The ADAPTation to Therapeutic Resistance Training (ADAPT) Study

Muscle Weakness Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719922
• Other study ID #: DefenceMedRC
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2023
• Source: Defence Medical Rehabilitation Centre, UK
• Contact: Peter Ladlow, PhD
• Phone: +44 (0)1509251500
• Email: peter.ladlow100[@]mod.gov.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Musculoskeletal Injury

Intervention

Other:
• Resistance Training
Comparing two different exercise-based treatment methodologies on the clinical outcomes of individuals with persistent knee pain.

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (2)

Lead Sponsor	Collaborator
Defence Medical Rehabilitation Centre, UK	University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) over time		Baseline, week 3 and week 15
Secondary	Change in Patient Specific Functional Scale over time		Baseline, week 3 and week 15
Secondary	Change in Musculoskeletal Health Questionnaire (MSK-HQ) over time		Baseline, week 3 and week 15
Secondary	Change in Tampa Scale of Kinesiophobia (TSK) over time		Baseline, week 3 and week 15
Secondary	Health Anxiety Depression Scale (HADS)		Baseline
Secondary	Change in International Physical Activity Questionnaire (IPAQ) over time		Baseline, week 3 and week 15
Secondary	Change in Numeric Pain Rating Scale (NPRS) over time		Baseline, week 3 and week 15
Secondary	Change in Sport Injury Rehabilitation Beliefs Survey (SIRBS) over time		Baseline, week 3 and week 15
Secondary	Change in functional Activity Assessment (FAA) over time		Baseline and week 15
Secondary	Change in five Repetition Maximum Leg Press over time		Baseline, week 3 and week 15
Secondary	Change in isometric muscle strength of hip and knee using hand-held dynamometer over time		Baseline, week 3 and week 15
Secondary	Change in single leg heel raises to fatigue over time		Baseline, week 3 and week 15
Secondary	Change in qualitative assessment of single leg squat (QASLS) over time		Baseline, week 3 and week 15
Secondary	Change in decline knee bend over time		Baseline, week 3 and week 15
Secondary	Change in isometric midthigh pull over time		Baseline, week 3 and week 15
Secondary	Change in counter-movement jump over time		Baseline, week 3 and week 15
Secondary	Change in knee extension and flexion - maximal isometric voluntary contraction over time		Baseline, week 3 and week 15
Secondary	Change in muscle volume and anatomical cross sectional area (CSA) using magnetic resonance imaging (MRI) over time		Baseline, week 3 and week 15
Secondary	Change in pennation angle over time using ultrasonography	Pennation angle measured in degrees	Baseline, week 3 and week 15
Secondary	Change in fascicle length over time using ultrasonography	fascicle length measured in mm	Baseline, week 3 and week 15
Secondary	Change in single leg squat over time - kinetic and kinematic analysis	3D motion capture and force plate data will be used to collect kinetic and kinematic data which will be later analysed using inverse dynamics. Force measured in Newtons, Moments measured in Newton/Metres/kg	Baseline, week 3 and week 15
Secondary	Change in bilateral squat over time - kinetic and kinematic analysis	3D motion capture and force plate data will be used to collect kinetic and kinematic data which will be later analysed using inverse dynamics. Force measured in Newtons, Moments measured in Newton/Metres/kg	Baseline, week 3 and week 15
Secondary	Change in markers of muscle damage over time	Using fasted blood samples. E.g., Creatine Kinase (units/L)	Baseline, week 3 and week 15
Secondary	Change in markers of oxidative stress over time	Using fasted blood samples. E.g., Protein carbonyl (units/L)	Baseline, week 3 and week 15
Secondary	Change in markers of inflammation over time	Using fasted blood samples. E.g., Interleukin-6 (pg/ml)	Baseline, week 3 and week 15
Secondary	Change in markers of endothelial function over time	Using fasted blood samples. E.g., Vascular endothelial growth factor (µg/L)	Baseline, week 3 and week 15
Secondary	Change in daily monitoring of wellness score over time	Subjective patient reported outcome measure of 'wellness' scored using a 5-point likert scale.	Daily for the 3 weeks of rehabilitation
Secondary	Change in daily monitoring of session rate of perceived exertion (sRPE) over time	Subjective patient reported outcome measure of exertion, scored 0 to 10 (0 = no exertion, 10= maximal exertion)	Daily for the 3 weeks of rehabilitation
Secondary	Change in daily monitoring of pain over time	Subjective patient reported outcome measure of pain measured using a 0 to 100mm visual analog scale (VAS). 0= no pain, 100 = worst pain	Daily for the 3 weeks of rehabilitation