Acute Physiological Responses to Twice Daily Blood Flow Restriction Training

NCT ID: NCT06334224

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Muscle Weakness Muscle Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arm randomised control trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

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.

Study Groups

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Low-load resistance training

Twice-daily low load resistance training for four days

Group Type ACTIVE_COMPARATOR

Low load resistance training

Intervention Type OTHER

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

Blood flow restriction training

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

Group Type EXPERIMENTAL

Low load resistance training with blood flow restriction

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Low load resistance training

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bath

OTHER

Sponsor Role collaborator

Defence Medical Rehabilitation Centre, UK

OTHER_GOV

Sponsor Role lead

Responsible Party

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Peter Ladlow

Higher Scientific Officer and Chief Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Bennett, PhD

Role: STUDY_CHAIR

Defence Medical Rehabilitation Centre

Locations

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Defence Medical Rehabilitation Centre

Loughborough, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Peter Ladlow, PhD

Role: CONTACT

+44 (0)1509 251 500 ext. 3407

Russ Coppack, PhD

Role: CONTACT

+44 (0)1509 251 500 ext. 4418

Facility Contacts

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Kieran M Lunt, MSc

Role: primary

+44(0) 1509 251 500 ext. 3401

Peter Ladlow, PhD

Role: backup

+44(0) 1509 251 500 ext. 3407

Other Identifiers

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2242/MODREC/23

Identifier Type: -

Identifier Source: org_study_id

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