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

NACompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

January 14, 2019

Primary Completion Date

December 9, 2019

Study Completion Date

December 27, 2019

Conditions
Hypoxia, AltitudeExercise ToleranceMetabolic DisturbanceQuality of Life
Interventions
DEVICE

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

Placebo 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.

OTHER

Physical Examination

"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."

OTHER

Assessment of Cardiorespiratory Fitness

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.

OTHER

Autonomic Balance, Orthostatic and Hypoxic tolerance

"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."

OTHER

Psychological Testing

"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."

OTHER

Measurement of Blood Markers

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.

Trial Locations (1)

Unknown

Students health and quality of life laboratory, Moscow

All Listed Sponsors
lead

I.M. Sechenov First Moscow State Medical University

OTHER

NCT04089410 - Direct and Cross Effects of Adaptation to Systemic Hyperthermia: Impact on Quality of Life, Neurohormonal and Psychophysiological Human Status | Biotech Hunter | Biotech Hunter