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

Sponsor
Defence Medical Rehabilitation Centre, UK
Study ID
NCT06621914
Status
Recruiting
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Conditions

  • Musculoskeletal Pain
  • Pain
  • Persistent Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Oct 1, 2024
Start date
Oct 28, 2024
Status verified
Nov 2024
Primary completion
May 29, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BFR80
    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).
  • Active Comparator: BFR40
    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).

Primary Outcome Measure

Brief Pain Inventory [ Time Frame: Pre-intervention (day 0), post-intervention (day 5) and at follow-up (day 8). ]

Central Contacts

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