Effects of Heat-suit Training on Biological and Performance Characteristics in Elite Cyclists (HeatME)

February 26, 2021 updated by: Inland Norway University of Applied Sciences

Effects of Heat-suit Training on Training-associated Changes in Hemoglobin Mass, Muscle Characteristics and Endurance Performance in Elite Cyclists

The overall objective of the study is to investigate the effects of five weeks of heat-suit training on training-associated changes in hemoglobin mass, skeletal muscle characteristics and endurance exercise performance in elite cyclists

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Endurance exercise performance depends on a range of determinants, including hemoglobin mass in blood and content of respiratory mitochondria in skeletal muscle. Low-intensity training (LIT) with heat exposure may be beneficial for development of these variables. The purpose of this study is to investigate the effects of five weeks of LIT-training with heat suit (five times a week; 50 min per session) on hemoglobin mass and other blood characteristics in elite cyclists (males and females) compared to a non-heat-suit training control group, including subsequent investigation of the retrograde effects of ~one month of training without heat suit. The study will also investigate the effects of heat-suit training on endurance exercise performance/performance determinants and other muscle biological charateristics, and will investigate the basic characteristics of mitochondrial function and abundances in these highly trained athletes. Training sessions with heat suit (or lack thereof) will complement the habitual training routines of the participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Inland Norway
      • Lillehammer, Inland Norway, Norway, 2613
        • Inland Norway University of Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • VO2max > 65 ml/kg/min (male participants)
  • VO2max > 50 ml/kg/min (female participants)
  • >7 hours of endurance training per week for the 6 months leading up to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Heat-suit training
Low-intensity endurance training with heat suit
Behavioral: Heat-suit endurance training
Participants (elite cyclists) will conduct five 50-minute low-intensity cycling sessions with heat suit per week for five weeks. These sessions will complement their habitual training routines, which will consist of endurance training with intensities at or below lactate threshold. Participants will ingest 100 mg Fe2+ on a daily basis to support de novo synthesis of hemoglobin
Other Names:
  • Heat training
Other: Non-heat-suit training
Low-intensity endurance training without heat suit
Behavioral: Non-heat-suit endurance training
Participants (elite cyclists) will conduct low-intensity cycling without heat suit for five weeks (volume- and intensity-matched to the heat-suit arm). Participants will ingest 100 mg Fe2+ on a daily basis to support de novo synthesis of hemoglobin
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemoglobin mass
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Hemoglobin mass measured using CO rebreathing (g)
Changes from before the intervention (T0) to immediately after the intervention (T1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximal oxygen consumption
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Maximal oxygen consumption measured during an incremental cycling exercise test to exhaustion
Changes from before the intervention (T0) to immediately after the intervention (T1)
Maximal aerobic power output
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Maximal aerobic power output measured as mean power output during the last minute of an incremental cycling exercise test to exhaustion
Changes from before the intervention (T0) to immediately after the intervention (T1)
Power output at lactate threshold
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Power output at 4 mmol blood lactate concentration measured during an incremental cycling exercise test (with 5 minute steps)
Changes from before the intervention (T0) to immediately after the intervention (T1)
Gross efficiency
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Contribution of total energy turnover to power output in the fresh and fatigued state
Changes from before the intervention (T0) to immediately after the intervention (T1)
Fractional utilization of VO2max (incremental test)
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Fractional utilization of VO2max measured at 4 mmol blood lactate concentrations measured during an incremental cycling exercise test (with 5 minute steps)
Changes from before the intervention (T0) to immediately after the intervention (T1)
Fractional utilization of VO2max (15-minute performance test)
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Fractional utilization of VO2max measured during a 15-minute performance test
Changes from before the intervention (T0) to immediately after the intervention (T1)
Sprint performance
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Mean power output measured during a 10-second all-out cycling sprint
Changes from before the intervention (T0) to immediately after the intervention (T1)
Performance during a 15-minute all-out cycling test
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Mean power output measured during a 15-minute all-out cycling test
Changes from before the intervention (T0) to immediately after the intervention (T1)
Performance during a 40-minute all-out cycling test
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Mean power output measured during a 40-minute all-out cycling test
Changes from before the intervention (T0) to immediately after the intervention (T1)
Maximal concentric force production
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Maximal concentric force production measured using a seated leg press test
Changes from before the intervention (T0) to immediately after the intervention (T1)
Gene expression in skeletal muscle
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
RNA abundances in m. vastus lateralis measured using qPCR (e.g. messenger RNA and ribosomal RNA)
Changes from before the intervention (T0) to immediately after the intervention (T1)
Mitochondrial respiration in skeletal muscle
Time Frame: Immediately after the intervention (T1)
The ability of muscle mitochondria (extracted from homogenate; m. vastus lateralis) to consume oxygen in vitro
Immediately after the intervention (T1)
Mitochondrial content in skeletal muscle
Time Frame: Immediately after the intervention (T1)
Mitochondria content in m. vastus lateralis measured using electron microscopy
Immediately after the intervention (T1)
Total RNA content in skeletal muscle
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Total RNA content in m. vastus lateralis (per unit tissue weight) measured using spectrophotometry
Changes from before the intervention (T0) to immediately after the intervention (T1)
Blood volume
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Blood volume measured using CO rebreathing
Changes from before the intervention (T0) to immediately after the intervention (T1)
Plasma volume
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Plasma volume measured using CO rebreathing
Changes from before the intervention (T0) to immediately after the intervention (T1)
Red blood cell volume
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Red blood cell volume measured using CO rebreathing
Changes from before the intervention (T0) to immediately after the intervention (T1)
Hematocrit
Time Frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Hematocrit measured using centrifugation
Changes from before the intervention (T0) to immediately after the intervention (T1)
Hemoglobin mass
Time Frame: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Hemoglobin mass measured using CO rebreathing (g)
Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Blood volume
Time Frame: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Blood volume measured using CO rebreathing
Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Plasma volume
Time Frame: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Plasma volume measured using CO rebreathing
Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Red blood cell volume
Time Frame: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Red blood cell volume measured using CO rebreathing
Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Hematocrit
Time Frame: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Hematocrit measured using centrifugation
Changes from immediately after the intervention (T1) to one month after the intervention (T2)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Training volume
Time Frame: Throughout study completion (daily), an average of five weeks
Self-reported training volume measured as time-spent in different exercise intensity zones
Throughout study completion (daily), an average of five weeks
Iron intake
Time Frame: Throughout study completion (daily), an average of five weeks
Self-reported intake of iron supplements
Throughout study completion (daily), an average of five weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inland Norway University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Trainome 2020#025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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