Resistance TrainingNCT06131047
High Intensity Resistance Training With and Without Blood Flow Restriction in ACL Reconstruction
A study testing High intensity Traditional Resistance Traning without Blood Flow Restriction and High intensity Traditional Resistance Traning with Blood Flow Restriction in people with Resistance Training and Blood Flow Restriction Therapy, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is randomized and single-blinded. Ethical approval is taken from the ethical committee of riphah international university, Lahore. Participants who meet the inclusion criteria will be enrolled in Groups A \& B through the sealed envelop method by the Non-Probability Convenient random sampling technique. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Resistance Training, Blood Flow Restriction Therapy, Anterior Cruciate Ligament Reconstruction
- What is being tested?
- High intensity Traditional Resistance Traning without Blood Flow Restriction and High intensity Traditional Resistance Traning with Blood Flow Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2023to 20 Feb 2024
- 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male players with age group 18 to 25 years,Return to function phase of rehabilitation,Players with Grade III ACL Tear ,Athletes who have been playing for at least 2 years
Who cannot join
- Players after ACL Reconstruction in acute or subacute phase,Players with other biomechanical issues of knee or feet,Players with any hematological disorders or hypertension
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ghurki Trust & Teaching Hospital
Lahore, Punjab Province, 543000
Hafiz Muhammad Asim, PhD, +923009400346, Dean.lcp@lmdc.edu.pk
Muhammad Nouman tabassum, DPT, +923336849593, nouman06@gmail.com
About this study
Official title: Effects of High Intensity Resistance Training With and Without Blood Flow Restriction on Quadriceps Strength, Power and Agility in ACL Reconstruction Among Volley Ball Players
This study is randomized and single-blinded. Ethical approval is taken from the ethical committee of riphah international university, Lahore. Participants who meet the inclusion criteria will be enrolled in Groups A \& B through the sealed envelop method by the Non-Probability Convenient random sampling technique. Group A will perform traditional High-intensity resistance training without Blood Flow Restriction training after ACL Reconstruction Surgery. Group B will perform traditional High-intensity Resistance training with Blood Flow Restriction training after ACL Reconstruction Surgery.
Read the detailed description
The objective of the study is to determine the effects of high-intensity resistance training with and without blood flow restriction on quadriceps strength, power, and agility after ACL reconstruction among volleyball players. This study is randomized and single-blinded. Ethical approval is taken from the ethical committee of riphah international university, Lahore. Participants who meet the inclusion criteria will be enrolled in Groups A \& B through the sealed envelop method by the Non-Probability Convenient random sampling technique. Group A will perform traditional High-intensity resistance training without Blood Flow Restriction training after ACL Reconstruction Surgery. Group B will perform traditional High-intensity Resistance training with Blood Flow Restriction training after ACL Reconstruction Surgery. The outcome measures will be assessed by hand held dynamometer.1-RM test, Illinois Agility Test, and Vertical jump test.
The data will be analyzed by SPSS,version 25.Statistical siginificance is P= 0.05.
