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. 2025 May 26;15(5):e096643.
doi: 10.1136/bmjopen-2024-096643.

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

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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

Luke Gray et al. BMJ Open. .

Abstract

Background: Musculoskeletal injury (MSKI) is the leading cause of medical downgrading and discharge within the UK military, with lower limb MSKI having the greatest incidence, negatively impacting operational readiness. Pain is a primary limiting factor to rehabilitation progress following MSKI. Heavy-load resistance training (RT; ie, loads >70% 1-repetition maximum) is traditionally used but may be contraindicated due to pain, potentially prolonging recovery and leading to failure of essential physical employment standards for UK military personnel. Low-load RT with blood flow restriction (BFR) can promote favourable morphological and physiological adaption, as well as elicit hypoalgesia in healthy and clinical populations (eg, post-operative), and has proven a viable option in military rehabilitation settings. The acceptability and tolerance of higher relative BFR pressures in persistent pain populations are unknown due to the complexity of presentation and the perception of discomfort experienced during BFR exercise. Greater relative pressures (ie, 80% limb occlusion pressure (LOP)) elicit a greater hypoalgesic response in pain-free individuals, but greater perceived discomfort which may not be tolerated in persistent pain populations. However, lower relative pressure (ie, 40% LOP) has elicited hypoalgesia in pain-free individuals, which therefore may be more clinically acceptable and tolerated in persistent pain populations. The primary aim of both randomised controlled trials (RCT) is to investigate the efficacy and acceptability of using high-frequency, low-load BFR-RT in UK military personnel with lower limb MSKI where persistent pain is the primary limiting factor for progression.

Methodology: The presented protocol is a two-phase RCT based within a military rehabilitation setting. Phase One is a 1-week RCT to determine the most efficacious and acceptable BFR-RT protocol (7× BFR-RT sessions over 5 days at 40% or 80% LOP; n=28). Phase Two is a 3-week RCT comparing the most clinically acceptable BFR pressure, determined by Phase One (21× BFR-RT sessions over 15 days; n=26) to usual care within UK Defence Rehabilitation residential rehabilitation practices. Outcomes will be recorded at baseline, daily and following completion of the intervention. The primary outcome will be the brief pain inventory. Secondary outcomes include blood biomarkers for inflammation and pain (Phase Two only), injury-specific outcome measures, lower extremity function scale, objective measures of muscle strength and neuromuscular performance, and pressure pain threshold testing.

Ethics and dissemination: The study is approved by the Ministry of Defence Research Ethics Committee (2318/MODREC/24) and Northumbria University. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.

Trial registration number: Registered with Clinical Trials. The registration numbers are as follows: NCT06621914 (Phase One) and NCT06621953 (Phase Two).

Keywords: Exercise; Lower Extremity; REHABILITATION MEDICINE; SPORTS MEDICINE.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1. Study design flow diagram: Phase One. Phase One timepoints—T0P1, baseline (day −3); T1P1, admission day (day 1); T2P1, daily (days 1–5); T3P1, end of intervention (day 5); T4P1, follow-up (day 6). BFR40, blood flow restriction with resistance training at 40% limb occlusion pressure; BFR80, blood flow restriction with resistance training at 80% limb occlusion pressure; DMRC, Defence Medical Rehabilitation Centre.
Figure 2
Figure 2. Timepoints of data collection for Phase One RCT (top) and Phase Two RCT (bottom). Phase One timepoints—T0P1, baseline (day −3); T1P1, admission day (day 1); T2P1, daily (days 1–5); T3P1, end of intervention (day 5); T4P1, follow-up (day 6). Phase Two timepoints—T0P2, baseline (day −3); T1P2, admission day (day 1); T2P2, daily (days 1–5, 6–10, 11–15); T3P2, start and end of residential rehabilitation weeks (days 1 and 5, 6 and 10, and 11 and 15); T4P2, end of intervention (day 15). BFR, blood flow restriction; BFR40, blood flow restriction with resistance training at 40% limb occlusion pressure; BFR80, blood flow restriction with resistance training at 80% limb occlusion pressure; RCT, randomised controlled trials.
Figure 3
Figure 3. Study design flow diagram: Phase Two. Phase Two timepoints—T0P2, baseline (day −3); T1P2, admission day (day 1); T2P2, daily (days 1–5, 6–10, 11–15); T3P2, start and end of residential rehabilitation weeks (days 1 and 5, 6 and 10, and 11 and 15); T4P2, end of intervention (day 15). BFR, blood flow restriction with resistance training; CON, standard residential rehabilitation/usual care group; DMRC, Defence Medical Rehabilitation Centre.

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