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

Primary Purpose

Hamstring Injury

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood Flow Restriction Training
Sham Blood Flow Restriction Training
Classic rehabilitation
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hamstring Injury focused on measuring Hamstring injury, Shear Wave Elastography, Blood Flow Restriction

Eligibility Criteria

18 Years - 35 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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,…)

Sites / Locations

  • Department of rehabilitation sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Blood Flow Restriction Training

Sham Blood Flow Restriction Training

Classic rehabilitation

Arm Description

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.

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.

This group will undergo the classic rehabilitation program.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain on palpation and average pain at each therapy session
Pain Visual Analogue Scale (VAS). The pain VAS is a unidimensional measure of pain intensity with the use of a Likert scale from 0 to 10, with 0 = no pain and 10 = worst possible pain.
Eccentric strength
Eccentric strength of the injured hamstring muscle
Flexibility
Flexibility of the injured hamstring muscle using the Maximal Hip Flexion Active Knee Extension Test (MHFAKE)

Full Information

First Posted
January 21, 2020
Last Updated
October 2, 2023
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04246515
Brief Title
The Effect of Blood Flow Restriction Training on Hamstring Elasticity After Injury
Official Title
The Effect of Blood Flow Restriction Training on the Mechanical Properties of Hamstring Injuries: A Prospective, Randomised Clinical Trial Using Supersonic Shear Wave Elastography
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: HSI (onset) -> recruitment via football clubs, physiotherapy practices, leaflets,… MRI scan (day 0-4) -> injury location, grade and extend (The British Athletics Medical Team Classification) Shear Wave Elastography (SWE) measurement (day 0-4) of the injured site and the exact same location at the contralateral leg. Rehabilitation in one of the three groups + Testing At the first therapy session a standardized initial assessment sheet will be filled in comprising of all the necessary information regarding patient information and history (recent hamstring injury and past injuries) . Furthermore, a weekly assessment of the strongest predictors of rehabilitation duration will be conducted. Between day 12 and 16 a second shear wave elastographic measurement will be performed. Return to play (RTP) The RTP decision will be made by the head physician and the attending physiotherapist. The decision will be based on clearly predefined criteria. At moment of RTP a third shear wave elastographic measurement will be performed. Follow-up The football players will be contacted regularly by phone to inquire about possible re-injuries, this for a period of 6 months after injury onset. At week 12 after injury onset, a fourth and last shear wave elastographic measurement will be performed. The evolution of the hamstring elasticity and other outcome measures will be compared between groups and also within groups between the injured leg and the healthy contralateral leg.
Detailed Description
In this study, 90 participants with an acute hamstring strain injury will participate. Age restrictions will be delimited between 18 and 35 years old to rule out age-related confounding factors. Potential participants will be excluded from this study if they had a history of hamstring injuries, or a recent severe trauma or surgery in the lower extremity. A hamstring injury is defined as a football-related injury in the posterior thigh muscle region, preventing a player from participating in training or competition for at least 1 week. In addition, 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,…) will entail an immediate exclusion from the study. Within 4 days after the onset of a suspected HSI the participant will undergo a magnetic resonance (MR) scan in order to acquire more insight in the severity, location and extend of the injury. The British Athletics Medical Team Classification will be used to classify HSI on the basis of grade (1: small tear, 2: moderate tear, 3: extensive tear or 4: complete tear) and injury site (a: myofascial, b: MTJ or c: tendon). [Pollock et al.2014] Each participant will be assigned an unique number and subsequently randomly assigned to either the control, experimental treatment or sham group by using an online research randomizer (http://www.randomizer.org) which is already used in previous literature [van der Horst et al. 2015]. This will result in a total of 30 participants per treatment group. The experimental group will perform, on top of a classic rehabilitation protocol, exercises while occluding the vascular blood flow. The use of low-intensity exercises with vascular blood flow restriction (BFR) has been found, in previous studies, to induce the same hypertrophic muscle adaptations as high-intensity exercises without BFR. The combination of increased metabolic stress, due to an Ischemic and hypoxic muscular environment, and exercise induced mechanical tension is suggested to be responsible for this effect. [Hughes