- Conditions
- Resistance Training, Blood Flow Restriction Therapy, Anterior Cruciate Ligament Reconstruction, Volleyball
- Being tested
- High intensity Traditional Resistance Traning without Blood Flow Restriction, High intensity Traditional Resistance Traning with Blood Flow Restriction
- Keywords
- High intensity resistance training, Blood Flow Restriction Traning, ACL reconstruction, Volley ball Players
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity Traditional Resistance Traning without Blood Flow RestrictionOther
Group A will undergo Traditional Resistance training without blood flow Restriction. A 30-minute progressive, weight training program will be initiated 8 weeks after the ACL-reconstruction and will be conducted subsequent to the individual based program. The resistance (training loads) will be increased when the individual could do more repetitions than the number specified in the weight training protocol. The exercises will be performed at a slow speed to ensure full control of the movement
High intensity Traditional Resistance Traning with Blood Flow RestrictionOther
Group B will recieve low-load blood flow restriction (LL-BFR) training using external loads of 20-40% 1RM has been suggested as an alternative to traditional strength rehabilitation. Minimum of 2 -3 sets and maximum total 5 sets,20-30 repetitions of each exercise with 30 to 60 seconds rest period and 2-3 times per weekly for 4-6 weeks to During LL-BFR training, a pressurized cuff is applied to the proximal thigh that oc¬cludes venous outflow while maintaining arterial in¬flow. The combination of venous occlusion and resis¬tance training is believed to induce muscle hypertrophy secondary to elevated systematic hormone production, cell swelling, production of reactive oxygen species, intramus¬cular anabolic signaling and fast-twitch fiber recruit¬ment
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Traditional Resistance Training Group | Experimental | Group A will undergo Traditional Resistance training without blood flow Restriction. A 30-minute progressive, weight training program will be initiated 8 weeks after the ACL-reconstruction and will be conducted subsequent to the individual based program. The resistance (training loads) will be increased when the individual could do more repetitions than the number specified in the weight training protocol. The exercises will be performed at a slow speed to ensure full control of the movement. Receives: Other: High intensity Traditional Resistance Traning without Blood Flow Restriction |
| High Intensity Traditional Resistance Training with Blood Flow Restriction Group | Experimental | Group B will perform low-load blood flow restriction (LL-BFR) training using external loads of 20-40% 1RM has been suggested as an alternative to traditional strength rehabilitation. Minimum of 2 -3 sets and maximum total 5 sets,20-30 repetitions of each exercise with 30 to 60 seconds rest period and 2-3 times per weekly for 4-6 weeks to During LL-BFR training, a pressurized cuff is applied to the proximal thigh that oc¬cludes venous outflow while maintaining arterial in¬flow. The combination of venous occlusion and resis¬tance training is believed to induce muscle hypertrophy secondary to elevated systematic hormone production, cell swelling, production of reactive oxygen species, intramus¬cular anabolic signaling and fast-twitch fiber recruit¬ment.( Receives: Other: High intensity Traditional Resistance Traning with Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
strength will be measured with hand held dynamometer and 1-RM test
Measured: Pre and 6 weeks post interventions
Agility
Illinois Agility Test Test will be used to measure agility
Measured: Pre and 6 weeks post interventions
Power
Vertical Jump test will be used to measure power
Measured: Pre and 6 weeks post interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start20 Oct 2023
- Primary completion20 Feb 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Resistance TrainingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Nouman Tabassum, DPT, Principal investigator, Ghurki Trust & Teaching Hospital,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131047
- Sponsor's protocol ID
- REC/RCR&AHS/23/0442
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moses B, Orchard J, Orchard J. Systematic review: Annual incidence of ACL injury and surgery in various populations. Res Sports Med. 2012 Jul;20(3-4):157-79. doi: 10.1080/15438627.2012.680633.
PubMed 22742074Kruse LM, Gray B, Wright RW. Rehabilitation after anterior cruciate ligament reconstruction: a systematic review. J Bone Joint Surg Am. 2012 Oct 3;94(19):1737-48. doi: 10.2106/JBJS.K.01246.
PubMed 23032584Elabd OM, Elabd AM. Functional outcomes of a criterion-based rehabilitation protocol for anterior cruciate ligament reconstruction in amateur athletes: A randomised clinical trial. J Bodyw Mov Ther. 2023 Jul;35:7-13. doi: 10.1016/j.jbmt.2023.04.037. Epub 2023 Apr 17.
PubMed 37330806Kirby JC, Whitehead TS, Webster KE, Feller JA, McClelland JA, Klemm HJ, Devitt BM. Impact of Occupation on 12-Month Outcomes After Anterior Cruciate Ligament Reconstruction in Male Patients. Orthop J Sports Med. 2023 Feb 22;11(2):23259671221130377. doi: 10.1177/23259671221130377. eCollection 2023 Feb.
