The ADAPTation to Therapeutic Resistance Training (ADAPT) Study

Last updated: January 30, 2023
Sponsor: Defence Medical Rehabilitation Centre, UK
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polymyositis (Inflammatory Muscle Disease)

Sarcopenia

Treatment

N/A

Clinical Study ID

NCT05719922
DefenceMedRC
  • Ages 18-55
  • All Genders

Study 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

Inclusion Criteria:

  • mechanical knee pain for at least three months
  • present with clinical signs and symptoms of knee pain arising from the tibiofemoral orpatellofemoral joint diagnosed by sport and exercise medicine physician and/orphysiotherapist
  • have reduced occupational employability medical grade secondary to their knee pain
  • report progression of resistance training load within the patient's rehabilitationprogramme 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

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-musculoskeletalor 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-vasculardisease) precluding the safe participation in the rehabilitation programme and/orassessment procedures
  • Cortico-steroid or analgesic injection intervention within the previous 7-days orprevious 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, avascularnecrosis or osteonecrosis, severe osteoarthritis.
  • History of the following neurological disorders: Peripheral neuropathy, Alzheimer'sdisease, amyotrophic lateral sclerosis, Parkinson's disease, severe traumatic braininjury.
  • 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 physicalactivity/exercise that causes loss of balance
  • History of haemorrhagic stroke or exercise induced rhabdomyolysis

Study Design

Total Participants: 150
Study Start date:
December 01, 2022
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • RRU Aldershot

    Aldershot,
    United Kingdom

    Active - Recruiting

  • RRU Colchester

    Colchester,
    United Kingdom

    Active - Recruiting

  • RRU Cranwell

    Cranwell,
    United Kingdom

    Active - Recruiting

  • RRU Edinburgh

    Edinburgh,
    United Kingdom

    Active - Recruiting

  • RRU St Athan

    St Athan,
    United Kingdom

    Active - Recruiting

  • RRU Bulford

    Tidworth,
    United Kingdom

    Active - Recruiting

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