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

NCT06621914 | Recruiting

• 1 other identifier: 2318/MODREC/24a
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Persistent Pain; Musculoskeletal Pain

Keywords

blood flow restriction; persistent pain; hypoalgesia

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory

  The BPI is a patient administered, multi-dimensional, pain assessment tool commonly used within musculoskeletal clinical practice. Higher scores on the 9-item short form indicate greater interference with function, or greater pain intensity.

  Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).

Secondary Outcomes (21)

• Pressure Pain Threshold Testing

  Pre-intervention (day 0), daily (before, immediately-post, and 1hr-post each BFR session; days 1-5), post-intervention (day 5) and at follow-up (day 8).

• Lower Extremity Function Scale

  Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).

• Isometric Mid-Thigh Pull

  Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8).

• 5-RM Testing

  Pre-intervention (day 0) and follow-up (day 8).

• Numerical Pain Rating Scale

  Daily (before, immediately-post, and 1 hour-post each BFR session; days 1-5).

Study Arms (2)

BFR80

EXPERIMENTAL

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).

Device: BFR 80

BFR40

ACTIVE COMPARATOR

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).

Device: BFR40

Interventions

BFR 80 DEVICE

The intervention involves placing a pneumatic tourniquet system over the proximal thigh. The cuff is inflated to 80% of limb occlusion pressure during lower limb strengthening exercises. These exercises include leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum.

Also known as: Blood flow restriction training, Occlusion training

BFR80

BFR40 DEVICE

The intervention involves placing a pneumatic tourniquet system over the proximal thigh. The cuff is inflated to 40% of limb occlusion pressure during lower limb strengthening exercises. These exercises include leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum.

Also known as: Blood flow restriction training, Occlusion training

BFR40

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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,

Sponsors & Collaborators

• Defence Medical Rehabilitation Centre, UK: lead
• Northumbria University: collaborator

Study Sites (1)

Defence Medical Rehabilitation Centre, Stanford Hall

Loughborough, Leicestershire, LE12 5QW, United Kingdom

RECRUITING

Related Publications (1)

• 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. doi: 10.1136/bmjopen-2024-096643.

  PMID: 40425246 DERIVED

MeSH Terms

Conditions

Pain; Musculoskeletal Pain

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Peter Ladlow, PhD

  Defence Medical Rehabilitation Centre, UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Ladlow, PhD

CONTACT

+44 1509 251 500; peter.ladlow100@mod.gov.uk

Luke Hughes, PhD

CONTACT

luke4.hughes@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, it is not possible to blind participants or outcome assessors to the treatment allocation. There is also no effective sham condition available. This is a common limitation within all blood flow restriction training research.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator and Exercise Physiology Lead for UK Defence Rehabilitation

Model Details: The overall study is a two phase RCT. Phase one will investigate two different BFR-RT protocols (high- vs low-pressure) for 1-week (7x BFR-RT sessions in 5 days). Phase two will take the BFR-RT protocol that elicited the greatest improvement in symptoms (high- or low-pressure) and compare that to conventional Uk Defence Rehabilitation practices over a 3 week period (21x BFR-RT sessions over 15 days).

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 23, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon completion of the dissemination of research findings (i.e., publications and conference proceedings).
• Access Criteria: Most data will be openly available, but due to privacy concerns, some data regarding participants are available only to bona fide researchers working on a related project, subject to the completion of a non-disclosure agreement.

Locations

GB (1)