NCT04611646

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2020

Completed
Last Updated

March 1, 2021

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

October 20, 2020

Last Update Submit

February 26, 2021

Conditions

Keywords

CyclingHeatHemoglobin massSkeletal muscleElite cyclistsEndurance performanceMitochondria

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin mass

    Hemoglobin mass measured using CO rebreathing (g)

    Changes from before the intervention (T0) to immediately after the intervention (T1)

Secondary Outcomes (23)

  • Maximal oxygen consumption

    Changes from before the intervention (T0) to immediately after the intervention (T1)

  • Maximal aerobic power output

    Changes from before the intervention (T0) to immediately after the intervention (T1)

  • Power output at lactate threshold

    Changes from before the intervention (T0) to immediately after the intervention (T1)

  • Gross efficiency

    Changes from before the intervention (T0) to immediately after the intervention (T1)

  • Fractional utilization of VO2max (incremental test)

    Changes from before the intervention (T0) to immediately after the intervention (T1)

  • +18 more secondary outcomes

Other Outcomes (2)

  • Training volume

    Throughout study completion (daily), an average of five weeks

  • Iron intake

    Throughout study completion (daily), an average of five weeks

Study Arms (2)

Heat-suit training

EXPERIMENTAL

Low-intensity endurance training with heat suit

Behavioral: Heat-suit endurance training

Non-heat-suit training

OTHER

Low-intensity endurance training without heat suit

Behavioral: Non-heat-suit endurance training

Interventions

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

Also known as: Heat training
Heat-suit 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

Also known as: Control group
Non-heat-suit training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inland Norway University of Applied Sciences

Lillehammer, Inland Norway, 2613, Norway

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Anne S Lofthus

    Research Administrator

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2020

First Posted

November 2, 2020

Study Start

October 19, 2020

Primary Completion

December 13, 2020

Study Completion

December 13, 2020

Last Updated

March 1, 2021

Record last verified: 2020-11

Locations