The Effect of Blood Flow Restriction Training on Hamstring Elasticity After Injury

NCT04246515 | Unknown

• 1 other identifier: B670201940629
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of Blood Flow Restriction Training on the elasticity of the hamstring muscle after an acute injury. Therefore a group of football players with a recent hamstring strain injury (HSI) will be recruited and randomly assigned in one of the three following groups: Experimental group: Classic rehabilitation + Blood Flow Restriction Training Sham group: Classic rehabilitation + sham Blood Flow Restriction Training Control group: Classic rehabilitation The study procedure will be as followed:

1. 1.HSI (onset) -\> recruitment via football clubs, physiotherapy practices, leaflets,…
2. 2.MRI scan (day 0-4) -\> injury location, grade and extend (The British Athletics Medical Team Classification)
3. 3.Shear Wave Elastography (SWE) measurement (day 0-4) of the injured site and the exact same location at the contralateral leg.
4. 4.Rehabilitation in one of the three groups + Testing
5. 5.Return to play (RTP)
6. 6.Follow-up

Conditions

Hamstring Injury

Keywords

Hamstring injury; Shear Wave Elastography; Blood Flow Restriction

Outcome Measures

Primary Outcomes (2)

• Change of elasticity

  Change of the Shear Modulus of the injured site of the hamstring from onset untill 12 weeks.

  From date of randomization until 12 weeks.

• Time to return to play

  Time between injury onset and moment of return to play. Return to play is the moment when the athlete is cleared for sport participation by the medical staff based on 4 standardized criteria: 1. No pain on palpation 2. Pain free full Range of Motion (ROM) 3. Max (ecc) strength difference 10 % 4. Symptom-free completion of rehab program and repeated maximal (30m) sprinting.

  From injury onset until moment of return to play, up to an average of 3 weeks.

Secondary Outcomes (3)

• Pain on palpation and average pain at each therapy session

  Weekly from fist therapy session until moment of return to play, up to an average of 3 weeks.

• Eccentric strength

  Weekly from fist therapy session until moment of return to play, up to an average of 3 weeks.

• Flexibility

  Weekly from fist therapy session until moment of return to play, up to an average of 3 weeks.

Study Arms (3)

Blood Flow Restriction Training

EXPERIMENTAL

As from week 2 in the rehabilitation proces, this experimental group will receive exercises in combination with blood flow restriction. While occluding the vascular flow of the limb (startpoint = above the injury site), participants will perform 3 exercises: wall squat, leg press and bridge (3 sets of 30 repetitions). These blood flow restricted exercises are always on top of the classic rehabilitation.

Device: Blood Flow Restriction Training

Sham Blood Flow Restriction Training

SHAM COMPARATOR

The same description as the experimental arm is applicable here. However, The Blood Flow restriction material will be attached to the injured limb without occluding the vascular blood flow.

Device: Sham Blood Flow Restriction Training

Classic rehabilitation

ACTIVE COMPARATOR

This group will undergo the classic rehabilitation program.

Other: Classic rehabilitation

Interventions

Blood Flow Restriction Training DEVICE

Vascular occlusion of the injured limb.

Also known as: Vascular occlusion Training

Blood Flow Restriction Training

Sham Blood Flow Restriction Training DEVICE

Blood Flow Restriction material will be attached to the limb without vascular occlusion.

Sham Blood Flow Restriction Training

Classic rehabilitation OTHER

Classic rehabilitation protocol after a hamstring injury consisiting out of stretching, strength, core stability,...

Classic rehabilitation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Only men will be included as this gender population is the most susceptible for the development of hamstring injuries.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Acute hamstring strain injury
• Male
• Adult (18+) between 18 and 35 years old

You may not qualify if:

• History of hamstring injuries
• Recent severe trauma or surgery in the lower extremity
• Any contra-indication for occluding vascular flow (such as hypertension, risk factors for and/or history of cardiovascular pathologies or thromboembolism, surgery, fractures, severe obesity,…)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Department of rehabilitation sciences

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Erik Witvrouw, Prof. dr.

  Department of Rehabilitation Sciences, Ghent University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dries Pieters

CONTACT

+32 9 332 6917; dries.pieters@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 29, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)