The ADAPTation to Therapeutic Resistance Training (ADAPT) Study

N/AUnknownNCT05719922

Defence Medical Rehabilitation Centre, UK150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Musculoskeletal Injury Muscle Weakness

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.