Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06334224
Other study ID # 2242/MODREC/23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT04207359 - Effects of Creatine Supplementation in Breast Cancer Survivors N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04076982 - Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians N/A
Not yet recruiting NCT03662555 - Effect of Neuromuscular Electrical Stimulation Combined With Blood Flow Restriction on Muscular and Cardiovascular Function N/A
Completed NCT02530723 - Functional Changes and Power Training in Older Women. N/A
Completed NCT01743495 - CAPABLE for Frail Dually Eligible Older Adults N/A
Completed NCT01704976 - SR-WBV Training for Frail Elderly in the Skilling up Stage N/A
Completed NCT00183040 - HORMA: Hormonal Regulators of Muscle and Metabolism in Aging Phase 2
Enrolling by invitation NCT06432062 - Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia
Recruiting NCT05073224 - Muscle Function After Childbirth N/A
Completed NCT04956705 - Vitamin D and Calcium Supplementation at Danish Nursing Homes N/A
Recruiting NCT03810768 - Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
Completed NCT00060970 - Evaluating Muscle Function After Ankle Surgery N/A
Completed NCT04546048 - The Early Strength Training Program in Post-transplant Liver Cases N/A
Completed NCT03628365 - Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients? N/A
Completed NCT05056298 - Effect of Insole Added to Exercise in Patients With Bilateral Flexible Flatfoot N/A
Completed NCT02739464 - Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients N/A
Completed NCT05497960 - Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes N/A