Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06575985

Mechanisms Underlying Hypoxic, Heat and Cross-tolerance Adaptation in Women

Investigating the Effects of a 10-day Heat Acclimation and Exercise Intervention on Physiological Adaptations and Cross-tolerance in Women

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Jozef Stefan Institute · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Accepted

Summary

This study will consist of a parallel-groups design, with 30 healthy active female participants randomly assigned to either an experimental heat acclimation and exercise intervention, or a thermo-neutral exercise intervention control group. Interventions will be 10 days in duration, and consist of daily 60-minute exercise bouts under the appropriate environmental condition. Before and after each intervention, various tests will be conducted to establish exercise capacity under various environmental conditions, as well as underlying mechanisms of physiological adaptation induced by each intervention.

Detailed description

Most research on how the human body responds to different environmental conditions has primarily focused on men, leaving a gap in our understanding of how women adapt to these conditions. Heat exposure in particular is known to affect the well-being and performance of humans, as well as induce chronic adaptations through an acclimation/acclimatization process, which helps the body to better regulate core temperature. Moreover, contemporary research is beginning to explore the 'cross-tolerance' phenomenon; the notion that exposure (and acclimation/acclimatization) to one environmental stressor may affect the responses to another. In particular, both heat and hypoxia are known to activate common acclimatization pathways, with pulmonary, cardiovascular, hematological and muscular adaptations occurring to facilitate both oxygen transport and core body temperature regulation. In line with this background, the primary aim of this study is to investigate the effects of a heat acclimation and exercise intervention, relative to a thermo-neutral exercise control intervention, on exercise tolerance under various environmental conditions (heat, hypoxia, neutral) in healthy, active women. The secondary aim is to establish mechanisms of adaptation, by exploring the intervention-induced changes in pulmonary, cardiovascular, hematological and muscular factors, through various tests conducted at rest and during exercise. To address these aims, 30 healthy active female participants, aged between 18 and 35 years, will be randomized to either an experimental (heat acclimation and exercise training) or control (thermo-neutral exercise training) group. The experimental group will complete a 10-day heat acclimation training intervention, exercising for 60 minutes per day in a climactic chamber set to 35°C and 50% relative humidity. The control group will complete a similar exercise intervention, but under thermo-neutral conditions (23°C and 50% relative humidity). Before and after the intervention period, both groups will complete a wide variety of tests, including exercise capacity measurements under each environmental condition (heat \[35°C\], hypoxia \[Fraction of inspired oxygen = 0.135\], neutral \[23°C, FiO2 = 0.209\]), body composition assessments, lung function testing, hemoglobin mass and blood volume quantification, skeletal muscle mitochondrial function and vascular responsiveness assessment, and venous blood sampling for a variety of sex hormone-, redox balance-, hematopoietic-, heat shock protein-, hypoxia-inducible factor- and genetic-related markers.

Conditions

Interventions

TypeNameDescription
OTHERHeat acclimation and exercise training10-day intervention consisting of daily 60-min exercise sessions aimed to induce increases in core body temperature, conducted in a climactic chamber set to 35°C and 50% relative humidity.
OTHERThermo-neutral exercise training group10-day intervention consisting of daily 60-min exercise sessions conducted in a climactic chamber set to 23°C and 50% relative humidity.

Timeline

Start date
2024-10-01
Primary completion
2024-12-01
Completion
2024-12-01
First posted
2024-08-28
Last updated
2024-08-28

Locations

2 sites across 1 country: Slovenia

Source: ClinicalTrials.gov record NCT06575985. Inclusion in this directory is not an endorsement.