Muscle WeaknessNCT06334224
Acute Physiological Responses to Twice Daily Blood Flow Restriction Training
A study testing Low load resistance training with blood flow restriction and Low load resistance training in people with Muscle Weakness and Muscle Damage, run by Defence Medical Rehabilitation Centre, UK at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness, Muscle Damage
- What is being tested?
- Low load resistance training with blood flow restriction and Low load resistance training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Defence Medical Rehabilitation Centre
Loughborough, LE12 5QW
Kieran M Lunt, MSc, +44(0) 1509 251 500 ext. 3401, kieran.lunt103@mod.gov.uk
Peter Ladlow, PhD, +44(0) 1509 251 500 ext. 3407, peter.ladlow100@mod.gov.uk
About this study
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
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
- Being tested
- Low load resistance training with blood flow restriction, Low load resistance training
- Keywords
- resistance training, blood flow restriction, exercise induced muscle damage, muscle swelling, occlusion
- Medical subject headings
- Muscle Weakness, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low load resistance training with blood flow restrictionDevice
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.
Low load resistance trainingOther
Leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum.
| Study group | Role | What they receive |
|---|---|---|
| Low-load resistance training | Active comparator | Twice-daily low load resistance training for four days Receives: Other: Low load resistance training |
| Blood flow restriction training | Experimental | Twice-daily low load resistance training with blood flow restriction for four days Receives: Device: Low load resistance training with blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum isometric voluntary contraction of knee extensor muscles
Measured using an isokinetic dynamometer
Measured: 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
Measured using B-Mode ultrasound
Measured: 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
Venous blood samples to measure markers of exercise induced muscle damage. E.g., Creatine Kinase (units/L)
Measured: 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
Measured using a 100 mm visual analog scale. A higher score indicates greater levels of muscle soreness.
Measured: Measures collected in the morning on day 1,2,3,4,5,8
Quadriceps discomfort
Measured immediately after each exercise session using a 100 mm visual analog scale. A higher score indicates greater levels of discomfort.
Measured: Measured immediately after each exercise session
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: Measured immediately after each exercise session
Rating of perceived exertion
Measured using a Borg 0-10 rating of perceived exertion scale. A higher score represents greater levels of exertion.
Measured: Measured immediately after each exercise session
Knee joint range of motion
measured using a goniometer
Measured: Measures collected in the morning on day 1,2,3,4,5,8
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.
Measured: Measures collected in the morning on day 1,2,3,4,5,8
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start6 Nov 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm randomised control trial
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Defence Medical Rehabilitation Centre, UK
- Sponsor type
- Other government
- Collaborators
- University of Bath
- Responsible party
- Principal investigator, Peter Ladlow, Defence Medical Rehabilitation Centre, UK
- Investigators
- Alexander Bennett, PhD, Study chair, Defence Medical Rehabilitation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334224
- Sponsor's protocol ID
- 2242/MODREC/23
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised participant data will be made available upon reasonable request to the chief investigator
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06334224
- Acronym / sponsor ID
- 2242/MODREC/23
- Conditions
- Muscle Weakness, Muscle Damage
- Keywords
- resistance training, blood flow restriction, exercise induced muscle damage, muscle swelling, occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Defence Medical Rehabilitation Centre, UKOther government
- Collaborators
- University of Bath
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Low-load resistance training | Active comparator | Other: Low load resistance trainingTwice-daily low load resistance training for four days |
| Blood flow restriction training | Experimental | Device: Low load resistance training with blood flow restrictionTwice-daily low load resistance training with blood flow restriction for four days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low load resistance training with blood flow restrictionThe 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. | Device | Blood flow restriction training |
| Low load resistance trainingLeg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum. | Other | Low-load resistance training |
Primary outcome
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
9 secondary outcomes
Vastus lateralis muscle thickness
Time frame: 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
Time frame: 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
Time frame: Measures collected in the morning on day 1,2,3,4,5,8
Quadriceps discomfort
Time frame: Measured immediately after each exercise session
Discomfort caused by the BFR cuff
Time frame: Measured immediately after each exercise session
Rating of perceived exertion
Time frame: Measured immediately after each exercise session
Knee joint range of motion
Time frame: Measures collected in the morning on day 1,2,3,4,5,8
Daily wellness questionnaire
Time frame: Measures collected in the morning on day 1,2,3,4,5,8
Venous blood sampling for inflammatory markers
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: Yes. Anonymised participant data will be made available upon reasonable request to the chief investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Bennett, PhD study chair
Defence Medical Rehabilitation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low load resistance training with blood flow restriction and Low load resistance training in people with Muscle Weakness and Muscle Damage, run by Defence Medical Rehabilitation Centre, UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Ladlow, PhD (+44 (0)1509 251 500 ext. 3407, peter.ladlow100@mod.gov.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.