PubMed 36846817Lorenz DS, Bailey L, Wilk KE, Mangine RE, Head P, Grindstaff TL, Morrison S. Blood Flow Restriction Training. J Athl Train. 2021 Sep 1;56(9):937-944. doi: 10.4085/418-20.
PubMed 34530434Koc BB, Truyens A, Heymans MJLF, Jansen EJP, Schotanus MGM. Effect of Low-Load Blood Flow Restriction Training After Anterior Cruciate Ligament Reconstruction: A Systematic Review. Int J Sports Phys Ther. 2022 Apr 1;17(3):334-346. doi: 10.26603/001c.33151. eCollection 2022.
PubMed 35391871
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Resistance Training With and Without Blood Flow Restriction on Quadriceps Strength, Power and Agility in ACL Reconstruction Among Volley Ball Players
- ClinicalTrials.gov ID
- NCT06131047
- Acronym / sponsor ID
- REC/RCR&AHS/23/0442
- Conditions
- Resistance Training, Blood Flow Restriction Therapy, Anterior Cruciate Ligament Reconstruction, Volleyball
- Keywords
- High intensity resistance training, Blood Flow Restriction Traning, ACL reconstruction, Volley ball Players
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 14 Nov 2023 (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.
This study is randomized and single-blinded. Ethical approval is taken from the ethical committee of riphah international university, Lahore. Participants who meet the inclusion criteria will be enrolled in Groups A \& B through the sealed envelop method by the Non-Probability Convenient random sampling technique. Group A will perform traditional High-intensity resistance training without Blood Flow Restriction training after ACL Reconstruction Surgery. Group B will perform traditional High-intensity Resistance training with Blood Flow Restriction training after ACL Reconstruction Surgery.
Detailed description
The objective of the study is to determine the effects of high-intensity resistance training with and without blood flow restriction on quadriceps strength, power, and agility after ACL reconstruction among volleyball players. This study is randomized and single-blinded. Ethical approval is taken from the ethical committee of riphah international university, Lahore. Participants who meet the inclusion criteria will be enrolled in Groups A \& B through the sealed envelop method by the Non-Probability Convenient random sampling technique. Group A will perform traditional High-intensity resistance training without Blood Flow Restriction training after ACL Reconstruction Surgery. Group B will perform traditional High-intensity Resistance training with Blood Flow Restriction training after ACL Reconstruction Surgery. The outcome measures will be assessed by hand held dynamometer.1-RM test, Illinois Agility Test, and Vertical jump test.
The data will be analyzed by SPSS,version 25.Statistical siginificance is P= 0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical trial
| Arm | Type | Receives |
|---|---|---|
| High Intensity Traditional Resistance Training Group | Experimental | Other: High intensity Traditional Resistance Traning without Blood Flow RestrictionGroup A will undergo Traditional Resistance training without blood flow Restriction. A 30-minute progressive, weight training program will be initiated 8 weeks after the ACL-reconstruction and will be conducted subsequent to the individual based program. The resistance (training loads) will be increased when the individual could do more repetitions than the number specified in the weight training protocol. The exercises will be performed at a slow speed to ensure full control of the movement. |
| High Intensity Traditional Resistance Training with Blood Flow Restriction Group | Experimental | Other: High intensity Traditional Resistance Traning with Blood Flow RestrictionGroup B will perform low-load blood flow restriction (LL-BFR) training using external loads of 20-40% 1RM has been suggested as an alternative to traditional strength rehabilitation. Minimum of 2 -3 sets and maximum total 5 sets,20-30 repetitions of each exercise with 30 to 60 seconds rest period and 2-3 times per weekly for 4-6 weeks to During LL-BFR training, a pressurized cuff is applied to the proximal thigh that oc¬cludes venous outflow while maintaining arterial in¬flow. The combination of venous occlusion and resis¬tance training is believed to induce muscle hypertrophy secondary to elevated systematic hormone production, cell swelling, production of reactive oxygen species, intramus¬cular anabolic signaling and fast-twitch fiber recruit¬ment.( |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male players with age group 18 to 25 years,Return to function phase of rehabilitation,Players with Grade III ACL Tear ,Athletes who have been playing for at least 2 years
