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

Официальное название

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)

Обзор

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.

Вмешательства

• Устройство 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.
• Другое 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

Первичные конечные точки

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

Вторичные конечные точки (12)

• 5-RM Testing [Срок оценки: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)]
• Numerical Pain Rating Scale [Срок оценки: 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 [Срок оценки: T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).]
• Training Load [Срок оценки: T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).]
• Copenhagen Hip and Groin Score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: T2, Daily (before BFR session; days 1-5, 6-10 and 11-15).]
• Isometric Mid-Thigh Pull [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Defence Medical Rehabilitation Centre, Stanford Hall — Loughborough

Публикации

• 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

Идентификаторы

NCT: NCT06621953 · 2318/MODREC/24b

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