Skip to main content
Clinical Trials/NCT06334224
NCT06334224UnknownNot Applicable

Effects of Twice Daily Blood Flow Restriction Training on Muscle Swelling, Markers of Exercise Induced Muscle Damage and Inflammation: A Randomised Control Trial

Defence Medical Rehabilitation Centre, UK2 sites in 1 country18 target enrollmentStarted: November 6, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
18
Locations
2
Primary Endpoint
Maximum isometric voluntary contraction of knee extensor muscles

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Masking Description

Due to the nature of the intervention, it is not possible to blind participants or outcome assessors to the treatment allocation. There is also no effective sham condition available. This is a common limitation within all blood flow restriction training research.

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Maximum isometric voluntary contraction of knee extensor muscles

Time Frame: 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

Measured using an isokinetic dynamometer

Secondary Outcomes

  • Quadriceps discomfort(Measured immediately after each exercise session)
  • Venous blood sampling for markers of exercise induced muscle damage(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)
  • Discomfort caused by the BFR cuff(Measured immediately after each exercise session)
  • Rating of perceived exertion(Measured immediately after each exercise session)
  • Delayed onset muscle soreness(Measures collected in the morning on day 1,2,3,4,5,8)
  • Daily wellness questionnaire(Measures collected in the morning on day 1,2,3,4,5,8)
  • Vastus lateralis muscle thickness(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)
  • Knee joint range of motion(Measures collected in the morning on day 1,2,3,4,5,8)
  • Venous blood sampling for inflammatory markers(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)

Investigators

Sponsor
Defence Medical Rehabilitation Centre, UK
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Peter Ladlow

Higher Scientific Officer and Chief Investigator

Defence Medical Rehabilitation Centre, UK

Study Sites (2)

Loading locations...

Similar Trials