The Short-term Effect of Low-load Resistance Training with Blood-flow Restriction on Somatosensory-evoked Potentials in Healthy Young Adults
NCT ID: NCT06762912
Last Updated: 2025-01-08
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-01-20
2025-07-31
Brief Summary
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* Is there an effect of short-term application of BFRT on the somatosensory system?
* How do different cuff widths affect the somatosensory system?
* How do three different cuff widths affect perceived pain? Researchers will compare 3 different cuff widths to see if different cuff widths affect the somatosensory system and perceived pain.
Participants will:
* Undergo 3 experimental sessions, sessions will be separated by 72 hours and the order of the sessions to be randomly selected.
* Perform low-load resistance training with blood flow restriction.
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Detailed Description
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Healthy young adults aged 18-30 years of both genders will be recruited through word of mouth and through social media by sharing the study flyer. Then, they will be screened for their eligibility to participate in the current study. Participants who will meet the eligibility criteria will be asked to provide their consent after the study is explained by filling out the consent form.
Participants will be randomly assigned to one of the three groups: (1) small cuff width (5 cm), (2) medium cuff width (12 cm), and (3) large cuff width (18 cm) by using permuted block randomization method with large, random, and variable block sizes to ensure groups are balanced and selection bias is minimized.
The first experimental session will start by conducting the one repetition maximum (1-RM) test of unilateral knee extension of the dominant leg, in which the dominant side was identified by asking the participants which side they will use to kick a ball. Before conducting the 1-RM test, 5 minutes warm-up on the cycle ergometer at 75W will be done. Calibration of the dynamometer will be done before operating the machine with each participant, then the participant will be positioned on the dynamometer seat comfortably with ensuring the back is supported and the knee is aligned with the axis of rotation. The participant will be asked to complete one successful repetition of knee extension through full range of motion (ROM), with increasing load until the participant can no longer complete full knee extension ROM, 3 minutes of rest will be allowed between attempts until the 1-RM is identified. To eliminate the effect of fatigue after 1-RM test, the first experimental session will always include the application of the BFR cuff without resistance exercise.
For both experimental sessions 2 and 3, the order of exercise condition will be randomly selected, either to be (1) the application of BFR cuff with resistance exercise, or (2) resistance exercise without the application of BFR cuff to decrease the incidence of learning effect. Cuff pressure during the application of BFR will be standardized to 50% of AOP.
The resistance exercise for both experimental sessions 2 and 3 will be exactly similar and will involve four sets of isometric knee extensions at an intensity of 20% of 1-RM with repetitions of 30, 15, 15, and 15 by using the isokinetic dynamometer machine, which has a good to excellent test-retest reliability for knee extension movement with ICC value of 0.95-0.99. To minimize cognitive and neuromuscular fatigue, the experimental sessions will be separated by a minimum of three days (72 hours).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Passive application of BFR cuff
Passive application of BFR cuff
The first experimental session will start by conducting the one repetition maximum (1-RM) test of unilateral knee extension of the dominant leg, in which the dominant side was identified by asking the participants which side they will use to kick a ball. Before conducting the 1-RM test, 5 minutes warm-up on the cycle ergometer at 75W will be done. Calibration of the dynamometer will be done before operating the machine with each participant, then the participant will be positioned on the dynamometer seat comfortably with ensuring the back is supported and the knee is aligned with the axis of rotation. The participant will be asked to complete one successful repetition of knee extension through full range of motion (ROM), with increasing load until the participant can no longer complete full knee extension ROM, 3 minutes of rest will be allowed between attempts until the 1-RM is identified.
Resistance exercise with BFR
Resistance exercise with BFR
For both experimental sessions 2 and 3, the order of exercise condition will be randomly selected, either to be (1) the application of BFR cuff with resistance exercise, or (2) resistance exercise without the application of BFR cuff to decrease the incidence of learning effect. Cuff pressure during the application of BFR will be standardized to 50% of AOP.
The resistance exercise for both experimental sessions 2 and 3 will be exactly similar and will involve four sets of isometric knee extensions at an intensity of 20% of 1-RM with repetitions of 30, 15, 15, and 15 by using the isokinetic dynamometer machine, which has a good to excellent test-retest reliability for knee extension movement with ICC value of 0.95-0.99. To minimize cognitive and neuromuscular fatigue, the experimental sessions will be separated by a minimum of three days (72 hours).
Resistance exercise without BFR
Resistance exercise without BFR
For both experimental sessions 2 and 3, the order of exercise condition will be randomly selected, either to be (1) the application of BFR cuff with resistance exercise, or (2) resistance exercise without the application of BFR cuff to decrease the incidence of learning effect. Cuff pressure during the application of BFR will be standardized to 50% of AOP.
The resistance exercise for both experimental sessions 2 and 3 will be exactly similar and will involve four sets of isometric knee extensions at an intensity of 20% of 1-RM with repetitions of 30, 15, 15, and 15 by using the isokinetic dynamometer machine, which has a good to excellent test-retest reliability for knee extension movement with ICC value of 0.95-0.99. To minimize cognitive and neuromuscular fatigue, the experimental sessions will be separated by a minimum of three days (72 hours).
Interventions
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Passive application of BFR cuff
The first experimental session will start by conducting the one repetition maximum (1-RM) test of unilateral knee extension of the dominant leg, in which the dominant side was identified by asking the participants which side they will use to kick a ball. Before conducting the 1-RM test, 5 minutes warm-up on the cycle ergometer at 75W will be done. Calibration of the dynamometer will be done before operating the machine with each participant, then the participant will be positioned on the dynamometer seat comfortably with ensuring the back is supported and the knee is aligned with the axis of rotation. The participant will be asked to complete one successful repetition of knee extension through full range of motion (ROM), with increasing load until the participant can no longer complete full knee extension ROM, 3 minutes of rest will be allowed between attempts until the 1-RM is identified.
Resistance exercise with BFR
For both experimental sessions 2 and 3, the order of exercise condition will be randomly selected, either to be (1) the application of BFR cuff with resistance exercise, or (2) resistance exercise without the application of BFR cuff to decrease the incidence of learning effect. Cuff pressure during the application of BFR will be standardized to 50% of AOP.
The resistance exercise for both experimental sessions 2 and 3 will be exactly similar and will involve four sets of isometric knee extensions at an intensity of 20% of 1-RM with repetitions of 30, 15, 15, and 15 by using the isokinetic dynamometer machine, which has a good to excellent test-retest reliability for knee extension movement with ICC value of 0.95-0.99. To minimize cognitive and neuromuscular fatigue, the experimental sessions will be separated by a minimum of three days (72 hours).
Resistance exercise without BFR
For both experimental sessions 2 and 3, the order of exercise condition will be randomly selected, either to be (1) the application of BFR cuff with resistance exercise, or (2) resistance exercise without the application of BFR cuff to decrease the incidence of learning effect. Cuff pressure during the application of BFR will be standardized to 50% of AOP.
The resistance exercise for both experimental sessions 2 and 3 will be exactly similar and will involve four sets of isometric knee extensions at an intensity of 20% of 1-RM with repetitions of 30, 15, 15, and 15 by using the isokinetic dynamometer machine, which has a good to excellent test-retest reliability for knee extension movement with ICC value of 0.95-0.99. To minimize cognitive and neuromuscular fatigue, the experimental sessions will be separated by a minimum of three days (72 hours).
Eligibility Criteria
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Inclusion Criteria
* Participants will be included if they have a body mass index (BMI) less than 25 or non-overweight individuals.
* Use of the long international physical activity questionnaire (L-IPAQ) to ensure all participants have equal physical activity levels.
* Participants will be excluded if they were diagnosed with any neurological disease.
* Participants will be excluded if they have had any musculoskeletal injury in the past 3 months to avoid potential effect on their physical activity levels.
18 Years
30 Years
ALL
Yes
Sponsors
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University of Sharjah
OTHER
Responsible Party
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Taif A. M. Omran
Master's Student
Locations
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University of Sharjah
Sharjah city, , United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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References
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Yusof, N., (2019). Likert Scale vs. Visual analogue scale on vehicle seat discomfort questionnaire: a review. Malaysian Journal of Medicine and Health Sciences, 15(204).
