NCT04606654

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

October 22, 2020

Last Update Submit

February 5, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Forearm circumference

    After strength training forearm circumference through anthropometric measuring tape will be measured in inches by inches measuring tape.

    8 weeks

Study Arms (2)

Handgrip strength training with Blood flow restriction

EXPERIMENTAL

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; * Hand grip strength * Forearm circumference

Other: Handgrip strength training with Blood flow restriction

Handgrip strength training without Blood flow restriction

ACTIVE COMPARATOR

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; * Hand grip strength * Forearm circumference

Other: Handgrip strength training without Blood flow restriction

Interventions

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 without 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.

Handgrip strength training with Blood flow restriction

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults of sedentary lifestyle
  • Young healthy adults following 6 minutes' Walk test
  • Young healthy adults following YMCA 3 minutes Step test

You may not qualify if:

  • Any diagnosed cardiovascular, metabolic, orthopaedic or neurological disease
  • Active/ongoing infection
  • Recent history of upper extremity fracture
  • History of vascular medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (17)

  • 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.

    PMID: 28259850BACKGROUND
  • 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.

    PMID: 29043659BACKGROUND
  • 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.

    PMID: 31702969BACKGROUND
  • 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.

    PMID: 25249278BACKGROUND
  • Sato, Y., The history and future of KAATSU training. International Journal of KAATSU Training Research, 2005. 1(1): p. 1-5.

    BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 31603002BACKGROUND
  • 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.

    PMID: 28651256BACKGROUND
  • 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.

    PMID: 25055880BACKGROUND
  • 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.

    PMID: 25713647BACKGROUND
  • 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.

    PMID: 30414044BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 23364292BACKGROUND
  • 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.

    PMID: 20019641BACKGROUND
  • https://www.sralab.org/. 6 Minute Walk Test. 2020 2020 [cited 2020; Available from: https://www.sralab.org/rehabilitation-measures/6-minute-walk-test.

    BACKGROUND
  • 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.

    PMID: 24077375BACKGROUND

Study Officials

  • Suhail Karim, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 28, 2020

Study Start

August 1, 2020

Primary Completion

February 5, 2021

Study Completion

February 5, 2021

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations