Acute Physiological Responses to Twice Daily Blood Flow Restriction Training

NCT06334224 | Recruiting

• 1 other identifier: 2242/MODREC/23
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness; Muscle Damage

Keywords

resistance training; blood flow restriction; exercise induced muscle damage; muscle swelling; occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

• Delayed onset muscle soreness

  Measures collected in the morning on day 1,2,3,4,5,8

• Quadriceps discomfort

  Measured immediately after each exercise session

• Discomfort caused by the BFR cuff

  Measured immediately after each exercise session

Study Arms (2)

Low-load resistance training

ACTIVE COMPARATOR

Twice-daily low load resistance training for four days

Other: Low load resistance training

Blood flow restriction training

EXPERIMENTAL

Twice-daily low load resistance training with blood flow restriction for four days

Device: Low load resistance training with blood flow restriction

Interventions

Low load resistance training with blood flow restriction DEVICE

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.

Blood flow restriction training

Low load resistance training OTHER

Leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum.

Low-load resistance training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Defence Medical Rehabilitation Centre, UK: lead
• University of Bath: collaborator

Study Sites (1)

Defence Medical Rehabilitation Centre

Loughborough, LE12 5QW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Muscle Weakness; Bites and Stings

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Alexander Bennett, PhD

  Defence Medical Rehabilitation Centre

  STUDY CHAIR

Central Study Contacts

Peter Ladlow, PhD

CONTACT

+44 (0)1509 251 500; peter.ladlow100@mod.gov.uk

Russ Coppack, PhD

CONTACT

+44 (0)1509 251 500; Russ.Coppack100@mod.gov.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Higher Scientific Officer and Chief Investigator

Model Details: Two arm randomised control trial

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 27, 2024
• Study Start: November 6, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon completion of the dissemination of research findings (i.e., publications and conference proceedings)
• Access Criteria: Most data will be openly available, but due to privacy concerns, some data regarding participants are available only to bona fide researchers working on a related project, subject to the completion of a non-disclosure agreement

Locations

GB (1)