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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06575985
Acronym
FemAdapt_HOT
Enrollment
30
Registered
2024-08-28
Start date
2024-10-31
Completion date
2024-12-31
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Training, Heat Exposure

Brief 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.

Interventions

OTHERHeat acclimation and exercise training

10-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 group

10-day intervention consisting of daily 60-min exercise sessions conducted in a climactic chamber set to 23°C and 50% relative humidity.

Sponsors

University of Ljubljana
CollaboratorOTHER
University of Ljubljana, Faculty of Medicine
CollaboratorOTHER
Jozef Stefan Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Masking description

Considering that the heat acclimation condition will be easily perceptible to the participants, it will not be possible to blind them from their group assignment. The investigators will also be required to set the environmental conditions for each exercise session, so they will also be aware of group assignment during the intervention. However, efforts will be made to blind outcomes assessors to group assignment, by reassigning unique participant identifier codes with the random assignment of A and B to the experimental and control groups by a third party. The experimental and control group can therefore be compared, without knowledge of which label corresponds to which group until after data processing and statistical analyses have been performed.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Age: 18 - 35 years * Body mass index: 18.5 - 25.0 kg/m\^2 * Regular physical activity (at least 30 minutes of moderate-intensity activity, three times per week)

Exclusion criteria

* Habitual smoker within the past 5 years * History of metabolic disorders or any medications deemed to pose an undue risk or introduce bias in any outcome measures * Exposure to altitude \> 2000 m above sea level within four weeks of scheduled participation * Permanent residence at altitude \> 1000 m above sea level

Design outcomes

Primary

MeasureTime frameDescription
Exercise capacity under thermo-neutral hypoxic conditionsMeasured once before (pre) and once up to 1 week after (post) the intervention periodResults of an incremental exercise test to exhaustion conducted at 23°C and an FiO2 of 0.135, quantified using maximal oxygen uptake
Exercise capacity under hot normoxic conditionsMeasured once before (pre) and once up to 1 week after (post) the intervention periodResults of an incremental exercise test to exhaustion conducted at 35°C and an FiO2 of 0.209, quantified using maximal oxygen uptake
Exercise capacity under thermo-neutral normoxic conditionsMeasured once before (pre) and once up to 1 week after (post) the intervention periodResults of an incremental exercise test to exhaustion conducted at 23°C and an FiO2 of 0.209, quantified using maximal oxygen uptake

Secondary

MeasureTime frameDescription
Sweat rates during exerciseMeasured once before (pre) and once up to 1 week after (post) the intervention periodSweat rate measured throughout the incremental exercise tests using a sensor attached to the forehead.
Hemo-dynamic activity during exerciseMeasured once before (pre) and once up to 1 week after (post) the intervention periodCardiac output measured throughout the incremental exercise tests by bio-electrical impedance cardiography.
Pulmonary ventilation during exerciseMeasured once before (pre) and once up to 1 week after (post) the intervention periodPulmonary ventilation measured throughout the incremental exercise tests using flow measurements as recorded by metabolic cart.
Gas exchange during exerciseMeasured once before (pre) and once up to 1 week after (post) the intervention periodBalance of oxygen uptake and carbon dioxide production measured throughout the incremental exercise tests using gas composition sensors recorded by metabolic cart.
Muscle oxygenation during exerciseMeasured once before (pre) and once up to 1 week after (post) the intervention periodVastus lateralis oxygenation measured throughout the incremental exercise tests using near-infrared spectroscopy.
Brain oxygenation during exerciseMeasured once before (pre) and once up to 1 week after (post) the intervention periodCerebral oxygenation measured at the left pre-frontal cortex throughout the incremental exercise tests using near-infrared spectroscopy.
Pulse oxygen saturation during exerciseMeasured once before (pre) and once up to 1 week after (post) the intervention periodCapillary oxygen saturation measured on the right earlobe throughout the incremental exercise tests using pulse oximetry.
Body compositionMeasured once before (pre) and once up to 1 week after (post) the intervention periodBody mass measured using standard weighing scales, with body fat percentage estimated using a standardized eight-site skinfold measurement protocol with associated equation.
Hemoglobin massMeasured once before (pre) and once up to 1 week after (post) the intervention periodHemoglobin mass estimation using the carbon monoxide re-breathing method
Blood/plasma volumeMeasured once before (pre) and once up to 1 week after (post) the intervention periodBlood/plasma volume estimation using the carbon monoxide re-breathing method
Skeletal muscle mitochondrial functionMeasured once before (pre) and once up to 1 week after (post) the intervention periodSkeletal muscle mitochondrial function quantified using a peripheral vascular occlusion test, with the rate of decrease in muscle oxygenation used to estimate mitochondrial function.
Skeletal muscle vascular responsivenessMeasured once before (pre) and once up to 1 week after (post) the intervention periodSkeletal muscle vascular responsiveness quantified using a peripheral vascular occlusion test, with the rate of increase in muscle oxygenation during re-perfusion, and the oxygenation overshoot relative to pre-occlusion baseline, used to estimate vascular responsiveness.
Blood viscosityMeasured once before (pre) and once up to 1 week after (post) the intervention periodBlood viscosity will be measured by obtaining venous blood samples from the participants, extracting plasma, and using a cone/plate viscometer to quantify viscosity and varying shear rates.
Oxidative stress markerMeasured once before (pre) and once up to 1 week after (post) the intervention periodVenous blood samples will be obtained to quantify redox balance from the extracted plasma.
HematopoiesisMeasured once before (pre) and once up to 1 week after (post) the intervention periodVenous blood samples will be obtained to measure various markers of hematopoiesis from the extracted plasma, serum and/or whole blood.
Heat shock proteinsMeasured once before (pre) and once up to 1 week after (post) the intervention periodVenous blood samples will be obtained to measure heat shock proteins in the extracted plasma and serum.
Hypoxia-inducible factor 1αMeasured once before (pre) and once up to 1 week after (post) the intervention periodVenous blood samples will be obtained to measure hypoxia-inducible factor 1α in the extracted plasma and serum.
Lung functionMeasured once before (pre) and once up to 1 week after (post) the intervention periodStandard spirometry procedure to assess lung function using forced expiratory volume
Core body temperature regulation during exerciseMeasured once before (pre) and once up to 1 week after (post) the intervention periodCore body temperature measured throughout the incremental exercise tests using a rectal temperature probe.
Skin temperature regulation during exerciseMeasured once before (pre) and once up to 1 week after (post) the intervention periodSkin temperature measured throughout the incremental exercise tests using temperature probes attached to the calf, thigh, chest and arm, from which weighted averages are calculated.

Other

MeasureTime frameDescription
OestrogenMeasured once before (pre) and once up to 1 week after (post) the intervention periodOestrogen will be quantified in the plasma extracted from venous blood samples, to identify the menstrual cycle phases of the participants.
Single nucleotide polymorphismsMeasured once before (pre) and once up to 1 week after (post) the intervention periodVenous blood samples will be processed and analysed to identify single nucleotide polymorphisms
ProgesteroneMeasured once before (pre) and once up to 1 week after (post) the intervention periodProgesterone will be quantified in the plasma extracted from venous blood samples, to identify the menstrual cycle phases of the participants.

Countries

Slovenia

Contacts

Primary ContactTadej Debevec, PhD
tadej.debevec@fsp.uni-lj.si+38615207726
Backup ContactBenjamin J Narang, MSci
benjamin.narang@ijs.si+38640569967

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026