跳至主要内容
临床试验/NCT06334224
NCT06334224Unknown不适用

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 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年11月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
18
试验地点
2
主要终点
Maximum isometric voluntary contraction of knee extensor muscles

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

结局指标

主要结局

Maximum isometric voluntary contraction of knee extensor muscles

时间窗: 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

次要结局

  • 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)

研究者

发起方
Defence Medical Rehabilitation Centre, UK
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Peter Ladlow

Higher Scientific Officer and Chief Investigator

Defence Medical Rehabilitation Centre, UK

研究点 (2)

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