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| ID | Type | Description | Link |
|---|---|---|---|
| J5-50180 | Other Grant/Funding Number | Javna Agencija za Raziskovalno Dejavnost RS |
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| Name | Class |
|---|---|
| University of Ljubljana | OTHER |
| University of Ljubljana, Faculty of Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat acclimation and exercise group | Experimental | Experimental group who will complete an exercise training intervention under hot conditions |
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| Thermo-neutral exercise training group | Active Comparator | Control group who will complete an exercise training intervention under thermo-neutral conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat acclimation and exercise training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity under thermo-neutral normoxic conditions | Results of an incremental exercise test to exhaustion conducted at 23°C and an FiO2 of 0.209, quantified using maximal oxygen uptake | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Exercise capacity under hot normoxic conditions | Results of an incremental exercise test to exhaustion conducted at 35°C and an FiO2 of 0.209, quantified using maximal oxygen uptake | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Exercise capacity under thermo-neutral hypoxic conditions | Results of an incremental exercise test to exhaustion conducted at 23°C and an FiO2 of 0.135, quantified using maximal oxygen uptake | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Core body temperature regulation during exercise | Core body temperature measured throughout the incremental exercise tests using a rectal temperature probe. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Skin temperature regulation during exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Oestrogen | Oestrogen will be quantified in the plasma extracted from venous blood samples, to identify the menstrual cycle phases of the participants. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Progesterone |
Inclusion Criteria:
Exclusion Criteria:
Participants will be recruited based on their self-identification as female. Sex hormone measurements will later be conducted to verify alignment between their gender identity and biological sex.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tadej Debevec, PhD | Contact | +38615207726 | tadej.debevec@fsp.uni-lj.si | |
| Benjamin J Narang, MSci | Contact | +38640569967 | benjamin.narang@ijs.si |
| Name | Affiliation | Role |
|---|---|---|
| Tadej Debevec, PhD | University of Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jozef Stefan Institute | Ljubljana | SI | 1000 | Slovenia |
All of the individual participant data collected during the study, after de-identification, will be made publicly available using an online data repository.
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Data will be made available immediately following publication with no end date.
Any purpose.
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
| Thermo-neutral exercise training group | Other | 10-day intervention consisting of daily 60-min exercise sessions conducted in a climactic chamber set to 23°C and 50% relative humidity. |
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Skin temperature measured throughout the incremental exercise tests using temperature probes attached to the calf, thigh, chest and arm, from which weighted averages are calculated. |
| Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Sweat rates during exercise | Sweat rate measured throughout the incremental exercise tests using a sensor attached to the forehead. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Hemo-dynamic activity during exercise | Cardiac output measured throughout the incremental exercise tests by bio-electrical impedance cardiography. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Pulmonary ventilation during exercise | Pulmonary ventilation measured throughout the incremental exercise tests using flow measurements as recorded by metabolic cart. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Gas exchange during exercise | Balance of oxygen uptake and carbon dioxide production measured throughout the incremental exercise tests using gas composition sensors recorded by metabolic cart. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Muscle oxygenation during exercise | Vastus lateralis oxygenation measured throughout the incremental exercise tests using near-infrared spectroscopy. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Brain oxygenation during exercise | Cerebral oxygenation measured at the left pre-frontal cortex throughout the incremental exercise tests using near-infrared spectroscopy. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Pulse oxygen saturation during exercise | Capillary oxygen saturation measured on the right earlobe throughout the incremental exercise tests using pulse oximetry. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Body composition | Body mass measured using standard weighing scales, with body fat percentage estimated using a standardized eight-site skinfold measurement protocol with associated equation. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Lung function | Standard spirometry procedure to assess lung function using forced expiratory volume | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Hemoglobin mass | Hemoglobin mass estimation using the carbon monoxide re-breathing method | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Blood/plasma volume | Blood/plasma volume estimation using the carbon monoxide re-breathing method | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Skeletal muscle mitochondrial function | Skeletal muscle mitochondrial function quantified using a peripheral vascular occlusion test, with the rate of decrease in muscle oxygenation used to estimate mitochondrial function. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Skeletal muscle vascular responsiveness | Skeletal 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. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Blood viscosity | Blood 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. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Oxidative stress marker | Venous blood samples will be obtained to quantify redox balance from the extracted plasma. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Hematopoiesis | Venous blood samples will be obtained to measure various markers of hematopoiesis from the extracted plasma, serum and/or whole blood. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Heat shock proteins | Venous blood samples will be obtained to measure heat shock proteins in the extracted plasma and serum. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Hypoxia-inducible factor 1α | Venous blood samples will be obtained to measure hypoxia-inducible factor 1α in the extracted plasma and serum. | Measured once before (pre) and once up to 1 week after (post) the intervention period |
Progesterone will be quantified in the plasma extracted from venous blood samples, to identify the menstrual cycle phases of the participants.
| Measured once before (pre) and once up to 1 week after (post) the intervention period |
| Single nucleotide polymorphisms | Venous blood samples will be processed and analysed to identify single nucleotide polymorphisms | Measured once before (pre) and once up to 1 week after (post) the intervention period |
| University of Ljubljana | Ljubljana | 1000 | Slovenia |