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Light Load Blood Flow Restriction Training in Anterior Cruciate Ligament Reconstruction Patient Rehabilitation

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ClinicalTrials.gov Identifier: NCT03419169
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
St. Mary's University
Information provided by (Responsible Party):
Luke Hughes, University College London Hospitals

Brief Summary:
This study is examining the post-operative rehabilitation of anterior cruciate ligament (ACL) reconstruction patients within the National Health Service (NHS). It will compare the effectiveness of two resistance training protocols, light load blood flow restriction (BFR) training and heavy load training, on improving multiple aspects important to the rehabilitation process in this patient demographic, whilst also examining the feasibility of this novel training modality. It is hypothesised that light load BFR training will be equally effective as heavy load training, but more tolerable for patients.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Device: Light load BFR resistance training Procedure: Heavy load resistance training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be assigned to one of two groups: 1) Light load BFR resistance training; or 2) Heavy load resistance training. An independent member of the research team will carry out block randomisation using opaque envelopes containing slips of paper. Each envelope will contain four slips (Two x BFR group and two x heavy load group), thus patients will be randomised in groups of four.
Masking: Single (Outcomes Assessor)
Masking Description: The assessor of all outcome measures will be masked as to which group patients have been assigned. Patient information will be coded using a numerical system by and independent member of the research team during the course of the study and data analysis.
Primary Purpose: Treatment
Official Title: Light Load Blood Flow Restriction Versus Heavy Load Resistance Training in the Post-operative Rehabilitation of Anterior Cruciate Ligament Reconstruction Patients
Actual Study Start Date : February 1, 2016
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Light load BFR resistance training
This arm of the clinical trial will involve eight weeks of twice weekly light load resistance training with BFR. Patients in this arm will complete four sets (30, 15, 15 and 15 repetitions, respectively) of unilateral leg press exercise at 30% of predicted one repetition maximum. BFR will be applied at 80% of total limb arterial occlusive pressure. Both legs will be trained, with the affected limb trained first and the unaffected limb matched for volume at a relative percentage of one repetition maximum. Both legs will be trained with BFR.
Device: Light load BFR resistance training
A novel training light load resistance training modality.

Active Comparator: Heavy load resistance training
This arm of the clinical trial will involve eight weeks of twice weekly heavy load resistance training. Patients in this arm will complete three sets of ten repetitions of unilateral leg press exercise at 70% of predicted one repetition maximum. Both legs will be trained, with the affected limb trained first and the unaffected limb matched for volume at a relative percentage of one repetition maximum.
Procedure: Heavy load resistance training
A common form of resistance training used for rehabilitation within the National Health Service.




Primary Outcome Measures :
  1. Change in ten repetition maximum strength [ Time Frame: Throughout study completion, up to one year ]
    Unilateral isotonic muscle strength, measured in kilograms.

  2. Change in isokinetic strength [ Time Frame: Throughout study completion, up to one year ]
    Unilateral peak torque at 60°/second, 150°/second, and 300°/second, measured in newton-metres.


Secondary Outcome Measures :
  1. Muscle thickness, measured in centimetres [ Time Frame: Throughout study completion, up to one year ]
    Thickness of the vastus lateralis muscle

  2. Pennation angle of muscle fibres, measured in degrees (°) [ Time Frame: Throughout study completion, up to one year ]
    Angle of fibres in the vastus lateralis muscle

  3. Fascicle length, measured in centimetres [ Time Frame: Throughout study completion, up to one year ]
    Length of fascicles in the vastus lateralis muscle

  4. International Knee Documentation Committee subjective knee form [ Time Frame: Throughout study completion, up to one year ]
    Used to assess symptoms and function in daily living activities

  5. Knee Injury and Osteoarthritis Outcome Score [ Time Frame: Throughout study completion, up to one year ]
    Used to assess participant's opinion of their knee and associated problems

  6. Lower Extremity Functional Scale to assess performance in functional tasks [ Time Frame: Throughout study completion, up to one year ]
    Used to assess patient's ability to perform everyday tasks, including walking and stair climbing. It contains 20 questions each with a scoring scale of 0-4 and a test-retest reliability of 0.88 to 0.94. The scores of each question will be summed to get a total score out of 80, with lower scores indicating greater functional disability. The minimal detectable change will be set at 9 scale points.

