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

NCT03419169 | Unknown FDA Device

• 1 other identifier: 16/YH/0066
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Anterior Cruciate Ligament Injury

Keywords

Patient; Rehabilitation; Ligament reconstruction; Surgery

Outcome Measures

Primary Outcomes (2)

• Change in ten repetition maximum strength

  Unilateral isotonic muscle strength, measured in kilograms.

  Throughout study completion, up to one year

• Change in isokinetic strength

  Unilateral peak torque at 60°/second, 150°/second, and 300°/second, measured in newton-metres.

  Throughout study completion, up to one year

Secondary Outcomes (13)

• Muscle thickness, measured in centimetres

  Throughout study completion, up to one year

• Pennation angle of muscle fibres, measured in degrees (°)

  Throughout study completion, up to one year

• Fascicle length, measured in centimetres

  Throughout study completion, up to one year

• International Knee Documentation Committee subjective knee form

  Throughout study completion, up to one year

• Knee Injury and Osteoarthritis Outcome Score

  Throughout study completion, up to one year

Study Arms (2)

Light load BFR resistance training

EXPERIMENTAL

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

Heavy load resistance training

ACTIVE COMPARATOR

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

Interventions

Light load BFR resistance training DEVICE

A novel training light load resistance training modality.

Light load BFR resistance training

Heavy load resistance training PROCEDURE

A common form of resistance training used for rehabilitation within the National Health Service.

Heavy load resistance training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Registered patient of University College London Hospitals
• Over 18 years of age
• Present with a unilateral ACL tear
• \. Scheduled for reconstructive surgery 6. Have the mental capacity to make informed decisions

You may not qualify if:

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

Sponsors & Collaborators

• University College London Hospitals: lead
• St. Mary's University, Twickenham: collaborator

Study Sites (2)

University College London Hospitals

London, NW1 2BU, United Kingdom

RECRUITING

St. Mary's University

London, TW14SX, United Kingdom

RECRUITING

Related Publications (3)

• Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.

  PMID: 28259850 BACKGROUND

• Cavanaugh JT, Powers M. ACL Rehabilitation Progression: Where Are We Now? Curr Rev Musculoskelet Med. 2017 Sep;10(3):289-296. doi: 10.1007/s12178-017-9426-3.

  PMID: 28791612 BACKGROUND

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

  PMID: 24141714 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Stephen Patterson, PhD

  St. Mary's University, Twickenham

  PRINCIPAL INVESTIGATOR

• Fares Haddad

  University College London Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luke Hughes, MSc

CONTACT

luke.hughes@stmarys.ac.uk

Bruce Paton, PhD

CONTACT

bruce.paton@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 1, 2018
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 9, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)