The ADAPTation to Therapeutic Resistance Training (ADAPT) Study
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
1 other identifier
interventional
150
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
February 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedFebruary 9, 2023
January 1, 2023
1.8 years
January 19, 2023
January 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (29)
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
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
- +24 more secondary outcomes
Study Arms (2)
Low-load blood flow restriction training (LL-BFR)
EXPERIMENTALTwice daily LL-BFR for 3 weeks
Heavier load resistance training (HL-RT)
ACTIVE COMPARATORThree sessions per week for 3 weeks
Interventions
Comparing two different exercise-based treatment methodologies on the clinical outcomes of individuals with persistent knee pain.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Defence Medical Rehabilitation Centre, UKlead
- University of Bathcollaborator
Study Sites (6)
RRU Aldershot
Aldershot, United Kingdom
RRU Colchester
Colchester, United Kingdom
RRU Cranwell
Cranwell, United Kingdom
RRU Edinburgh
Edinburgh, United Kingdom
RRU St Athan
St Athan, United Kingdom
RRU Bulford
Tidworth, United Kingdom
Related Publications (1)
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.
PMID: 37461024DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alexander Bennett, PhD
Defence Medical Rehabilitation Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Higher Scientific Officer
Study Record Dates
First Submitted
January 19, 2023
First Posted
February 9, 2023
Study Start
December 1, 2022
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
February 9, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Upon completion of the dissemination of research findings (i.e, publications and conference proceedings)
- Access Criteria
- 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.
Anonymised participant data will be made available upon reasonable request to the chief investigator.