Clinical trial NCT06334224: Acute Physiological Responses to Twice Daily Blood Flow Restriction Training
Official title: Effects of Twice Daily Blood Flow Restriction Training on Muscle Swelling, Markers of Exercise Induced Muscle Damage and Inflammation: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Weakness
Muscle Damage
Keywords: resistance training
blood flow restriction
exercise induced muscle damage
muscle swelling
occlusion
Lead sponsor: Defence Medical Rehabilitation Centre, UK
Sponsor class: OTHER_GOV
Collaborators: name: University of Bath
First posted: 2024-03-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm randomised control trial
Primary purpose: BASIC_SCIENCE

Brief summary: The Academic Department of Military Rehabilitation (ADMR) is currently conducting a pan-defence, randomised control trial (RCT) investigating the utility of twice daily blood flow restriction training in UK military personnel with persistent knee pain (NCT05719922). Due to logistical confinements, this pan-defence RCT is confined to collecting outcome data pre and post-intervention. Therefore, the acute physiological mechanisms which underpin adaptation will remain unknown.

Consequently, ADMR is undertaking an additional, single centre RCT which will compare the acute physiological responses to low load resistance training with and without the addition of blood flow restriction. Specifically, this study will elucidate the effect of twice daily blood flow restriction training on measures of muscle swelling, muscle damage and inflammation. This data may aid in the optimisation of blood flow restriction exercise prescription within UK Defence Rehabilitation and elsewhere.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 55 years
* Must not have performed regular lower-limb resistance training for the last 6 months (participants must have performed \< 1 lower-limb resistance training session per week over the previous 6 months)
* DMRC Staff member (civilian or service personnel)

Exclusion Criteria:

* Any medical contraindication related to BFR\*.
* Any current lower-limb musculoskeletal injury
* Restricted range of movement. i.e. Chronically locked knee or fixed flexion deformity.
* Any physical impairment or co-morbidities (including cardio-vascular disease) precluding the safe participation in the intervention and/or assessment procedures
* Non-musculoskeletal or serious pathological condition (i.e. Inflammatory arthropathy, infection or tumour).
* Use of any medication which may contraindicate the performance of BFR or influence blood biomarkers of EIMD or inflammation.
* Use of any performance enhancing supplements or ergogenic aids such as creatine monohydrate.
* Any individual who is known to be currently pregnant

  \*Medical-based Exclusion Criteria (based on clinical contraindications to performing BFR):
* History of cardiovascular disease (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 (tourniquet raises intra-compartmental muscle pressure).
* 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
* Increased risk of haemorrhagic stroke, exercise induced rhabdomyolysis.

Primary outcomes:
measure: Maximum isometric voluntary contraction of knee extensor muscles
timeFrame: Measures collected in the morning on day 1,2,3,4,5,8. Measures also performed immediately before and 30 seconds after exercise on day 1 and 4
Secondary outcomes:
measure: Vastus lateralis muscle thickness
timeFrame: Measures collected in the morning on day 1,2,3,4,5,8. Measures also performed before, 3 min after and 4 hours after exercise on day 1 and 4
measure: Venous blood sampling for markers of exercise induced muscle damage
timeFrame: Measures collected in the morning on day 1,2,4,5,8. Measures also performed before, 10 min after and 4 hours after exercise on day 1
measure: Delayed onset muscle soreness
timeFrame: Measures collected in the morning on day 1,2,3,4,5,8
measure: Quadriceps discomfort
timeFrame: Measured immediately after each exercise session
measure: Discomfort caused by the BFR cuff
timeFrame: Measured immediately after each exercise session
measure: Rating of perceived exertion
timeFrame: Measured immediately after each exercise session
measure: Knee joint range of motion
timeFrame: Measures collected in the morning on day 1,2,3,4,5,8
measure: Daily wellness questionnaire
timeFrame: Measures collected in the morning on day 1,2,3,4,5,8
measure: Venous blood sampling for inflammatory markers
timeFrame: Measures collected in the morning on day 1,2,4,5,8. Measures also performed before, 10 min after and 4 hours after exercise on day 1
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Defence Medical Rehabilitation Centre
Study officials:
affiliation: Defence Medical Rehabilitation Centre
name: Alexander Bennett, PhD
role: STUDY_CHAIR
References: