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| Name | Class |
|---|---|
| University of Bath | OTHER |
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In 2018, the Academic Department of Military Rehabilitation (ADMR) published a pilot randomised controlled trial (RCT), demonstrating the feasibility and acceptability of integrating twice-daily blood flow restriction (BFR) training into a busy residential care setting. Following its publication was a guidance note written by the Directorate of Defence Rehabilitation restricting the implementation of BFR training until more evidence can be provided to support its efficacy. This research trial is a fully-powered, multi-centre RCT investigating the efficacy and biological mechanism underpinning BFR therapy in UK military personnel with lower-limb musculoskeletal injury (specifically, persistent anterior knee pain) during residential rehabilitation. This study will aim to optimise both the rehabilitation outcome and improve the time-and cost-effectiveness of the service delivered across UK Defence Rehabilitation and beyond. Results will provide 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 in the UK and abroad.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-load blood flow restriction training (LL-BFR) | Experimental | Twice daily LL-BFR for 3 weeks |
|
| Heavier load resistance training (HL-RT) | Active Comparator | Three sessions per week for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance Training | Other | Comparing two different exercise-based treatment methodologies on the clinical outcomes of individuals with persistent knee pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Extremity Functional Scale (LEFS) over time | LEFS is a 20-question patient-reported outcome measure (PROM) that measures functional status in patients with lower limb musculoskeletal injury. Questions on activity vary in physical demand from walking to running on uneven ground. The LEFS is a validated tool and has demonstrated good test-retest reliability and responsiveness in individuals with persistent knee pain. | Baseline, week 3 and week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) over time | Baseline, week 3 and week 15 | |
| Change in Patient Specific Functional Scale over time | Baseline, week 3 and week 15 | |
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Inclusion Criteria:
Exclusion Criteria:
diagnosed tibial, femoral or patella fracture and/or dislocation;
Medical Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Ladlow, PhD | Contact | +44 (0)1509251500 | 3403 | peter.ladlow100@mod.gov.uk |
| Russ Coppack, PhD | Contact | +44(0)1509251500 | 4418 | Russ.Coppack100@mod.gov.uk |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Bennett, PhD | Defence Medical Rehabilitation Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RRU Aldershot | Recruiting | Aldershot | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37461024 | Derived | Cassidy RP, Lunt KM, Coppack RJ, Bennett AN, Bilzon JLJ, Mcguigan MP, Egginton N, Sellon E, Day J, Ladlow P. ADAPTations to low load blood flow restriction exercise versus conventional heavier load resistance exercise in UK military personnel with persistent knee pain: protocol for the ADAPT study, a multi-centre randomized controlled trial. BMC Musculoskelet Disord. 2023 Jul 17;24(1):580. doi: 10.1186/s12891-023-06693-3. |
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Anonymised participant data will be made available upon reasonable request to the chief investigator.
Upon completion of the dissemination of research findings (i.e, publications and conference proceedings)
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.
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Change in Musculoskeletal Health Questionnaire (MSK-HQ) over time |
| Baseline, week 3 and week 15 |
| Change in Tampa Scale of Kinesiophobia (TSK) over time | Baseline, week 3 and week 15 |
| Health Anxiety Depression Scale (HADS) | Baseline |
| Change in International Physical Activity Questionnaire (IPAQ) over time | Baseline, week 3 and week 15 |
| Change in Numeric Pain Rating Scale (NPRS) over time | Baseline, week 3 and week 15 |
| Change in Sport Injury Rehabilitation Beliefs Survey (SIRBS) over time | Baseline, week 3 and week 15 |
| Change in functional Activity Assessment (FAA) over time | Baseline and week 15 |
| Change in five Repetition Maximum Leg Press over time | Baseline, week 3 and week 15 |
| Change in isometric muscle strength of hip and knee using hand-held dynamometer over time | Baseline, week 3 and week 15 |
| Change in single leg heel raises to fatigue over time | Baseline, week 3 and week 15 |
| Change in qualitative assessment of single leg squat (QASLS) over time | Baseline, week 3 and week 15 |
| Change in decline knee bend over time | Baseline, week 3 and week 15 |
| Change in isometric midthigh pull over time | Baseline, week 3 and week 15 |
| Change in counter-movement jump over time | Baseline, week 3 and week 15 |
| Change in knee extension and flexion - maximal isometric voluntary contraction over time | Baseline, week 3 and week 15 |
| Change in muscle volume and anatomical cross sectional area (CSA) using magnetic resonance imaging (MRI) over time | Baseline, week 3 and week 15 |
| Change in pennation angle over time using ultrasonography | Pennation angle measured in degrees | Baseline, week 3 and week 15 |
| Change in fascicle length over time using ultrasonography | fascicle length measured in mm | Baseline, week 3 and week 15 |
| Change in single leg squat over time - kinetic and kinematic analysis | 3D motion capture and force plate data will be used to collect kinetic and kinematic data which will be later analysed using inverse dynamics. Force measured in Newtons, Moments measured in Newton/Metres/kg | Baseline, week 3 and week 15 |
| Change in bilateral squat over time - kinetic and kinematic analysis | 3D motion capture and force plate data will be used to collect kinetic and kinematic data which will be later analysed using inverse dynamics. Force measured in Newtons, Moments measured in Newton/Metres/kg | Baseline, week 3 and week 15 |
| Change in markers of muscle damage over time | Using fasted blood samples. E.g., Creatine Kinase (units/L) | Baseline, week 3 and week 15 |
| Change in markers of oxidative stress over time | Using fasted blood samples. E.g., Protein carbonyl (units/L) | Baseline, week 3 and week 15 |
| Change in markers of inflammation over time | Using fasted blood samples. E.g., Interleukin-6 (pg/ml) | Baseline, week 3 and week 15 |
| Change in markers of endothelial function over time | Using fasted blood samples. E.g., Vascular endothelial growth factor (µg/L) | Baseline, week 3 and week 15 |
| Change in daily monitoring of wellness score over time | Subjective patient reported outcome measure of 'wellness' scored using a 5-point likert scale. | Daily for the 3 weeks of rehabilitation |
| Change in daily monitoring of session rate of perceived exertion (sRPE) over time | Subjective patient reported outcome measure of exertion, scored 0 to 10 (0 = no exertion, 10= maximal exertion) | Daily for the 3 weeks of rehabilitation |
| Change in daily monitoring of pain over time | Subjective patient reported outcome measure of pain measured using a 0 to 100mm visual analog scale (VAS). 0= no pain, 100 = worst pain | Daily for the 3 weeks of rehabilitation |
| RRU Colchester | Recruiting | Colchester | United Kingdom |
|
| RRU Cranwell | Recruiting | Cranwell | United Kingdom |
| RRU Edinburgh | Recruiting | Edinburgh | United Kingdom |
|
| RRU St Athan | Recruiting | St Athan | United Kingdom |
| RRU Bulford | Recruiting | Tidworth | United Kingdom |
|
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |