Is Low-load Resistance Training With Blood Flow Restriction Feasible During Rehabilitation of Military Personnel With Lower Limb Injuries? Phase One RCT. (LIMITLESS)

Defence Medical Rehabilitation Centre, UK

Status: Enrolling

Conditions: Musculoskeletal Pain; Persistent Pain; Pain

Treatments: Device: BFR 80; Device: BFR40

Study type: Interventional

Funder types: Other

Identifiers

NCT06621914

2318/MODREC/24a

Details and patient eligibility

About

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 Rehabilitation, but also those working in civilian sector organisations and professional sport also.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

BFR80

Experimental group

Description:

Low load blood flow restriction training with high-pressure cuff (80% AOP) in addition to standard residential rehabilitation consisting 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., dietetics, occupational therapy, physiotherapy, podiatry, prosthesis/orthosis specialists, social workers, and speech and language therapists).

Treatment:

Device: BFR 80

BFR40

Active Comparator group

Description:

Low load blood flow restriction training with low-pressure cuff (40% AOP) in addition to standard residential rehabilitation consisting 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., dietetics, occupational therapy, physiotherapy, podiatry, prosthesis/orthosis specialists, social workers, and speech and language therapists).

Treatment:

Device: BFR40