NCT04089410

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

Completed NA Last updated 17 November 2020

What this trial tests

NA trial testing Hyperthermic Fitness Treatment (HFT) in Hypoxia, Altitude in 67 participants. Completed in 27 December 2019.

Timeline

14 January 2019

Primary endpoint
9 December 2019

27 December 2019

Quick facts

Lead sponsor	I.M. Sechenov First Moscow State Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	67
Start date	14 January 2019
Primary completion	9 December 2019
Estimated completion	27 December 2019
Sites	1 location across Russia

Drugs / interventions tested

• Hyperthermic Fitness Treatment (HFT)
• Placebo Hyperthermic Fitness Treatment
• Physical Examination
• Assessment of Cardiorespiratory Fitness
• Autonomic Balance, Orthostatic and Hypoxic tolerance
• Psychological Testing
• Measurement of Blood Markers

Conditions studied

• Hypoxia, Altitude — all drugs for Hypoxia, Altitude →
• Exercise Tolerance — all drugs for Exercise Tolerance →
• Metabolic Disturbance — all drugs for Metabolic Disturbance →
• Quality of Life — all drugs for Quality of Life →

Sponsor

I.M. Sechenov First Moscow State Medical University

Who can join

Adults 20 to 30, male only, with Hypoxia, Altitude or Exercise Tolerance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.