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Recruiting NCT05719922

The ADAPTation to Therapeutic Resistance Training (ADAPT) Study

Conditions: Musculoskeletal Injury, Muscle Weakness

Sex: All
Ages: 18 Years – 55 Years
Phase: NA
Enrollment: 150
Sponsor: Defence Medical Rehabilitation Centre, UK

Location: United Kingdom

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 monthspresent with clinical signs and symptoms of knee pain arising from the tibiofemoral or patellofemoral joint diagnosed by sport and exercise medicine physician and/or physiotherapisthave reduced occupational employability medical grade secondary to their knee painreport progression of resistance training load within the patient's rehabilitation programme is limited by knee painaged between 18 and 55 yearsavailable 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 deficiencypresent with clinical signs and symptoms of patellar tendinopathyhave planned surgery over the study periodrestricted 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 sourcepresent with any physical impairment or co-morbidities (including cardio-vascular disease) precluding the safe participation in the rehabilitation programme and/or assessment proceduresCortico-steroid or analgesic injection intervention within the previous 7-days or previous knee surgery within the last 12 months to the affected limbMedical 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 limbAcute viral or bacterial upper or lower respiratory infection at screeningKnown or suspected lower limb chronic exertional compartment syndrome (CECS)Postsurgical swellingSurgical insertion of metal components at the position of cuff inflationHistory of any of the following conditions or disorders not previously listed: diabetes, active cancerHistory of elevated risk of unexplained fainting or dizzy spells during physical activity/exercise that causes loss of balanceHistory of haemorrhagic stroke or exercise induced rhabdomyolysis

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05719922). StuddyBuddy aggregates publicly available trial information.