Muzyka IM, Estephan B. Somatosensory evoked potentials. Handb Clin Neurol. 2019;160:523-540. doi: 10.1016/B978-0-444-64032-1.00035-7.
Li X, Li J, Qing L, Wang H, Ma H, Huang P. Effect of quadriceps training at different levels of blood flow restriction on quadriceps strength and thickness in the mid-term postoperative period after anterior cruciate ligament reconstruction: a randomized controlled external pilot study. BMC Musculoskelet Disord. 2023 May 8;24(1):360. doi: 10.1186/s12891-023-06483-x.
Wanner M, Probst-Hensch N, Kriemler S, Meier F, Autenrieth C, Martin BW. Validation of the long international physical activity questionnaire: Influence of age and language region. Prev Med Rep. 2016 Mar 9;3:250-6. doi: 10.1016/j.pmedr.2016.03.003. eCollection 2016 Jun.
Korakakis V, Whiteley R, Giakas G. Low load resistance training with blood flow restriction decreases anterior knee pain more than resistance training alone. A pilot randomised controlled trial. Phys Ther Sport. 2018 Nov;34:121-128. doi: 10.1016/j.ptsp.2018.09.007. Epub 2018 Sep 19.
Sousa J, Neto GR, Santos HH, Araujo JP, Silva HG, Cirilo-Sousa MS. Effects of strength training with blood flow restriction on torque, muscle activation and local muscular endurance in healthy subjects. Biol Sport. 2017 Mar;34(1):83-90. doi: 10.5114/biolsport.2017.63738. Epub 2016 Dec 1.
Shousha T, Alayat M, Moustafa I. Effects of low-level laser therapy versus soft occlusive splints on mouth opening and surface electromyography in females with temporomandibular dysfunction: A randomized-controlled study. PLoS One. 2021 Oct 1;16(10):e0258063. doi: 10.1371/journal.pone.0258063. eCollection 2021.
Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856. doi: 10.2147/JPR.S158847. eCollection 2018.
Cidem M, Sahin Z, Aydin T, Aysal F. Somatosensory evoked potential findings in ankylosing spondylitis. Eurasian J Med. 2014 Feb;46(1):42-6. doi: 10.5152/eajm.2013.100.
Tuominen J, Leppanen M, Jarske H, Pasanen K, Vasankari T, Parkkari J. Test-Retest Reliability of Isokinetic Ankle, Knee and Hip Strength in Physically Active Adults Using Biodex System 4 Pro. Methods Protoc. 2023 Mar 9;6(2):26. doi: 10.3390/mps6020026.
Maudrich T, Degener S, Ragert P, Kenville R. The impact of acute blood-flow-restriction resistance exercise on somatosensory-evoked potentials in healthy adults. Exp Physiol. 2024 Nov;109(11):1869-1881. doi: 10.1113/EP091911. Epub 2024 Sep 4.
Fatela P, Reis JF, Mendonca GV, Avela J, Mil-Homens P. Acute effects of exercise under different levels of blood-flow restriction on muscle activation and fatigue. Eur J Appl Physiol. 2016 May;116(5):985-95. doi: 10.1007/s00421-016-3359-1. Epub 2016 Mar 26.
Ilett MJ, Rantalainen T, Keske MA, May AK, Warmington SA. The Effects of Restriction Pressures on the Acute Responses to Blood Flow Restriction Exercise. Front Physiol. 2019 Aug 13;10:1018. doi: 10.3389/fphys.2019.01018. eCollection 2019.
van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017.
Carter, K., Scheffold, A. L., Renteria, J., Berger, V. W., Luo, Y. A., Chipman, J. J., & Sverdlov, O. (2024). Regulatory Guidance on Randomization and the Use of Randomization Tests in Clinical Trials: A Systematic Review. Statistics in Biopharmaceutical Research, 16(4), 428-440. https://doi.org/10.1080/19466315.2023.2239521
Broglio K. Randomization in Clinical Trials: Permuted Blocks and Stratification. JAMA. 2018 Jun 5;319(21):2223-2224. doi: 10.1001/jama.2018.6360. No abstract available.
Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.
Other Identifiers
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BFRT-SSEP
Identifier Type: -
Identifier Source: org_study_id
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