NCT04508738

Brief Summary

The objective of the study is to evaluate the effects a complex recovery intervention during the breaks of a repeated sprint test on exercise performance compared to placebo and control conditions. The enhanced recovery package (ERP) includes neck cooling with an iced gel pad, drinking a 6% CHO solution, mouth-rinsing with a 10% CHO, 6 mg・kg -1 caffeine solution, performing submaximal squats and hyperventilating a hyperoxic mixture; all applied in each 3-min break in-between the six 30-s sprints. This intervention will be compared to a placebo and a control condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2020

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

First Submitted

Initial submission to the registry

August 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 2, 2021

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

August 4, 2020

Last Update Submit

June 30, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in mean power output

    Measured over the six 30s high-intensity cycling sprints in each of the three conditions. Mean power mirrors the body's ability to generate muscle power and physical energy. Any meaningful effects of the recovery interventions will eventually translate into a higher power output.

    through study completion, an expected average of 3 weeks per participant

  • Change in fatigue index

    Fatigue index = drop in power output from the beginning to the end a 30s sprint test. The change in this index will be calculated from the 1st to the 6th sprint test in each condition.

    through study completion, an expected average of 3 weeks per participant

Study Arms (3)

ERP Intervention

EXPERIMENTAL

Combination of different methods to improve recovery.

Other: ERP

Control

NO INTERVENTION

Passive recovery by sitting on a chair

Placebo

PLACEBO COMPARATOR

A combination of methods similar to the ERP intervention but at an intensity / mixture supposed to be ineffective at improving recovery.

Other: Placebo

Interventions

ERPOTHER

The ERP intervention is applied in a randomized and counter-balanced order across visits 2-4 in each 3-min break in-between the six 30-s sprints, with one intervention per visit. The order and timing of the constituents of the interventions will be strictly constant within and between participants. ERP: 1) neck cooling with an iced gel pad, 2) drinking a ∼ 6% CHO solution, 3) mouth-rinsing with a ∼10% CHO, ∼6 mg ・ kg -1 caffeine solution, 4) performing submaximal squats and 5) hyperventilating a hyperoxic mixture

ERP Intervention
PlaceboOTHER

The control intervention is applied in a randomized and counter-balanced order across visits 2-4 in each 3-min break in-between the six 30-s sprints, with one intervention per visit. The order and timing of the constituents of the interventions will be strictly constant within and between participants. 1\) neck "cooling" with room temperature gel pack, 2) drinking an artificially sweetened solution, 3) mouth-rinsing with artificially sweetened solution (containing no caffeine), 4) performing unloaded squat manoeuvres, 5) deep breaths with room air

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Healthy
  • Male
  • Age: 18-40 years
  • Body-Mass-Index (BMI): 18.5-24.9 kg・m-2
  • Trained individuals: max. Power output ≥ 4.0 Watts・kg-1
  • Non-smoking
  • Willingness to adhere to the study rules

You may not qualify if:

  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participants
  • Previous enrolment into the current study
  • Intake of medications affecting performance or the respiratory, cardiovascular or neuromuscular system
  • Acute or chronic illness affecting performance or the respiratory, cardiovascular or neuromuscular system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETH Zürich, Exercise Physiology Lab

Zurich, Canton of Zurich, 8057, Switzerland

Location

Study Officials

  • Christina M. Spengler, Prof.

    Christina M. Spengler, Prof. Study Principal Investigator Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded about the true nature of the placebo intervention
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Each participant will be tested on 4 different days with a control, a placebo and an interventional condition in random order.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 11, 2020

Study Start

September 10, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 2, 2021

Record last verified: 2020-10

Locations