Is Low-load Resistance Training With Blood Flow Restriction More Effective Than Traditional Rehabilitation of Military Personnel With Lower Limb Injuries

Official title

The Effects of Different Blood Flow Restriction Training Methodologies During the Rehabilitation of Military Personnel With Lower Limb Musculoskeletal Injuries Primarily Limited by Pain: a 2 Part Randomised Controlled Trial (Phase Two)

Overview

Pain can be one of the primary limiting factors to progress following musculoskeletal injury and may be caused by trauma or degenerative changes. There are few exercise rehabilitation interventions able to relieve pain, thereby reducing the number of military personnel fit for operations. Low load blood flow restriction (BFR) exercise has been shown to elicit an analgesic response and promote beneficial physiological changes in a variety of clinical populations. This two phase study, aims to: * Determine the most effective and feasible BFR resistance exercise protocol for reducing pain in UK military patients. * Determine the efficacy of an optimal BFR exercise protocol for reducing pain and improving rehabilitation outcomes in UK military patients. * Identify key physiological mechanisms underpinning any beneficial effect of BFR exercise on pain. Consequently, results from this study will have direct clinical application and will aid best practice guidelines for the management of pain across Defence Rehabilitation by influencing the future rehabilitation paradigm. The investigators believe the results and impact will be far reaching, providing invaluable insight and knowledge to the clinical and scientific community to not only those embedded within Defence Rehabilitaion, but also those working in civilian sector organisations and professional sport also.

Interventions

• Device BFR
  The intervention involves placing a pneumatic tourniquet system over the proximal thigh. The cuff is inflated to either 80% or 40% of limb occlusion pressure during lower limb strengthening exercises, as determined by Phase One (2318/MODREC/24a). These exercises include leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum in Week 1, 25% in Week 2 and 30% in Week 3.
• Other control group
  Standard residential rehabilitation consists of; (1) exercise-based therapy delivered in group settings and individually to address a variety of physical components relating to their pathology (e.g., balance and co-ordination, cardiovascular endurance, mobility and flexibility, motor control and dynamic stability, and muscular strength), (2) patient education sessions (e.g., activity modification, behavioural change, and focusing on pain management), and (3) one-on-one support sessions (e.g., di

Primary outcome measures

• Brief Pain Inventory [Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)]

Secondary outcome measures (12)

• 5-RM Testing [Time frame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)]
• Numerical Pain Rating Scale [Time frame: T2, Daily (before, immediately-post, and 1 hour-post each BFR session; days 1-5, 6-10 and 11-15).]
• Sessional Rate of Perceived Exertion [Time frame: T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).]
• Training Load [Time frame: T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).]
• Copenhagen Hip and Groin Score [Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)]
• Lower Extremity Function Scale [Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)]
• Daily Morning Wellbeing [Time frame: T2, Daily (before BFR session; days 1-5, 6-10 and 11-15).]
• Isometric Mid-Thigh Pull [Time frame: T0, Pre-Admission (Day 0); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15)]
• Pressure Pain Threshold Testing [Time frame: T0, Pre-Admission (Day 0); T1, Course Admission (Day 1); T2, Daily (Day 1-5, Day 6-10, Day 11-15); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15)]
• Foot and Ankle Disability Index [Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)]
• Knee Injury and Osteoarthritis Outcome Score [Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)]
• Leeds Assessment of Neuropathic Symptoms and Signs [Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)]

Eligibility criteria

Inclusion criteria

• Serving UK military personnel,
• Aged 18-55,
• Has unilateral lower limb injury whereby pain is the primary limiting factor hindering progression, as diagnosed by relevant consultant and team,
• Reduced occupational employability and function,
• Scheduled to attend DMRC Stanford Hall for 3 week residential rehabilitation course.

MSK-Specific Exclusion Criteria

• Any medical contraindication related to BFR\*
• Non-musculoskeletal or serious pathological condition (i.e. Inflammatory arthropathy, infection or tumour)
• Spinal or referred pain from non-local pain source
• Any pre-diagnosed physical impairment or co-morbidities (including cardio-vascular disease) precluding the safe participation in the rehabilitation programme and/or assessment procedures
• Corticosteroid or analgesic injection intervention to the affected area within the previous 7 days
• Currently pregnant, or have not yet completed a return to work assessment following the birth of your child.

\*Medical-Related Exclusion Criteria

• History of cardiovascular disease (hypertension, peripheral vascular disease, thrombosis/embolism, ischaemic heart disease, myocardial infarction),
• History of the following musculoskeletal disorders: rheumatoid arthritis, avascular necrosis or osteonecrosis, severe osteoarthritis
• History of the following neurological disorders: Alzheimer\'s disease, amyotrophic lateral sclerosis, peripheral neuropathy, Parkinson\'s disease, severe traumatic brain injury,
• Varicose veins in the lower limb,
• Acute viral or bacterial upper or lower respiratory infection at screening, Known or suspected lower limb chronic exertional compartment syndrome (CECS) (tourniquet raises intra-compartmental muscle pressure),
• Surgical insertion of metal components at the position of cuff inflation,
• History of any of the following conditions or disorders not previously listed:

diabetes, active cancer,

• History of elevated risk of unexplained fainting or dizzy spells during physical activity and/or exercise that causes loss of balance,
• Increased risk of haemorrhagic stroke, exercise induced rhabdomyolysis,
• Currently pregnant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Defence Medical Rehabilitation Centre, Stanford Hall — Loughborough

Publications

• Gray L, Coppack RJ, Barker-Davies R, Cassidy RP, Bennett AN, Caplan N, Atkinson G, Bradshaw L, Chauhan J, Lunt KM, Hughes L, Ladlow P. Efficacy and acceptability of different blood flow restriction training interventions during the rehabilitation of military personnel with lower limb musculoskeletal injuries: protocol for a two-phase randomised controlled trial. BMJ Open. 2025 May 26;15(5):e096643 PMID 40425246

Identifiers

NCT: NCT06621953 · 2318/MODREC/24b

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