  7. Lysholm knee scoring scale to assess performance in functional tasks. [ Time Frame: Throughout study completion, up to one year ]
    Used to evaluate outcomes of the surgery. It comprises 8 items, including: limp, support, locking, instability, pain, swelling, stair climbing and squatting. Each item is scored differently - scores will be summed to give a total out of 0-100 (where 100 indicates no symptoms or disability) and categorised as excellent (95-100), good (84-94), fair (65-83), and poor (≤64).

  8. Tegner activity scale for grading patient activity level [ Time Frame: Throughout study completion, up to one year ]
    Used to grade participant activity level. The scale ranges from 0-10, with 0 representing sick leave or disability pension because of knee problems, and 10 corresponding to participation in national and international elite competitive sports. Minimum clinically importance difference will be set at 1.

  9. Physical functional performance [ Time Frame: Throughout study completion, up to one year ]
    Star-excursion balance test of dynamic knee joint stability, measured in centimetres

  10. Knee ligament laxity [ Time Frame: Throughout study completion, up to one year ]
    Laxity of the knee, measured in pounds.

  11. Borg's (1998) rating of perceived pain scale for assessing pain during exercise. [ Time Frame: During all testing sessions, between sets during all training sessions over the eight week training period, and 24 hours post-training for every training session. ]
    Used to measured the patient's perceived pain during exercise. The scale ranges from 0 to 10. Patients will be informed that a rating of 0 means they felt no pain, and 10 is their reference point which represents their previous worst felt pain/discomfort, and that they can give a score of 11 if the pain is worse than any they have ever felt before.

  12. Borg's (1998) rating of perceived exertion scale for assessing exertion during exercise. [ Time Frame: During all testing sessions and between sets during all training sessions over the eight week training period. ]
    Used to measured the patient's perceived exertion during exercise. The scale ranges from 6-20. It will be explained to patients that a rating of 6 meant they felt no exertion, and 20 meant they were giving maximal effort and could not exert themselves any further.

  13. Blood pressure [ Time Frame: Pre-exercise and 5 minutes post-exercise for all training sessions over the eight week training period ]
    Systolic and diastolic blood pressure, measured in millimetres of mercury using an automatic device.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Registered patient of University College London Hospitals
  2. Over 18 years of age
  3. Present with a unilateral ACL tear

5. Scheduled for reconstructive surgery 6. Have the mental capacity to make informed decisions

Exclusion Criteria:

  1. Multiple ligamentous ruptures or trauma
  2. Rheumatoid arthritis or significant comorbidities
  3. Presence or history of cardiovascular, pulmonary, respiratory of neurological disease
  4. Intraarticular injections into the knee in the preceding 6 months
  5. History of deep vein thrombosis or vascular pathology in any lower limb
  6. Current use of anticoagulant medications or other medications that may affect blood flow or fluid exchange
  7. Hypertension (>140/80 mmHg)
  8. Inability to follow instructions for rehabilitation classes (e.g. advanced dementia)
  9. Scheduling for post-operative leg bracing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419169


Contacts
Contact: Luke Hughes, MSc luke.hughes@stmarys.ac.uk
Contact: Bruce Paton, PhD bruce.paton@nhs.net

Locations
United Kingdom
University College London Hospitals Recruiting
London, United Kingdom, NW1 2BU
Contact: Luke Hughes, MSc       luke.hughes@nhs.net   
Contact: Bruce Paton, PhD       bruce.paton@nhs.net   
Principal Investigator: Fares Haddad         
St. Mary's University Recruiting
London, United Kingdom, TW14SX
Contact: Luke Hughes, MSc       luke.hughes@stmarys.ac.uk   
Contact: Stephen Patterson, PhD       stephen.patterson@stmarys.ac.uk   
Principal Investigator: Stephen Patterson, PhD         
Sponsors and Collaborators
University College London Hospitals
St. Mary's University
Investigators
Principal Investigator: Stephen Patterson, PhD St. Mary's University
Principal Investigator: Fares Haddad University College London Hospital

Publications:
Responsible Party: Luke Hughes, Principal Investigator, University College London Hospitals
ClinicalTrials.gov Identifier: NCT03419169     History of Changes
Other Study ID Numbers: 16/YH/0066
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Luke Hughes, University College London Hospitals:
Patient
Rehabilitation
Ligament reconstruction
Surgery

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries