Viewing Study NCT06575985



Ignite Creation Date: 2024-10-25 @ 7:52 PM
Last Modification Date: 2024-10-26 @ 3:39 PM
Study NCT ID: NCT06575985
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-21

Brief Title: Mechanisms Underlying Hypoxic Heat and Cross-tolerance Adaptation in Women
Sponsor: None
Organization: None

Study Overview

Official Title: Investigating the Effects of a 10-day Heat Acclimation and Exercise Intervention on Physiological Adaptations and Cross-tolerance in Women
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FemAdapt_HOT
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 acclimationacclimatization 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 acclimationacclimatization 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 35C and 50 relative humidity The control group will complete a similar exercise intervention but under thermo-neutral conditions 23C 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 35C hypoxia Fraction of inspired oxygen 0135 neutral 23C FiO2 0209 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None