Acute Physiological Responses to Twice Daily Blood Flow Restriction Training

Muscle Weakness Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334224
• Other study ID #: 2242/MODREC/23
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Defence Medical Rehabilitation Centre, UK
• Contact: Peter Ladlow, PhD
• Phone: +44 (0)1509 251 500
• Email: peter.ladlow100[@]mod.gov.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Damage
• Muscle Weakness

Intervention

Device:
• Low load resistance training with blood flow restriction
The intervention involves placing a pneumatic tourniquet system over the proximal thigh. The cuff is inflated to 80% of limb occlusion pressure during lower limb strengthening exercises. These exercises include leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum.

Other:
• Low load resistance training
Leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum.

Locations

Country	Name	City	State
United Kingdom	Defence Medical Rehabilitation Centre	Loughborough

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	Maximum isometric voluntary contraction of knee extensor muscles	Measured using an isokinetic dynamometer	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	Vastus lateralis muscle thickness	Measured using B-Mode ultrasound	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
Secondary	Venous blood sampling for markers of exercise induced muscle damage	Venous blood samples to measure markers of exercise induced muscle damage. E.g., Creatine Kinase (units/L)	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
Secondary	Delayed onset muscle soreness	Measured using a 100 mm visual analog scale. A higher score indicates greater levels of muscle soreness.	Measures collected in the morning on day 1,2,3,4,5,8
Secondary	Quadriceps discomfort	Measured immediately after each exercise session using a 100 mm visual analog scale. A higher score indicates greater levels of discomfort.	Measured immediately after each exercise session
Secondary	Discomfort caused by the BFR cuff	Measured in the intervention group immediately after each exercise session using a 100 mm visual analog scale. A higher score indicates greater levels of discomfort.	Measured immediately after each exercise session
Secondary	Rating of perceived exertion	Measured using a Borg 0-10 rating of perceived exertion scale. A higher score represents greater levels of exertion.	Measured immediately after each exercise session
Secondary	Knee joint range of motion	measured using a goniometer	Measures collected in the morning on day 1,2,3,4,5,8
Secondary	Daily wellness questionnaire	UK Defence Rehabilitation daily wellness questionnaire. This questionnaire asks participants to rate their: fatigue, muscle soreness, sleep quality, stress levels and mood on a 1-5 Likert scale.	Measures collected in the morning on day 1,2,3,4,5,8
Secondary	Venous blood sampling for inflammatory markers	Venous blood samples to measure markers of inflammation. E.g., Interleukin-6 (pg/ml), Tumour necrosis factor alpha (pg/mL) and vascular endothelial growth factor (pg/mL).	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