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

NCT06575985 | Not Yet Recruiting

• 2 other identifiers: FemAdapt_HEATJ5-50180
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Heat Exposure; Exercise Training

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (20)

• Core body temperature regulation during exercise

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

• Skin temperature regulation during exercise

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

• Sweat rates during exercise

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

• Hemo-dynamic activity during exercise

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

• Pulmonary ventilation during exercise

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

Other Outcomes (3)

• Oestrogen

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

• Progesterone

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

• Single nucleotide polymorphisms

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

Study Arms (2)

Heat acclimation and exercise group

EXPERIMENTAL

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

Other: Heat acclimation and exercise training

Thermo-neutral exercise training group

ACTIVE COMPARATOR

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

Other: Thermo-neutral exercise training group

Interventions

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.

Heat acclimation and exercise group

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.

Thermo-neutral exercise training group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jozef Stefan Institute: lead
• University of Ljubljana: collaborator
• University of Ljubljana, Faculty of Medicine: collaborator

Study Sites (2)

Jozef Stefan Institute

Ljubljana, SI, 1000, Slovenia

Location

University of Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tadej Debevec, PhD

  University of Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tadej Debevec, PhD

CONTACT

+38615207726; tadej.debevec@fsp.uni-lj.si

Benjamin J Narang, MSci

CONTACT

+38640569967; benjamin.narang@ijs.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 28, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available immediately following publication with no end date.
• Access Criteria: Any purpose.

Locations

SL (2)