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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Heat Exposure Exercise Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Heat acclimation and exercise group

Experimental group who will complete an exercise training intervention under hot conditions

Group Type EXPERIMENTAL

Heat acclimation and exercise training

Intervention Type 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.

Thermo-neutral exercise training group

Control group who will complete an exercise training intervention under thermo-neutral conditions

Group Type ACTIVE_COMPARATOR

Thermo-neutral exercise training group

Intervention Type OTHER

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

Interventions

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Heat 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.

Intervention Type OTHER

Thermo-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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes