NCT05153980

Brief Summary

Sixty athletes will be randomized in two groups; (1) an experimental group and (2) a control group. Both groups will undergo the following procedure: Moment 1:

  1. 1.Baseline testing: countermovement jump, 25m sprint and strength assessment of the Hamstrings and Quadriceps muscle.
  2. 2.Short warm-up (approximately 4 minutes), which will be completed with blood flow restriction cuffs (experimental group) or without (control group)
  3. 3.Post testing: same tests as performed in baseline.
  4. 4.Baseline testing: stiffness measurements of the Biceps Femoris Long Head via Shear Wave Elastography.
  5. 5.Short warm-up (approximately 4 minutes), which will be completed with blood flow restriction cuffs (experimental group) or without (control group)
  6. 6.Post testing: same tests as performed in baseline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable healthy

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

November 2, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

November 15, 2021

Last Update Submit

December 4, 2023

Conditions

Healthy

Keywords

Shear Wave ElastographyBlood Flow RestrictionWarm-upPerformance

Outcome Measures

Primary Outcomes (4)

  • Change in muscle stiffness

    The stiffness of the Biceps Femoris Long Head of the dominant leg will be assessed via a Shear Wave Elastography Device (Mach 30, SuperSonic Imagine), before and immediately after the warm-up routine. The muscle stiffness will be expressed in Kilopascals (kPa).

    (1) Before the warm-up routine, (2) immediately after the warm-up routine, (3) 5 minutes after the warm-up routine, and (4) 10 minutes after the warm-up routine

  • Change in jump height

    The jump height will be assessed during 5 consecutive countermovement jumps. This will be assessed with an OptoJump device. The highest jump will be taken into account. The jump height will be expressed in cm.

    (1) Before the warm-up routine and (2) immediately after the warm-up routine

  • Change in muscle strength

    Muscle strength of the Hamstrings and Quadriceps muscles. Measured via a Hand Held Dynamometer. Strength will be expressed in Newton (N).

    (1) Before the warm-up routine and (2) immediately after the warm-up routine

  • Change in sprinting speed

    Sprinting speed will be assessed at 5m, 10m and 25m. This via the use of timing gates. This outcome measure will be expressed in seconds (s).

    (1) Before the warm-up routine and (2) immediately after the warm-up routine

Secondary Outcomes (2)

  • level of readiness

    Immediately after the warm-up

  • Change in heart rate

    (1) Right before the warm up, (2) after one minute, (3) after two minutes, (4) after 3 minutes, (5) at the end of the warm up

Study Arms (2)

Blood Flow Restriction

EXPERIMENTAL

Incorporation of Blood Flow Restriction within the warm-up routine.

Device: Warm-up + Blood Flow Restriction cuff (smart-cuff pro device, acting as pressurized tourniquet)

Control Group

ACTIVE COMPARATOR

Warm-up routine without any special intervention (no Blood Flow Restriction).

Other: Warm-up

Interventions

Warm-up + Blood Flow Restriction cuff (smart-cuff pro device, acting as pressurized tourniquet)DEVICE

Blood Flow Restriction

Also known as: Kaatsu, partial vascular occlusion
Blood Flow Restriction
Warm-upOTHER

Warm-up without any special intervention (no Blood Flow Restriction)

Control Group

Eligibility Criteria

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

You may qualify if:

  • Free of pain at the moment of testing
  • Adult (18+)
  • Athletes (competitive team sport)

You may not qualify if:

  • History of a hamstring strain injury
  • History of cardiovascular problems
  • Recent (\<1 year) trauma or surgery of the lower extremity
  • Reduced functioning or pain in the lower extremity.
  • Not being able to perform physical activities, for whatever (medical) reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Warm-Up Exercise

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Erik Witvrouw

    Departement of Rehabilitation Sciences, Ghent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 10, 2021

Study Start

November 2, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations

BE(1)