- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04611646
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
53
Phase
- 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
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Inland Norway
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Lillehammer, Inland Norway, Norway, 2613
- Inland Norway University of Applied Sciences
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Heat-suit training
Low-intensity endurance training with heat suit
|
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:
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|
Other: Non-heat-suit training
Low-intensity endurance training without heat suit
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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:
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What is the study measuring?
Primary Outcome Measures
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
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
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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)
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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
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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
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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
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Changes from before the intervention (T0) to immediately after the intervention (T1)
|
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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)
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Changes from before the intervention (T0) to immediately after the intervention (T1)
|
|
Mitochondrial respiration in skeletal muscle
Time Frame: Immediately after the intervention (T1)
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The ability of muscle mitochondria (extracted from homogenate; m. vastus lateralis) to consume oxygen in vitro
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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
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Immediately after the intervention (T1)
|
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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
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Changes from before the intervention (T0) to immediately after the intervention (T1)
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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)
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Hematocrit measured using centrifugation
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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)
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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)
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Hematocrit measured using centrifugation
|
Changes from immediately after the intervention (T1) to one month after the intervention (T2)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Training volume
Time Frame: Throughout study completion (daily), an average of five weeks
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Self-reported training volume measured as time-spent in different exercise intensity zones
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Throughout study completion (daily), an average of five weeks
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Iron intake
Time Frame: Throughout study completion (daily), an average of five weeks
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Self-reported intake of iron supplements
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Throughout study completion (daily), an average of five weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 19, 2020
Primary Completion (Actual)
December 13, 2020
Study Completion (Actual)
December 13, 2020
Study Registration Dates
First Submitted
October 20, 2020
First Submitted That Met QC Criteria
October 27, 2020
First Posted (Actual)
November 2, 2020
Study Record Updates
Last Update Posted (Actual)
March 1, 2021
Last Update Submitted That Met QC Criteria
February 26, 2021
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID 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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