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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04611646
Other study ID # Trainome 2020#025
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2020
Est. completion date December 13, 2020

Study information

Verified date November 2020
Source Inland Norway University of Applied Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date December 13, 2020
Est. primary completion date December 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

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
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

Locations

Country Name City State
Norway Inland Norway University of Applied Sciences Lillehammer Inland Norway

Sponsors (1)

Lead Sponsor Collaborator
Inland Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Training volume Self-reported training volume measured as time-spent in different exercise intensity zones Throughout study completion (daily), an average of five weeks
Other Iron intake Self-reported intake of iron supplements Throughout study completion (daily), an average of five weeks
Primary Hemoglobin mass Hemoglobin mass measured using CO rebreathing (g) Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Maximal oxygen consumption Maximal oxygen consumption measured during an incremental cycling exercise test to exhaustion Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary 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 Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Power output at lactate threshold 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)
Secondary Gross efficiency 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)
Secondary 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) Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Fractional utilization of VO2max (15-minute performance test) Fractional utilization of VO2max measured during a 15-minute performance test Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Sprint performance Mean power output measured during a 10-second all-out cycling sprint Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Performance during a 15-minute all-out cycling test Mean power output measured during a 15-minute all-out cycling test Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Performance during a 40-minute all-out cycling test Mean power output measured during a 40-minute all-out cycling test Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Maximal concentric force production Maximal concentric force production measured using a seated leg press test Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Gene expression in skeletal muscle 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)
Secondary Mitochondrial respiration in skeletal muscle The ability of muscle mitochondria (extracted from homogenate; m. vastus lateralis) to consume oxygen in vitro Immediately after the intervention (T1)
Secondary Mitochondrial content in skeletal muscle Mitochondria content in m. vastus lateralis measured using electron microscopy Immediately after the intervention (T1)
Secondary Total RNA content in skeletal muscle 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)
Secondary Blood volume Blood volume measured using CO rebreathing Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Plasma volume Plasma volume measured using CO rebreathing Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Red blood cell volume Red blood cell volume measured using CO rebreathing Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Hematocrit Hematocrit measured using centrifugation Changes from before the intervention (T0) to immediately after the intervention (T1)
Secondary Hemoglobin mass Hemoglobin mass measured using CO rebreathing (g) Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Secondary Blood volume Blood volume measured using CO rebreathing Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Secondary Plasma volume Plasma volume measured using CO rebreathing Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Secondary Red blood cell volume Red blood cell volume measured using CO rebreathing Changes from immediately after the intervention (T1) to one month after the intervention (T2)
Secondary Hematocrit Hematocrit measured using centrifugation Changes from immediately after the intervention (T1) to one month after the intervention (T2)