Heat-suit Endurance TrainingHeatMENCT04611646
Effects of Heat-suit Training on Biological and Performance Characteristics in Elite Cyclists
A study testing Heat-suit endurance training and Non-heat-suit endurance training in people with Heat-suit Endurance Training and Non-heat-suit Endurance Training, run by Inland Norway University of Applied Sciences at 1 site in Norway.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat-suit Endurance Training, Non-heat-suit Endurance Training
- What is being tested?
- Heat-suit endurance training and Non-heat-suit endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteNorway
- Study dates
- 19 Oct 2020to 13 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Inland Norway University of Applied Sciences
Lillehammer, Inland Norway, 2613
About this study
Official title: 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
Read the 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.
- Being tested
- Heat-suit endurance training, Non-heat-suit endurance training
- Keywords
- Cycling, Heat, Hemoglobin mass, Skeletal muscle, Elite cyclists, Endurance performance, Mitochondria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat-suit endurance trainingBehavioural
Also called Heat 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
Non-heat-suit endurance trainingBehavioural
Also called Control group
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
| Study group | Role | What they receive |
|---|---|---|
| Heat-suit training | Experimental | Low-intensity endurance training with heat suit Receives: Behavioral: Heat-suit endurance training |
| Non-heat-suit training | Other | Low-intensity endurance training without heat suit Receives: Behavioral: Non-heat-suit endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin mass
Hemoglobin mass measured using CO rebreathing (g)
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary outcomes (23)
Maximal oxygen consumption
Maximal oxygen consumption measured during an incremental cycling exercise test to exhaustion
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Maximal aerobic power output
Maximal aerobic power output measured as mean power output during the last minute of an incremental cycling exercise test to exhaustion
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Power output at lactate threshold
Power output at 4 mmol blood lactate concentration measured during an incremental cycling exercise test (with 5 minute steps)
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Gross efficiency
Contribution of total energy turnover to power output in the fresh and fatigued state
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Fractional utilization of VO2max (incremental test)
Fractional utilization of VO2max measured at 4 mmol blood lactate concentrations measured during an incremental cycling exercise test (with 5 minute steps)
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Fractional utilization of VO2max (15-minute performance test)
Fractional utilization of VO2max measured during a 15-minute performance test
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Sprint performance
Mean power output measured during a 10-second all-out cycling sprint
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Performance during a 15-minute all-out cycling test
Mean power output measured during a 15-minute all-out cycling test
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Performance during a 40-minute all-out cycling test
Mean power output measured during a 40-minute all-out cycling test
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Maximal concentric force production
Maximal concentric force production measured using a seated leg press test
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Gene expression in skeletal muscle
RNA abundances in m. vastus lateralis measured using qPCR (e.g. messenger RNA and ribosomal RNA)
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Mitochondrial respiration in skeletal muscle
The ability of muscle mitochondria (extracted from homogenate; m. vastus lateralis) to consume oxygen in vitro
Measured: Immediately after the intervention (T1)
Mitochondrial content in skeletal muscle
Mitochondria content in m. vastus lateralis measured using electron microscopy
Measured: Immediately after the intervention (T1)
Total RNA content in skeletal muscle
Total RNA content in m. vastus lateralis (per unit tissue weight) measured using spectrophotometry
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Blood volume
Blood volume measured using CO rebreathing
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Plasma volume
Plasma volume measured using CO rebreathing
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Red blood cell volume
Red blood cell volume measured using CO rebreathing
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Hematocrit
Hematocrit measured using centrifugation
Measured: Changes from before the intervention (T0) to immediately after the intervention (T1)
Hemoglobin mass
Hemoglobin mass measured using CO rebreathing (g)
Measured: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Blood volume
Blood volume measured using CO rebreathing
Measured: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Plasma volume
Plasma volume measured using CO rebreathing
Measured: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Red blood cell volume
Red blood cell volume measured using CO rebreathing
Measured: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Hematocrit
Hematocrit measured using centrifugation
Measured: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start19 Oct 2020
- Primary completion13 Dec 2020
- Study completion13 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat-suit Endurance TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted as a five-week intervention. In the heat-suit arm, participants will conduct a 50-minute low-intensity cycling session with heat suit five time a week. In the none-heat-suit arm, participants will conduct similar amounts of low-intensity cycling without heat suit. These training sessions will complement the habitual training of the participants. Participants will be allocated into the two arms in a planned randomized manner. In short, participants will be stratified based on baseline performance levels (VO2max), whereby they will be allocated into the two intervention arms in a manner that ensures similar average performance levels between the two arms.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inland Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne S Lofthus, Study chair, Research Administrator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611646
- Sponsor's protocol ID
- Trainome 2020#025
- Acronym
- HeatME
- Status last verified
- Nov 2020
- First submitted
- 20 Oct 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heat-suit Training on Training-associated Changes in Hemoglobin Mass, Muscle Characteristics and Endurance Performance in Elite Cyclists
- ClinicalTrials.gov ID
- NCT04611646
- Acronym / sponsor ID
- HeatME / Trainome 2020#025
- Keywords
- Cycling, Heat, Hemoglobin mass, Skeletal muscle, Elite cyclists, Endurance performance, Mitochondria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Inland Norway University of Applied SciencesUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 13 Dec 2020 (actual)
- Study completion
- 13 Dec 2020 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted as a five-week intervention. In the heat-suit arm, participants will conduct a 50-minute low-intensity cycling session with heat suit five time a week. In the none-heat-suit arm, participants will conduct similar amounts of low-intensity cycling without heat suit. These training sessions will complement the habitual training of the participants. Participants will be allocated into the two arms in a planned randomized manner. In short, participants will be stratified based on baseline performance levels (VO2max), whereby they will be allocated into the two intervention arms in a manner that ensures similar average performance levels between the two arms.
| Arm | Type | Receives |
|---|---|---|
| Heat-suit training | Experimental | Behavioral: Heat-suit endurance trainingLow-intensity endurance training with heat suit |
| Non-heat-suit training | Other | Behavioral: Non-heat-suit endurance trainingLow-intensity endurance training without heat suit |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat-suit endurance trainingAlso: Heat trainingParticipants (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 | Behavioural | Heat-suit training |
| Non-heat-suit endurance trainingAlso: Control groupParticipants (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 | Behavioural | Non-heat-suit training |
Primary outcome
Hemoglobin mass
Time frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Hemoglobin mass measured using CO rebreathing (g)
23 secondary outcomes
Maximal oxygen consumption
Time frame: 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)
Power output at lactate threshold
Time frame: 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)
Fractional utilization of VO2max (incremental test)
Time frame: 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)
Sprint performance
Time frame: 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)
Performance during a 40-minute all-out cycling test
Time frame: 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)
Gene expression in skeletal muscle
Time frame: Changes from before the intervention (T0) to immediately after the intervention (T1)
Mitochondrial respiration in skeletal muscle
Time frame: Immediately after the intervention (T1)
Mitochondrial content in skeletal muscle
Time frame: 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)
Blood volume
Time frame: 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)
Red blood cell volume
Time frame: 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)
Hemoglobin mass
Time frame: 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)
Plasma volume
Time frame: 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)
Hematocrit
Time frame: Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne S Lofthus study chair
Research Administrator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat-suit endurance training and Non-heat-suit endurance training in people with Heat-suit Endurance Training and Non-heat-suit Endurance Training, run by Inland Norway University of Applied Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin mass (time frame: Changes from before the intervention (T0) to immediately after the intervention (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.