Clinical trial NCT03419169: Light Load Blood Flow Restriction Training in Anterior Cruciate Ligament Reconstruction Patient Rehabilitation
Official title: Light Load Blood Flow Restriction Versus Heavy Load Resistance Training in the Post-operative Rehabilitation of Anterior Cruciate Ligament Reconstruction Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Keywords: Patient
Rehabilitation
Ligament reconstruction
Surgery
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: St. Mary's University, Twickenham
First posted: 2018-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Detailed description: Light load BFR training is an effective rehabilitation tool for improving strength in individuals suffering clinical muscle weakness (Hughes et al. 2017). This is a single blinded, randomised controlled clinical trial, comprised of a two (group) by five (time) between-subjects repeated measures design. This study will place within the NHS at University College London Hospital (UCLH). Eligible patients from the orthopaedic department theatre lists of four orthopaedic surgeons at UCLH will be contacted prior to surgery via phone call and sent the patient information sheet and schematic outlining the study. Patient clinical history and documentation will be screened initially by the principle researcher followed by screening over the phone upon contact. Patients who are willing to participate will then be invited to the hospital for a full health screening appointment following provision of written informed consent, in compliance with the Declaration of Helsinki, 7th version, October 2013.

Baseline assessment of all outcome measures will take place at the pre-surgery screening appointment. Patient will then undergo their surgery. Following two weeks of recovery, repeat assessment of outcome measures will take place once patients achieve the following criteria for beginning strength rehabilitation, as developed by Cavanaugh and Powers (2017): 1) Able to unilaterally weight bear without pain; 2) Able to perform a single leg raise without quadriceps lag; 3) Have a range of motion (ROM) of 0-90 degrees; and 4) Have minimal swelling. Patients will then be allocated to one f the two training intervention groups and undergo eight weeks of twice weekly unilateral leg press training. Training sessions include five minutes of light cycling at a free cadence on a stationary ergometer for both groups, followed by the respective leg press protocols. Repeat assessment of outcome measures will take place mid-training (between weeks four and five) and post-training. Ratings of perceived pain and exertion, blood pressure and any adverse events will be recorded at all training and assessment sessions. All outcomes will also be assessed at 3 and 6 month follow up assessments. Pain will also be assessed 24 hours after every training session. During the study, all participants will see their assigned physiotherapist fortnightly (as per standard hospital protocol) and receive individualised programmes focussing on improving ROM, balance and minimising swelling.

BFR will be achieved using the Delfi Easy-fit variable contour tourniquet cuff (11.5 cm x 86 cm x 5 mm) connected to the automatic personalised tourniquet system (PTS) device (Delfi Medical, Vancouver, British Columbia, Canada). The Delfi PTS for BFR is equipped with the capability of automatically measuring limb occlusive pressure (LOP) and calculating the personalised tourniquet pressure, comprised of a dual-purpose personalised tourniquet cuff and a personalised tourniquet instrument containing LOP calculation sensors and software. The PTS system connected to the tourniquet cuff increases the cuff pressure in stepwise increments, analyses the pneumatic pressure pulsations in the cuff bladder by the arterial pressure pulsations at each cuff pressure increment, and uses these characteristics to determine LOP.

The primary outcome measure of muscle strength was used for calculating the required sample size. Based on previous data regarding muscle strength increases in light load BFR resistance training studies in clinical populations, to achieve a power of 80% at an alpha level 0.05, a total of 28 participants is required to detect a meaningful effect. Based on hospital record of rehabilitation programmes, a drop-out rate of 10% can be expected during the course of rehabilitation programmes. Therefore, a total of 30 participants will be recruited.

All data will be stored on the NHS password protected server at UCLH as per hospital and NHS ethical requirements. Data from drop-outs will not be included in the final analysis. Descriptive statistics (mean ± standard deviation) will be used to summarise adherence rates, exercise session attendance, training volume any adverse events. All statistical analysis will be performed with IBM Statistical Package for the Social Sciences (SPSS) Version 22.0 (IBM Corp, Chicago Illinois, United States of America). All data will be presented as means ± standard deviation with 95% confidence intervals unless stated otherwise. Normal distribution of data will be assessed using Shapiro-Wilks test (p\>0.05). Ten repetition maximum strength, muscle size measures, self-reported physical function measures and functional performance will each be analysed using 2 x 5 (rehabilitation intervention x TP) repeated measures analysis of variance (ANOVA)s. Isokinetic strength and knee ligament laxity will be assessed using 2 x 3 (rehabilitation intervention x TP) repeated measures ANOVAs. Perceptual responses for ratings of perceived exertion and pain will be assessed using 2 x 16 (rehabilitation intervention x exercise session) repeated measures ANOVAs. For any statistically significant two-way interaction, one-way repeated measures ANOVAs with Bonferroni correction will be used to examine simple main effects. Non-normally distributed data will be analysed using the non-parametric Friedman test. Alpha significance will be set a priori p\<0.05.

Eligibility 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

Primary outcomes:
measure: Change in ten repetition maximum strength
timeFrame: Throughout study completion, up to one year
measure: Change in isokinetic strength
timeFrame: Throughout study completion, up to one year
Secondary outcomes:
measure: Muscle thickness, measured in centimetres
timeFrame: Throughout study completion, up to one year
measure: Pennation angle of muscle fibres, measured in degrees (°)
timeFrame: Throughout study completion, up to one year
measure: Fascicle length, measured in centimetres
timeFrame: Throughout study completion, up to one year
measure: International Knee Documentation Committee subjective knee form
timeFrame: Throughout study completion, up to one year
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Throughout study completion, up to one year
measure: Lower Extremity Functional Scale to assess performance in functional tasks
timeFrame: Throughout study completion, up to one year
measure: Lysholm knee scoring scale to assess performance in functional tasks.
timeFrame: Throughout study completion, up to one year
measure: Tegner activity scale for grading patient activity level
timeFrame: Throughout study completion, up to one year
measure: Physical functional performance
timeFrame: Throughout study completion, up to one year
measure: Knee ligament laxity
timeFrame: Throughout study completion, up to one year
measure: Borg's (1998) rating of perceived pain scale for assessing pain during exercise.
timeFrame: 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.
measure: Borg's (1998) rating of perceived exertion scale for assessing exertion during exercise.
timeFrame: During all testing sessions and between sets during all training sessions over the eight week training period.
measure: Blood pressure
timeFrame: Pre-exercise and 5 minutes post-exercise for all training sessions over the eight week training period
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: St. Mary's University
Study officials:
affiliation: St. Mary's University, Twickenham
name: Stephen Patterson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London Hospital
name: Fares Haddad
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.