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

ConditionsHeat ExposureExercise Training
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorJozef Stefan Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18 - 35 years

Body mass index: 18.5 - 25.0 kg/m²

Regular physical activity (at least 30 minutes of moderate-intensity activity, three times per week)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Heat acclimation and exercise training

    Other intervention

    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

    Other intervention

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Heat acclimation and exercise groupExperimental treatment 1 intervention
Group B: Thermo-neutral exercise training groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Measured once before (pre) and once up to 1 week after (post) the intervention period
2

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

Time frame
Measured once before (pre) and once up to 1 week after (post) the intervention period
3

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

Time frame
Measured once before (pre) and once up to 1 week after (post) the intervention period

Secondary outcomes

1

Core body temperature regulation during exercise

Core body temperature measured throughout the incremental exercise tests using a rectal temperature probe.

Time frame
Measured once before (pre) and once up to 1 week after (post) the intervention period
2

Skin temperature regulation during exercise

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.

Time frame
Measured once before (pre) and once up to 1 week after (post) the intervention period
3

Sweat rates during exercise

Sweat rate measured throughout the incremental exercise tests using a sensor attached to the forehead.

Time frame
Measured once before (pre) and once up to 1 week after (post) the intervention period
4

Hemo-dynamic activity during exercise

Cardiac output measured throughout the incremental exercise tests by bio-electrical impedance cardiography.

Time frame
Measured once before (pre) and once up to 1 week after (post) the intervention period

Other outcomes

1

Oestrogen

Oestrogen will be quantified in the plasma extracted from venous blood samples, to identify the menstrual cycle phases of the participants.

Time frame
Measured once before (pre) and once up to 1 week after (post) the intervention period
2

Progesterone

Progesterone will be quantified in the plasma extracted from venous blood samples, to identify the menstrual cycle phases of the participants.

Time frame
Measured once before (pre) and once up to 1 week after (post) the intervention period
3

Single nucleotide polymorphisms

Venous blood samples will be processed and analysed to identify single nucleotide polymorphisms

Time frame
Measured once before (pre) and once up to 1 week after (post) the intervention period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jozef Stefan Institute

Lead sponsor

University of Ljubljana

Collaborator

University of Ljubljana, Faculty of Medicine

Collaborator

Source ClinicalTrials.gov

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