Clinical trial NCT05719922: The ADAPTation to Therapeutic Resistance Training (ADAPT) Study
Official title: Low-load Blood Flow Restriction Exercise Versus Conventional Heavier Load Resistance Training Exercise in UK Military Personnel With Persistent Knee Pain: A Multi-centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Injury
Muscle Weakness
Keywords: Musculoskeletal rehabilitation
Blood flow restriction
Resistance training
knee pain
military
Lead sponsor: Defence Medical Rehabilitation Centre, UK
Sponsor class: OTHER_GOV
Collaborators: name: University of Bath
First posted: 2023-02-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* mechanical knee pain for at least three months
* present with clinical signs and symptoms of knee pain arising from the tibiofemoral or patellofemoral joint diagnosed by sport and exercise medicine physician and/or physiotherapist
* have reduced occupational employability medical grade secondary to their knee pain
* report progression of resistance training load within the patient's rehabilitation programme is limited by knee pain
* aged between 18 and 55 years
* available to attend for the entire duration of the RRU course and a review appointment 3-months following course.

Exclusion Criteria:

diagnosed tibial, femoral or patella fracture and/or dislocation;

* present with instability in the knee resulting from ligament deficiency
* present with clinical signs and symptoms of patellar tendinopathy
* have planned surgery over the study period
* restricted knee range of movement; clinical signs and symptoms of non-musculoskeletal or serious pathological condition (i.e. Inflammatory arthropathy, infection or tumour) or referred pain from non-local pain source
* present with any physical impairment or co-morbidities (including cardio-vascular disease) precluding the safe participation in the rehabilitation programme and/or assessment procedures
* Cortico-steroid or analgesic injection intervention within the previous 7-days or previous knee surgery within the last 12 months to the affected limb

Medical Exclusion Criteria:

* History of cardiovascular disease including 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: Peripheral neuropathy, Alzheimer's disease, amyotrophic lateral sclerosis, 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)
* Postsurgical swelling
* 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/exercise that causes loss of balance
* History of haemorrhagic stroke or exercise induced rhabdomyolysis

Primary outcomes:
measure: Change in Lower Extremity Functional Scale (LEFS) over time
timeFrame: Baseline, week 3 and week 15
Secondary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) over time
timeFrame: Baseline, week 3 and week 15
measure: Change in Patient Specific Functional Scale over time
timeFrame: Baseline, week 3 and week 15
measure: Change in Musculoskeletal Health Questionnaire (MSK-HQ) over time
timeFrame: Baseline, week 3 and week 15
measure: Change in Tampa Scale of Kinesiophobia (TSK) over time
timeFrame: Baseline, week 3 and week 15
measure: Health Anxiety Depression Scale (HADS)
timeFrame: Baseline
measure: Change in International Physical Activity Questionnaire (IPAQ) over time
timeFrame: Baseline, week 3 and week 15
measure: Change in Numeric Pain Rating Scale (NPRS) over time
timeFrame: Baseline, week 3 and week 15
measure: Change in Sport Injury Rehabilitation Beliefs Survey (SIRBS) over time
timeFrame: Baseline, week 3 and week 15
measure: Change in functional Activity Assessment (FAA) over time
timeFrame: Baseline and week 15
measure: Change in five Repetition Maximum Leg Press over time
timeFrame: Baseline, week 3 and week 15
measure: Change in isometric muscle strength of hip and knee using hand-held dynamometer over time
timeFrame: Baseline, week 3 and week 15
measure: Change in single leg heel raises to fatigue over time
timeFrame: Baseline, week 3 and week 15
measure: Change in qualitative assessment of single leg squat (QASLS) over time
timeFrame: Baseline, week 3 and week 15
measure: Change in decline knee bend over time
timeFrame: Baseline, week 3 and week 15
measure: Change in isometric midthigh pull over time
timeFrame: Baseline, week 3 and week 15
measure: Change in counter-movement jump over time
timeFrame: Baseline, week 3 and week 15
measure: Change in knee extension and flexion - maximal isometric voluntary contraction over time
timeFrame: Baseline, week 3 and week 15
measure: Change in muscle volume and anatomical cross sectional area (CSA) using magnetic resonance imaging (MRI) over time
timeFrame: Baseline, week 3 and week 15
measure: Change in pennation angle over time using ultrasonography
timeFrame: Baseline, week 3 and week 15
measure: Change in fascicle length over time using ultrasonography
timeFrame: Baseline, week 3 and week 15
measure: Change in single leg squat over time - kinetic and kinematic analysis
timeFrame: Baseline, week 3 and week 15
measure: Change in bilateral squat over time - kinetic and kinematic analysis
timeFrame: Baseline, week 3 and week 15
measure: Change in markers of muscle damage over time
timeFrame: Baseline, week 3 and week 15
measure: Change in markers of oxidative stress over time
timeFrame: Baseline, week 3 and week 15
measure: Change in markers of inflammation over time
timeFrame: Baseline, week 3 and week 15
measure: Change in markers of endothelial function over time
timeFrame: Baseline, week 3 and week 15
measure: Change in daily monitoring of wellness score over time
timeFrame: Daily for the 3 weeks of rehabilitation
measure: Change in daily monitoring of session rate of perceived exertion (sRPE) over time
timeFrame: Daily for the 3 weeks of rehabilitation
measure: Change in daily monitoring of pain over time
timeFrame: Daily for the 3 weeks of rehabilitation
Other outcomes:
Locations:
city: Aldershot
country: United Kingdom
facility: RRU Aldershot
city: Colchester
country: United Kingdom
facility: RRU Colchester
city: Cranwell
country: United Kingdom
facility: RRU Cranwell
city: Edinburgh
country: United Kingdom
facility: RRU Edinburgh
city: St Athan
country: United Kingdom
facility: RRU St Athan
city: Tidworth
country: United Kingdom
facility: RRU Bulford
Study officials:
affiliation: Defence Medical Rehabilitation Centre
name: Alexander Bennett, PhD
role: STUDY_CHAIR
References: