Musculoskeletal InjuryNCT05719922
The ADAPTation to Therapeutic Resistance Training (ADAPT) Study
A study testing Resistance Training in people with Musculoskeletal Injury and Muscle Weakness, run by Defence Medical Rehabilitation Centre, UK at 6 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Musculoskeletal Injury, Muscle Weakness
- What is being tested?
- Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 1 Dec 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites, 6 recruiting
- Recruiting
RRU Aldershot
Aldershot
Ollie Rosenstock
- Recruiting
RRU Colchester
Colchester
Rachel Spanner
- Recruiting
RRU Cranwell
Cranwell
- Recruiting
RRU Edinburgh
Edinburgh
Gordon McKay
- Recruiting
RRU St Athan
St Athan
- Recruiting
RRU Bulford
Tidworth
Alice Essam
About this study
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
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.
- Conditions
- Musculoskeletal Injury, Muscle Weakness
- Being tested
- Resistance Training
- Keywords
- Musculoskeletal rehabilitation, Blood flow restriction, Resistance training, knee pain, military
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
Comparing two different exercise-based treatment methodologies on the clinical outcomes of individuals with persistent knee pain.
| Study group | Role | What they receive |
|---|---|---|
| Low-load blood flow restriction training (LL-BFR) | Experimental | Twice daily LL-BFR for 3 weeks Receives: Other: Resistance Training |
| Heavier load resistance training (HL-RT) | Active comparator | Three sessions per week for 3 weeks Receives: Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 3 and week 15
Secondary outcomes (29)
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) over time
Measured: Baseline, week 3 and week 15
Change in Patient Specific Functional Scale over time
Measured: Baseline, week 3 and week 15
Change in Musculoskeletal Health Questionnaire (MSK-HQ) over time
Measured: Baseline, week 3 and week 15
Change in Tampa Scale of Kinesiophobia (TSK) over time
Measured: Baseline, week 3 and week 15
Health Anxiety Depression Scale (HADS)
Measured: Baseline
Change in International Physical Activity Questionnaire (IPAQ) over time
Measured: Baseline, week 3 and week 15
Change in Numeric Pain Rating Scale (NPRS) over time
Measured: Baseline, week 3 and week 15
Change in Sport Injury Rehabilitation Beliefs Survey (SIRBS) over time
Measured: Baseline, week 3 and week 15
Change in functional Activity Assessment (FAA) over time
Measured: Baseline and week 15
Change in five Repetition Maximum Leg Press over time
Measured: Baseline, week 3 and week 15
Change in isometric muscle strength of hip and knee using hand-held dynamometer over time
Measured: Baseline, week 3 and week 15
Change in single leg heel raises to fatigue over time
Measured: Baseline, week 3 and week 15
Change in qualitative assessment of single leg squat (QASLS) over time
Measured: Baseline, week 3 and week 15
Change in decline knee bend over time
Measured: Baseline, week 3 and week 15
Change in isometric midthigh pull over time
Measured: Baseline, week 3 and week 15
Change in counter-movement jump over time
Measured: Baseline, week 3 and week 15
Change in knee extension and flexion - maximal isometric voluntary contraction over time
Measured: Baseline, week 3 and week 15
Change in muscle volume and anatomical cross sectional area (CSA) using magnetic resonance imaging (MRI) over time
Measured: Baseline, week 3 and week 15
Change in pennation angle over time using ultrasonography
Pennation angle measured in degrees
Measured: Baseline, week 3 and week 15
Change in fascicle length over time using ultrasonography
fascicle length measured in mm
Measured: Baseline, week 3 and week 15
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
Measured: Baseline, week 3 and week 15
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
Measured: Baseline, week 3 and week 15
Change in markers of muscle damage over time
Using fasted blood samples. E.g., Creatine Kinase (units/L)
Measured: Baseline, week 3 and week 15
Change in markers of oxidative stress over time
Using fasted blood samples. E.g., Protein carbonyl (units/L)
Measured: Baseline, week 3 and week 15
Change in markers of inflammation over time
Using fasted blood samples. E.g., Interleukin-6 (pg/ml)
Measured: Baseline, week 3 and week 15
Change in markers of endothelial function over time
Using fasted blood samples. E.g., Vascular endothelial growth factor (µg/L)
Measured: Baseline, week 3 and week 15
Change in daily monitoring of wellness score over time
Subjective patient reported outcome measure of 'wellness' scored using a 5-point likert scale.
Measured: Daily for the 3 weeks of rehabilitation
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)
Measured: Daily for the 3 weeks of rehabilitation
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
Measured: Daily for the 3 weeks of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Dec 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Defence Medical Rehabilitation Centre, UK
- Sponsor type
- Other government
- Collaborators
- University of Bath
- Responsible party
- Principal investigator, Peter Ladlow, Defence Medical Rehabilitation Centre, UK
- Investigators
- Alexander Bennett, PhD, Study chair, Defence Medical Rehabilitation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719922
- Sponsor's protocol ID
- DefenceMedRC
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised participant data will be made available upon reasonable request to the chief investigator.
Publications
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.
PubMed 37461024
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05719922
- Acronym / sponsor ID
- DefenceMedRC
- Conditions
- Musculoskeletal Injury, Muscle Weakness
- Keywords
- Musculoskeletal rehabilitation, Blood flow restriction, Resistance training, knee pain, military
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Defence Medical Rehabilitation Centre, UKOther government
- Collaborators
- University of Bath
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-load blood flow restriction training (LL-BFR) | Experimental | Other: Resistance TrainingTwice daily LL-BFR for 3 weeks |
| Heavier load resistance training (HL-RT) | Active comparator | Other: Resistance TrainingThree sessions per week for 3 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance TrainingComparing two different exercise-based treatment methodologies on the clinical outcomes of individuals with persistent knee pain. | Other | Heavier load resistance training (HL-RT), Low-load blood flow restriction training (LL-BFR) |
Primary outcome
Change in Lower Extremity Functional Scale (LEFS) over time
Time frame: Baseline, week 3 and week 15
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.
29 secondary outcomes
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) over time
Time frame: Baseline, week 3 and week 15
Change in Patient Specific Functional Scale over time
Time frame: Baseline, week 3 and week 15
Change in Musculoskeletal Health Questionnaire (MSK-HQ) over time
Time frame: Baseline, week 3 and week 15
Change in Tampa Scale of Kinesiophobia (TSK) over time
Time frame: Baseline, week 3 and week 15
Health Anxiety Depression Scale (HADS)
Time frame: Baseline
Change in International Physical Activity Questionnaire (IPAQ) over time
Time frame: Baseline, week 3 and week 15
Change in Numeric Pain Rating Scale (NPRS) over time
Time frame: Baseline, week 3 and week 15
Change in Sport Injury Rehabilitation Beliefs Survey (SIRBS) over time
Time frame: Baseline, week 3 and week 15
Change in functional Activity Assessment (FAA) over time
Time frame: Baseline and week 15
Change in five Repetition Maximum Leg Press over time
Time frame: Baseline, week 3 and week 15
Change in isometric muscle strength of hip and knee using hand-held dynamometer over time
Time frame: Baseline, week 3 and week 15
Change in single leg heel raises to fatigue over time
Time frame: Baseline, week 3 and week 15
Change in qualitative assessment of single leg squat (QASLS) over time
Time frame: Baseline, week 3 and week 15
Change in decline knee bend over time
Time frame: Baseline, week 3 and week 15
Change in isometric midthigh pull over time
Time frame: Baseline, week 3 and week 15
Change in counter-movement jump over time
Time frame: Baseline, week 3 and week 15
Change in knee extension and flexion - maximal isometric voluntary contraction over time
Time frame: Baseline, week 3 and week 15
Change in muscle volume and anatomical cross sectional area (CSA) using magnetic resonance imaging (MRI) over time
Time frame: Baseline, week 3 and week 15
Change in pennation angle over time using ultrasonography
Time frame: Baseline, week 3 and week 15
Change in fascicle length over time using ultrasonography
Time frame: Baseline, week 3 and week 15
Change in single leg squat over time - kinetic and kinematic analysis
Time frame: Baseline, week 3 and week 15
Change in bilateral squat over time - kinetic and kinematic analysis
Time frame: Baseline, week 3 and week 15
Change in markers of muscle damage over time
Time frame: Baseline, week 3 and week 15
Change in markers of oxidative stress over time
Time frame: Baseline, week 3 and week 15
Change in markers of inflammation over time
Time frame: Baseline, week 3 and week 15
Change in markers of endothelial function over time
Time frame: Baseline, week 3 and week 15
Change in daily monitoring of wellness score over time
Time frame: Daily for the 3 weeks of rehabilitation
Change in daily monitoring of session rate of perceived exertion (sRPE) over time
Time frame: Daily for the 3 weeks of rehabilitation
Change in daily monitoring of pain over time
Time frame: Daily for the 3 weeks of rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Derived from this study: PubMed 37461024Cassidy 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.
- Individual participant dataSharing planned: Yes. Anonymised participant data will be made available upon reasonable request to the chief investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Bennett, PhD study chair
Defence Medical Rehabilitation Centre
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Musculoskeletal Injury and Muscle Weakness, run by Defence Medical Rehabilitation Centre, UK at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Ladlow, PhD (+44 (0)1509251500 ext. 3403, peter.ladlow100@mod.gov.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lower Extremity Functional Scale (LEFS) over time (time frame: Baseline, week 3 and week 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05719922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.