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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorDefence Medical Rehabilitation Centre, UK

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BFR

    Device

    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.

  • control group

    Other intervention

    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., dietetics, occupational therapy, physiotherapy, podiatry, prosthesis/orthosis specialists, social workers, and speech and language therapists).

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: BFRExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

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.

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 outcomes

1

5-RM Testing

5-RM assessment on leg press and leg/knee extension machines (leg/knee extension pre-intervention only) to assess the participants strength, and inform % load for intervention period. Testing procedure: 5-minute cycling warm up, followed by 10-rep exercise specific warm up, and then successive attempts at performing a 5RM on injured limb only. The authors acknowledge that due to the likely interference effect of a pain response, performing a \'maximum effort\' physical task in a lower limb injured cohort is unlikely to yield a true measure of MSK performance. It is more accurate to describe outcome scores as providing an \'indication\' of participant performance and progression. We will highlight this as a potential weakness in our study but feel this is a challenge in the measurement of muscle force / strength in all MSK injury research. All outcomes measured will be implemented and recorded based upon a best effort at the time of assessment.

Time frame
T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
2

Numerical Pain Rating Scale

To assess the feasibility and tolerability of the BFR-RT interventions, a participant monitoring booklet will be used throughout the intervention period. The Numerical Pain Rating Scale (NPRS) for injury-specific pain and localised muscle soreness will be collected pre-intervention, immediately post-intervention, and 1-hour post-intervention for each BFR-RT session.

Time frame
T2, Daily (before, immediately-post, and 1 hour-post each BFR session; days 1-5, 6-10 and 11-15).
3

Sessional Rate of Perceived Exertion

To assess the feasibility and tolerability of the BFR-RT interventions, a participant monitoring booklet will be used throughout the intervention period. Sessional Rate of Perceived Exertion (scored 0-10; 0=no effort, 10=maximal effort) will be collected following each BFR-RT session.

Time frame
T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).
4

Training Load

To assess the feasibility and tolerability of the BFR-RT interventions, a participant monitoring booklet will be used throughout the intervention period. To quantify training load, the following calculation will be conducted following each BFR-RT session; sets x reps x load (kg). Specific Example: BFR-RT Leg Press at 25kg 1 set x 30 reps + 3 sets x 15 reps = 75 reps 75 (reps) x 25 (kg) = 1875 (training load)

Time frame
T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).

Other outcomes

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