et al. 2017] The patients in the sham BFR group will receive the same protocol as the experimental group with the exception of not inflating the Blood flow restriction cuff, causing no real vascular occlusion. Furthermore, the intervention in the control group will consist out of a classic rehabilitation program suitable for treating a hamstring injury. Shortly after the MR scan, still in the first week after injury onset, a shear wave elastography measurement of the injured site and at exact same location at non-injured site will be performed. Appendicular to the first, three more elastographic measurements will be performed at fixed moments in time: between day 12 and 16, at moment of return to play (RTP) and at week 12 after injury onset. All the participants will undergo a standardized rehabilitation protocol in one of the three groups until the medical team cleared the patient for returning to sport participation, based on clearly defined and standardised criteria. Tests and questionnaires for evaluation of hamstring strength, flexibility, pain and functionality will be conducted at three major moments in the rehabilitation process: within the first therapy session, weekly during the complete rehabilitation process and at moment of return to play. After RTP, athletes will be contacted regularly, until six months after injury onset, to determine the number of re-injuries. A questionnaire concerning demographic and anthropometric data, sport activities and injury history will be completed by the participants, prior to the testing protocol, as these factors will be additionally investigated for their possible influence on the primary outcome measures. The aim of the study is to investigate the effect of vascular occlusion (Blood Flow Restriction Training), within the rehabilitation program, on the healing proces (outcome measures predictive for the duration of the rehabilitation: average pain at each therapy session, eccentric mid and outer range strength, total painful palpation length, maximal hip flexion active knee extension test) and especially on the elasticity of the injured hamstring muscle tissue (measured with shear wave elastography).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hamstring Injury
Keywords
Hamstring injury, Shear Wave Elastography, Blood Flow Restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood Flow Restriction Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Blood Flow Restriction Training
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Classic rehabilitation
Arm Type
Active Comparator
Arm Description
This group will undergo the classic rehabilitation program.
Intervention Type
Device
Intervention Name(s)
Blood Flow Restriction Training
Other Intervention Name(s)
Vascular occlusion Training
Intervention Description
Vascular occlusion of the injured limb.
Intervention Type
Device
Intervention Name(s)
Sham Blood Flow Restriction Training
Intervention Description
Blood Flow Restriction material will be attached to the limb without vascular occlusion.
Intervention Type
Other
Intervention Name(s)
Classic rehabilitation
Intervention Description
Classic rehabilitation protocol after a hamstring injury consisiting out of stretching, strength, core stability,...
Primary Outcome Measure Information:
Title
Change of elasticity
Description
Change of the Shear Modulus of the injured site of the hamstring from onset untill 12 weeks.
Time Frame
From date of randomization until 12 weeks.
Title
Time to return to play
Description
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.
Time Frame
From injury onset until moment of return to play, up to an average of 3 weeks.
Secondary Outcome Measure Information:
Title
Pain on palpation and average pain at each therapy session
Description
Pain Visual Analogue Scale (VAS). The pain VAS is a unidimensional measure of pain intensity with the use of a Likert scale from 0 to 10, with 0 = no pain and 10 = worst possible pain.
Time Frame
Weekly from fist therapy session until moment of return to play, up to an average of 3 weeks.
Title
Eccentric strength
Description
Eccentric strength of the injured hamstring muscle
Time Frame
Weekly from fist therapy session until moment of return to play, up to an average of 3 weeks.
Title
Flexibility
Description
Flexibility of the injured hamstring muscle using the Maximal Hip Flexion Active Knee Extension Test (MHFAKE)
Time Frame
Weekly from fist therapy session until moment of return to play, up to an average of 3 weeks.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only men will be included as this gender population is the most susceptible for the development of hamstring injuries.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute hamstring strain injury Male Adult (18+) between 18 and 35 years old Exclusion Criteria: 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,…)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dries Pieters
Phone
+32 9 332 6917
Email
dries.pieters@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Witvrouw, Prof. dr.
Organizational Affiliation
Department of Rehabilitation Sciences, Ghent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of rehabilitation sciences
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dries Pieters

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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