NCT04089410

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2019

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

September 6, 2019

Last Update Submit

November 16, 2020

Conditions

Keywords

AdaptationSystemic hyperthermiaQuality of lifeNeuro-visceral interactionsPreventive medical technologiesPersonalized approachNeuroplasticityBrain derived neurotrophic factorIrisinHeat Shock proteins

Outcome Measures

Primary Outcomes (15)

  • 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

    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

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Hyperthermic Fitness Treatment

ACTIVE COMPARATOR

Participants will fill out study questionnaires. After basic body measurements subjects will undergo the HFT.

Device: Hyperthermic Fitness Treatment (HFT)Other: Physical ExaminationOther: Assessment of Cardiorespiratory FitnessOther: Autonomic Balance, Orthostatic and Hypoxic toleranceOther: Psychological TestingOther: Measurement of Blood Markers

Attenuated heating

PLACEBO COMPARATOR

Participants will fill out study questionnaires. After basic body measurements subjects will undergo the placebo-HFT.

Device: Placebo Hyperthermic Fitness TreatmentOther: Physical ExaminationOther: Assessment of Cardiorespiratory FitnessOther: Autonomic Balance, Orthostatic and Hypoxic toleranceOther: Psychological TestingOther: Measurement of Blood Markers

Interventions

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.

Hyperthermic Fitness Treatment

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.

Attenuated heating

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.

Attenuated heatingHyperthermic Fitness Treatment

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.

Attenuated heatingHyperthermic Fitness Treatment

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.

Attenuated heatingHyperthermic Fitness Treatment

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.

Attenuated heatingHyperthermic Fitness Treatment

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 heatingHyperthermic Fitness Treatment

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Students health and quality of life laboratory

Moscow, Russia

Location

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Related Links

MeSH Terms

Conditions

Altitude Sickness

Interventions

Restraint, PhysicalStanding PositionPsychological Tests

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative TechniquesPostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaBehavioral Disciplines and Activities

Study Officials

  • Oleg Glazachev, MD

    Sechenov University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 13, 2019

Study Start

January 14, 2019

Primary Completion

December 9, 2019

Study Completion

December 27, 2019

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations