- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04606654
Handgrip Training With and Without Blood Flow Restriction in Relation to Gender Among Healthy Young Adults
February 5, 2021 updated by: Riphah International University
Effects of Handgrip Training With and Without Blood Flow Restriction in Relation to Gender Among Healthy Young Adults
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 44000
- Foundation university institute of rehabilitation sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Handgrip strength training with Blood flow restriction
Three sessions per week will be given to individual subject. and training will be with Blood flow restriction. Subjects will be followed for two weeks for;
|
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.
|
Active Comparator: Handgrip strength training without Blood flow restriction
Three sessions per week will be given to individual subject and training will be without Blood flow restriction. Subjects will be followed for two weeks for;
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hand grip strength
Time Frame: 8 weeks
|
Changes from the baseline, To measure hand grip strength through Hydraulic Hand held Dynamo-meter.
It will be measured in pounds
|
8 weeks
|
Forearm circumference
Time Frame: 8 weeks
|
After strength training forearm circumference through anthropometric measuring tape will be measured in inches by inches measuring tape.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suhail Karim, PP-DPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Lixandrao ME, Ugrinowitsch C, Berton R, Vechin FC, Conceicao 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.
- Cristina-Oliveira M, Meireles K, Spranger MD, O'Leary DS, Roschel H, Pecanha 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.
- 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.
- 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.
- O'Brien, L. Blood Flow Restriction Therapy. 2020 [cited 2020; Available from: https://members.physio-pedia.com/learn/blood-flow-restriction-therapy/.
- 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.
- 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.
- 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.
- Araujo 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.
- Centner C, Wiegel P, Gollhofer A, Konig 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.
- 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.
- 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.
- https://www.sralab.org/. 6 Minute Walk Test. 2020 2020 [cited 2020; Available from: https://www.sralab.org/rehabilitation-measures/6-minute-walk-test.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
February 5, 2021
Study Completion (Actual)
February 5, 2021
Study Registration Dates
First Submitted
October 22, 2020
First Submitted That Met QC Criteria
October 22, 2020
First Posted (Actual)
October 28, 2020
Study Record Updates
Last Update Posted (Actual)
February 8, 2021
Last Update Submitted That Met QC Criteria
February 5, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- REC/788 Arva Naeem
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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