NCT06672614

Brief Summary

The purpose of this study is to determine the effect of 5 days post-exercise hot water immersion on exercise performance at simulated altitude.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

October 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

November 4, 2024

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

October 30, 2024

Last Update Submit

November 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time-Trial Performance in hypoxia conditions

    Results of a 16 km time-trial test conducted at an fraction of inspired oxygen (FiO2) of 0.14

    30 minutes

Secondary Outcomes (4)

  • Pulse oxygen saturation during exercise

    30 minutes

  • Skin temperature during exercise

    90 minutes

  • Core temperature during exercise

    90 minutes

  • Heart Rate during exercise

    90 minutes

Study Arms (2)

Post-Exercise Hot Water Immersion

EXPERIMENTAL

Participants will cycle for 60 minutes at 50% of maximal oxygen uptake (VO2 max) followed by 30 minutes post-exercise hot water immersion (40oC) for 5 consecutive days.

Other: Post-Exercise Hot Water Immersion

Control group

ACTIVE COMPARATOR

Participants will cycle for 60 minutes at 50% of maximal oxygen uptake (VO2 max); however, there will be not water immersion following exercise.

Other: Control Group

Interventions

Participants will cycle for 60 minutes at 50% of maximal oxygen uptake (VO2 max) followed by 30 minutes post-exercise hot water immersion (40oC) for 5 consecutive days.

Post-Exercise Hot Water Immersion

Participants will cycle for 60 minutes at 50% maximal oxygen uptake (VO2 max) for 5 consecutive days. There is no water immersion following the exercise.

Control group

Eligibility Criteria

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

You may qualify if:

  • Physically active (minimum of 90 minutes of moderate-intensity exercise per week)

You may not qualify if:

  • Cardiovascular disease
  • resident of \>1500 m above sea-level in the past year;
  • history of fainting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nipissing University

North Bay, Ontario, P1B 8L7, Canada

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Geoffrey L Hartley, PhD

    Nipissing University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffrey L Hartley, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Considering that the hot water immersion protocol will be easily perceptible to the participants, it will not be possible to blind them from their group assignment. Also, the investigators will be required to set the water temperature for the immersion protocol following each exercise session, so they will also be aware of group assignments during the intervention.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 30, 2024

First Posted

November 4, 2024

Study Start

November 1, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

November 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the study, after de-identification, will be made publicly available using an online data repository.

Shared Documents
SAP, ANALYTIC CODE
Time Frame
Data will be made available immediately following publication with no end date.
Access Criteria
Any purpose.

Locations