NCT04531891

Brief Summary

The purpose of this study is to identify an exercise-induced fatigue protocol to mimic central and peripheral acute fatigue effects associated with participation in vigorous dynamic sports activities and to understand the expected central (cardiovascular) and peripheral (muscular) impact of this protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

September 7, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2021

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

August 13, 2020

Last Update Submit

November 19, 2021

Conditions

Outcome Measures

Primary Outcomes (8)

  • Heart rate

    Heart rate, expressed in beats per minute

    This parameters will be continuously monitored 10 minutes before the start of the fatigue protocol until 30 minutes after completion of the protocol

  • Isokinetic dynamometry

    Isokinetic dynamometry of the quadriceps muscle

    This parameter will be monitored 10 minutes before the start of the fatigue protocol

  • Isokinetic dynamometry

    Isokinetic dynamometry of the quadriceps muscle

    This parameter will be monitored immediately after completion of the protocol

  • Isokinetic dynamometry

    Isokinetic dynamometry of the quadriceps muscle

    This parameter will be monitored 15 minutes after completion of the protocol

  • Isokinetic dynamometry

    Isokinetic dynamometry of the quadriceps muscle

    This parameter will be monitored 30 minutes after completion of the protocol

  • Blood lactate level

    Blood lactate level, expressed in millimol per liter

    This parameters will be monitored 10 minutes before the start of the fatigue protocol

  • Blood lactate level

    Blood lactate level, expressed in millimol per liter

    This parameters will be monitored 10 minutes after completion of the protocol

  • BORG

    BORG-score, indicating the rate of perceived exertion for legs and breathlessness

    This parameters will be continuously monitored 10 minutes before the start of the fatigue protocol until 30 minutes after completion of the protocol

Secondary Outcomes (1)

  • Circuit time

    Time will be recorded immediately after completion of the fatigue protocol

Study Arms (2)

All-out, high-intensity, intermittent exercise protocol

EXPERIMENTAL
Other: Fatigue protocol

5 min, high-intensity, intermittent exercise protocol

EXPERIMENTAL
Other: Fatigue protocol

Interventions

During the fatigue protocol, participants will sprint forward 5 m, cut at a 90° angle, sprint forward another 5 m, and backpedal 5 m. This activity will be repeated 4 times before participants will complete a series of hurdle activities. First, they will perform 2-legged jumps over 5 hurdles that are 30 cm high, turn, and repeat the jumps. Second, they will perform side-stepping exercises over the 5 hurdles. Third, they will complete four 5-m lateral shuffles.

5 min, high-intensity, intermittent exercise protocolAll-out, high-intensity, intermittent exercise protocol

Eligibility Criteria

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

You may qualify if:

  • Men
  • ≥ 18 years
  • Volley- and basketball, non-elite
  • ≥ 3 times per week sports participation
  • No acute or overuse low back/lower extremity injuries in the past 6 months

You may not qualify if:

  • Women
  • \<18 years
  • \>45 years
  • other sports than volley- and basketball
  • elite players
  • \<3 times per week sports participation
  • acute or overuse low back/lower extremity injuries in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vakgroep Revalidatiewetenschappen

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: Each participant will randomly be assigned to two different fatigue protocols, on separate days. The first protocol is a high-intensity, intermittent exercise protocol and will be performed until complete exhaustion. The second protocol is a time-based variant of the previous protocol and will be performed during 5 minutes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 31, 2020

Study Start

September 7, 2020

Primary Completion

June 30, 2021

Study Completion

November 19, 2021

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations