb02351.x.
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- 9Link provided by the sponsor.
Brenner I.K. et al. The impact of heat exposure and repeated exercise on circulating stress hormones. European Journal of Applied Physiology and Occupational Physiology.1997; 76(5): 445-454Link provided by the sponsor.
Brisson G., Boisvert P., Peronnet F., Quirion A., Senecal L. Face cooling-induced reduction of plasma prolactin response to exercise as part of an integrated response to thermal stress. Eur J Appl Physiol Occup Physiol 1989; 58: 816-820Link provided by the sponsor.
Campbell B., Zito G., Colquhoun R., Martinez N., St Louis C. et al. Inter- and intra-day test-retest reliability of the Cosmed FitmateProTM indirect calorimeter for resting metabolic rate. Kathryn Raines University of South Florida, Tampa, Florida, USLink provided by the sponsor.
Halcox Julian P.J., Deanfield John, Shamaei-Tousi Alireza, Henderson Brian, Steptoe Andrew, Coates Anthony R.M., Singhal Atul and Lucas Alan. Circulating Human Heat Shock Protein 60 in the Blood of Healthy Teenagers: A Novel Determinant of EndothelialLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oleg Glazachev, MD study chair

Sechenov University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cardiopulmonary Exercise Test (time frame: Week 1). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04089410, which also lists 74 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.