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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04606654
Other study ID # REC/788 Arva Naeem
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date February 5, 2021

Study information

Verified date February 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study Investigator will determine the effects of blood flow restriction training on hand grip strength using hand held dynamometer among healthy young adults and investigator also see effects of blood flow restriction training on forearm circumference using weighted measuring tape among healthy young adults along with correlation of male and female population following blood flow restriction training among healthy young adults.


Description:

(A randomized control trial will be conducted in Foundation University Institute of Rehabilitation Sciences on 56 healthy young adults. Study will be conducted in 6 months (May 2020 to December 2020). Healthy young adults of both genders between 20-40 years of age will be included in the study. Adults with any diagnosed cardiovascular, metabolic, orthopedic or neurological disease, active/ongoing infection, recent history of upper extremity fracture or history of vascular medication will not be included in this study. The outcome variables will be hand grip strength measured through hydraulic hand held dynamometer and forearm circumference through anthropometric measuring tape.After assessment and screening, subjects will be randomly allocated in Control group "A" receiving low intensity strength training and Interventional group "B" receiving blood flow restriction training along with low intensity strength training via lottery method.Each participant will receive three sessions per week for two consecutive weeks making 6 treatment sessions in total. The outcome variables will be assessed at the start of 1st session and then at 6th session. To carry out the anthropometric assessment, anthropometric tape for circumference measurements, a digital scale for measuring weight and a stadiometer to measure height will be used.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date February 5, 2021
Est. primary completion date February 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Healthy adults of sedentary lifestyle - Young healthy adults following 6 minutes' Walk test - Young healthy adults following YMCA 3 minutes Step test Exclusion Criteria: - Any diagnosed cardiovascular, metabolic, orthopaedic or neurological disease - Active/ongoing infection - Recent history of upper extremity fracture - History of vascular medication

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Handgrip strength training without Blood flow restriction
Participants of this group will get exercise training through hand grip strengthener and DMOOSE fitness resistance bar. Participants will contract his/her forearm at a rate of 15 times/min (1 contraction every 4 sec). The subjects will train for 20 min, 3 days per week for 2 weeks (total 6 sessions), under the supervision of a principle investigator. Participants will be allowed to take 1 min rest periods, after the completion of 5 minutes of training.
Handgrip strength training with Blood flow restriction
Participants of this group will get exercise training through hand grip strengthener and DMOOSE fitness resistance bar. Participants will contracts his/her forearm at a rate of 15 times/min (1 contraction every 4 sec). The subjects will train for 20 min, 3 days per week for 2 weeks (total 6 sessions), under the supervision of a principle investigator. Participants will be allowed to take 1 min rest periods, after the completion of 5 minutes of training. However, for one of the limbs the pneumatic blood pressure cuff will be placed on the upper arm, 4 cm proximal to the ante-cubital fossa. The decision which arm would receive the occlusion during training will be randomized to avoid a dominant or non-dominant hand bias. During experimental group training blood pressure cuff will be partially inflated (80 mmHg) to ensure venous occlusion. Participants will be allowed to take 1 min rest periods, after the completion of 5 minutes of training while the cuff remained inflated.

Locations

Country Name City State
Pakistan Foundation University Institute of Rehabilitation Sciences Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (17)

Araújo JP, Silva ED, Silva JC, Souza TS, Lima EO, Guerra I, Sousa MS. The acute effect of resistance exercise with blood flow restriction with hemodynamic variables on hypertensive subjects. J Hum Kinet. 2014 Nov 12;43:79-85. doi: 10.2478/hukin-2014-0092. eCollection 2014 Sep 29. — View Citation

Bohannon RW, Bubela DJ, Wang YC, Magasi SS, Gershon RC. Six-Minute Walk Test Vs. Three-Minute Step Test for Measuring Functional Endurance. J Strength Cond Res. 2015 Nov;29(11):3240-4. doi: 10.1519/JSC.0000000000000253. — View Citation

Brandner CR, Kidgell DJ, Warmington SA. Unilateral bicep curl hemodynamics: Low-pressure continuous vs high-pressure intermittent blood flow restriction. Scand J Med Sci Sports. 2015 Dec;25(6):770-7. doi: 10.1111/sms.12297. Epub 2014 Jul 23. — View Citation

Cardoso RK, Araujo AM, Del Vechio FB, Bohlke M, Barcellos FC, Oses JP, de Freitas MP, Rombaldi AJ. Intradialytic exercise with blood flow restriction is more effective than conventional exercise in improving walking endurance in hemodialysis patients: a randomized controlled trial. Clin Rehabil. 2020 Jan;34(1):91-98. doi: 10.1177/0269215519880235. Epub 2019 Oct 11. — View Citation

Centner C, Wiegel P, Gollhofer A, König D. Correction to: Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):109-111. doi: 10.1007/s40279-018-1013-2. — View Citation

Credeur DP, Hollis BC, Welsch MA. Effects of handgrip training with venous restriction on brachial artery vasodilation. Med Sci Sports Exerc. 2010 Jul;42(7):1296-302. doi: 10.1249/MSS.0b013e3181ca7b06. — View Citation

Cristina-Oliveira M, Meireles K, Spranger MD, O'Leary DS, Roschel H, Peçanha T. Clinical safety of blood flow-restricted training? A comprehensive review of altered muscle metaboreflex in cardiovascular disease during ischemic exercise. Am J Physiol Heart Circ Physiol. 2020 Jan 1;318(1):H90-H109. doi: 10.1152/ajpheart.00468.2019. Epub 2019 Nov 8. Review. — View Citation

https://www.sralab.org/. 6 Minute Walk Test. 2020 2020 [cited 2020; Available from: https://www.sralab.org/rehabilitation-measures/6-minute-walk-test.

Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4. Review. — View Citation

Jacobson, J., et al., Blood Flow Restriction Training in Clinical Musculoskeletal Rehabilitation: A Critically Appraised Paper. International Journal of Athletic Therapy and Training, 2020. 1(aop): p. 1-4.

Jessee MB, Dankel SJ, Buckner SL, Mouser JG, Mattocks KT, Loenneke JP. The Cardiovascular and Perceptual Response to Very Low Load Blood Flow Restricted Exercise. Int J Sports Med. 2017 Jul;38(8):597-603. doi: 10.1055/s-0043-109555. Epub 2017 Jun 26. — View Citation

Lixandrão ME, Ugrinowitsch C, Berton R, Vechin FC, Conceição MS, Damas F, Libardi CA, Roschel H. Magnitude of Muscle Strength and Mass Adaptations Between High-Load Resistance Training Versus Low-Load Resistance Training Associated with Blood-Flow Restriction: A Systematic Review and Meta-Analysis. Sports Med. 2018 Feb;48(2):361-378. doi: 10.1007/s40279-017-0795-y. Review. — View Citation

O'Brien, L. Blood Flow Restriction Therapy. 2020 [cited 2020; Available from: https://members.physio-pedia.com/learn/blood-flow-restriction-therapy/.

Pearson SJ, Hussain SR. A review on the mechanisms of blood-flow restriction resistance training-induced muscle hypertrophy. Sports Med. 2015 Feb;45(2):187-200. doi: 10.1007/s40279-014-0264-9. Review. — View Citation

Pope ZK, Willardson JM, Schoenfeld BJ. Exercise and blood flow restriction. J Strength Cond Res. 2013 Oct;27(10):2914-26. doi: 10.1519/JSC.0b013e3182874721. Review. — View Citation

Sato, Y., The history and future of KAATSU training. International Journal of KAATSU Training Research, 2005. 1(1): p. 1-5.

Yasuda, T., et al., Use and safety of KAATSU training: Results of a national survey in 2016. International Journal of KAATSU Training Research, 2017. 13(1): p. 1-9.

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Hand grip strength Changes from the baseline, To measure hand grip strength through Hydraulic Hand held Dynamo-meter. It will be measured in pounds 8 weeks
Primary Forearm circumference After strength training forearm circumference through anthropometric measuring tape will be measured in inches by inches measuring tape. 8 weeks
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