NCT06872762

Brief Summary

Life in space is completely void of physical and environmental stress. It is well known that living things need regular physical stress (e.g. exercise) to remain strong, functional and healthy. More and more research is showing that regular environmental stress, for example heat and hypoxia, can further improve physical health. Astronauts aboard the international space station (ISS) exercise for 1-2 hours every day to avoid physical deconditioning that would otherwise cause them to age rapidly in space. Although physical exercise is very effective in remedying this deconditioning, today's astronauts still have physiological changes that indicate accelerated aging. This is a cause for concern given NASA's priority to travel to mars within the next decade; a mission that will require at least double the duration in space for our astronauts. The investigators think that the complete absence of environmental stress, i.e., heat, may be contributing to the accelerated aging that occurs during spaceflight. Our study will assess the health effects of adding heat stress to exercise that could be performed in space by astronauts. The goal is to inform best practice for astronauts to avoid physical deconditioning during long-duration spaceflight. This information will also be relevant to life on earth as spaceflight is a model of inactivity here on earth. Therefore, the potential benefits of adding heat stress will likely translate to life in space and on earth.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Mar 2025May 2026

First Submitted

Initial submission to the registry

February 24, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2026

Expected
Last Updated

March 12, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

February 24, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

exerciseheat strainglucose tolerance testarterial compliance

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance

    Glucose to insulin concentration ratio in serum.

    2 hours after intervention complete

Secondary Outcomes (2)

  • Arterial compliance

    2 hours after intervention complete

  • Plasma volume expansion

    24 hours after intervention

Study Arms (3)

Exercise

EXPERIMENTAL

Participants exercise for 90 minutes trying to remain cool with fans and limited clothing.

Behavioral: ExerciseBehavioral: Heat strain

Heat strain

EXPERIMENTAL

Participants exercise for 90 minutes wearing winter and rain clothes to develop heat strain.

Behavioral: ExerciseBehavioral: Heat strain

Control

PLACEBO COMPARATOR

Resting control for 90 minutes. Not allowed to exercise.

Behavioral: ExerciseBehavioral: Heat strain

Interventions

ExerciseBEHAVIORAL

Exercise for 90 minutes (cycling) while minimizing thermal strain

ControlExerciseHeat strain
Heat strainBEHAVIORAL

Exercise for 90 minutes (cycling) while maximizing thermal strain

ControlExerciseHeat strain

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • regularly physically active as determined via ParQ+

You may not qualify if:

  • smokers
  • bronchial asthma
  • chronic obstructive pulmonary disease
  • obese
  • alcoholism
  • requiring daily medications that may effect responses to exercise,
  • anti-arrhythmogenics
  • inhalers
  • history of cardiovascular, respiratory, neurological, skeletal muscle disease
  • irregular/absent menstrual cycle (females)
  • unexpected responses to pre-experimental exercise tests
  • previous diagnosis of heat stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Travis Gibbons, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Researchers will be masked to data during analysis.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Random order, repeated measures, cross-over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 12, 2025

Study Start

March 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

May 21, 2026

Last Updated

March 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

I am concerned for privacy protection of our participants.

Locations