Sports Physical TherapyNCT04606654
Handgrip Training With and Without Blood Flow Restriction in Relation to Gender Among Healthy Young Adults
A study testing Handgrip strength training without Blood flow restriction and Handgrip strength training with Blood flow restriction in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Handgrip strength training without Blood flow restriction and Handgrip strength training with Blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2020to 5 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults of sedentary lifestyle
- Young healthy adults following 6 minutes' Walk test
- Young healthy adults following YMCA 3 minutes Step test
Who cannot join
- Any diagnosed cardiovascular, metabolic, orthopaedic or neurological disease
- Active/ongoing infection
- Recent history of upper extremity fracture
- History of vascular medication
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University Institute of Rehabilitation Sciences
Rawalpindi, Punjab Province, 44000
About this study
Official title: 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.
Read the 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.
- Conditions
- Sports Physical Therapy
- Being tested
- Handgrip strength training without Blood flow restriction, Handgrip strength training with Blood flow restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip strength training without Blood flow restrictionOther
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 restrictionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Handgrip strength training without Blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Changes from the baseline, To measure hand grip strength through Hydraulic Hand held Dynamo-meter. It will be measured in pounds
Measured: 8 weeks
Forearm circumference
After strength training forearm circumference through anthropometric measuring tape will be measured in inches by inches measuring tape.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Aug 2020
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suhail Karim, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606654
- Sponsor's protocol ID
- REC/788 Arva Naeem
- Status last verified
- Feb 2021
- First submitted
- 22 Oct 2020
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28259850Lixandrao 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.
PubMed 29043659Cristina-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.
PubMed 31702969Pearson 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.
PubMed 25249278Sato, 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.
PubMed 31603002Jessee 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.
PubMed 28651256Brandner 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.
PubMed 25055880Araujo 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.
PubMed 25713647Centner 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.
PubMed 30414044Jacobson, 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.
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.
PubMed 23364292Credeur 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.
PubMed 20019641
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Handgrip Training With and Without Blood Flow Restriction in Relation to Gender Among Healthy Young Adults
- ClinicalTrials.gov ID
- NCT04606654
- Acronym / sponsor ID
- REC/788 Arva Naeem
- Conditions
- Sports Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Handgrip strength training with Blood flow restriction | Experimental | Other: Handgrip strength training with Blood flow restrictionThree 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 |
| Handgrip strength training without Blood flow restriction | Active comparator | Other: Handgrip strength training without Blood flow restrictionThree 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults of sedentary lifestyle
- Young healthy adults following 6 minutes' Walk test
- Young healthy adults following YMCA 3 minutes Step test
Key exclusion criteria (4 listed)
- Any diagnosed cardiovascular, metabolic, orthopaedic or neurological disease
- Active/ongoing infection
- Recent history of upper extremity fracture
- History of vascular medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handgrip strength training without Blood flow restrictionParticipants 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. | Other | Handgrip strength training without Blood flow restriction |
| Handgrip strength training with Blood flow restrictionParticipants 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. | Other | Handgrip strength training with Blood flow restriction |
Primary outcome
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
Forearm circumference
Time frame: 8 weeks
After strength training forearm circumference through anthropometric measuring tape will be measured in inches by inches measuring tape.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Background: PubMed 28259850Hughes 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.
- Background: PubMed 29043659Lixandrao 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.
- Background: PubMed 31702969Cristina-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.
- Background: PubMed 25249278Pearson 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.
- BackgroundSato, Y., The history and future of KAATSU training. International Journal of KAATSU Training Research, 2005. 1(1): p. 1-5.
- BackgroundYasuda, 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.
- BackgroundO'Brien, L. Blood Flow Restriction Therapy. 2020 [cited 2020; Available from: https://members.physio-pedia.com/learn/blood-flow-restriction-therapy/.
- Background: PubMed 31603002Cardoso 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.
- Background: PubMed 28651256Jessee 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.
- Background: PubMed 25055880Brandner 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.
- Background: PubMed 25713647Araujo 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.
- Background: PubMed 30414044Centner 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.
- Individual participant dataSharing planned: No
Related trials for Sports Physical Therapy
Recruiting
Effects of Scapular Training on Adolescent Boxers
Sports Physical Therapy
Recruiting
Comparative Effects of Dolphin Kick Streamline Training Versus Flutter Kick Training in Competitive Swimmers
Sports Physical Therapy
Not yet recruiting
Effects of Explosive Plyometric Training Versus Thera-Band Power Training on Sprint Swimming Performance
Sports Physical Therapy
Not yet recruiting
Comparative Effects of Spencer Muscle Energy Technique Versus Post Facilitation Stretch Among Fast Bowlers
Sports Physical Therapy
Recruiting
Core Training in Amateur Soccer Players
Sports Physical Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suhail Karim, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handgrip strength training without Blood flow restriction and Handgrip strength training with Blood flow restriction in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strength (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606654, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.