Key exclusion criteria (1 listed)
- Players after ACL Reconstruction in acute or subacute phase,Players with other biomechanical issues of knee or feet,Players with any hematological disorders or hypertension
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 |
|---|---|---|
| High intensity Traditional Resistance Traning without Blood Flow RestrictionGroup A will undergo Traditional Resistance training without blood flow Restriction. A 30-minute progressive, weight training program will be initiated 8 weeks after the ACL-reconstruction and will be conducted subsequent to the individual based program. The resistance (training loads) will be increased when the individual could do more repetitions than the number specified in the weight training protocol. The exercises will be performed at a slow speed to ensure full control of the movement | Other | High Intensity Traditional Resistance Training Group |
| High intensity Traditional Resistance Traning with Blood Flow RestrictionGroup B will recieve low-load blood flow restriction (LL-BFR) training using external loads of 20-40% 1RM has been suggested as an alternative to traditional strength rehabilitation. Minimum of 2 -3 sets and maximum total 5 sets,20-30 repetitions of each exercise with 30 to 60 seconds rest period and 2-3 times per weekly for 4-6 weeks to During LL-BFR training, a pressurized cuff is applied to the proximal thigh that oc¬cludes venous outflow while maintaining arterial in¬flow. The combination of venous occlusion and resis¬tance training is believed to induce muscle hypertrophy secondary to elevated systematic hormone production, cell swelling, production of reactive oxygen species, intramus¬cular anabolic signaling and fast-twitch fiber recruit¬ment | Other | High Intensity Traditional Resistance Training with Blood Flow Restriction Group |
Primary outcome
Strength
Time frame: Pre and 6 weeks post interventions
strength will be measured with hand held dynamometer and 1-RM test
Agility
Time frame: Pre and 6 weeks post interventions
Illinois Agility Test Test will be used to measure agility
Power
Time frame: Pre and 6 weeks post interventions
Vertical Jump test will be used to measure power
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 22742074Moses B, Orchard J, Orchard J. Systematic review: Annual incidence of ACL injury and surgery in various populations. Res Sports Med. 2012 Jul;20(3-4):157-79. doi: 10.1080/15438627.2012.680633.
- Background: PubMed 23032584Kruse LM, Gray B, Wright RW. Rehabilitation after anterior cruciate ligament reconstruction: a systematic review. J Bone Joint Surg Am. 2012 Oct 3;94(19):1737-48. doi: 10.2106/JBJS.K.01246.
- Background: PubMed 37330806Elabd OM, Elabd AM. Functional outcomes of a criterion-based rehabilitation protocol for anterior cruciate ligament reconstruction in amateur athletes: A randomised clinical trial. J Bodyw Mov Ther. 2023 Jul;35:7-13. doi: 10.1016/j.jbmt.2023.04.037. Epub 2023 Apr 17.
- Background: PubMed 36846817Kirby JC, Whitehead TS, Webster KE, Feller JA, McClelland JA, Klemm HJ, Devitt BM. Impact of Occupation on 12-Month Outcomes After Anterior Cruciate Ligament Reconstruction in Male Patients. Orthop J Sports Med. 2023 Feb 22;11(2):23259671221130377. doi: 10.1177/23259671221130377. eCollection 2023 Feb.
- Background: PubMed 34530434Lorenz DS, Bailey L, Wilk KE, Mangine RE, Head P, Grindstaff TL, Morrison S. Blood Flow Restriction Training. J Athl Train. 2021 Sep 1;56(9):937-944. doi: 10.4085/418-20.
- Background: PubMed 35391871Koc BB, Truyens A, Heymans MJLF, Jansen EJP, Schotanus MGM. Effect of Low-Load Blood Flow Restriction Training After Anterior Cruciate Ligament Reconstruction: A Systematic Review. Int J Sports Phys Ther. 2022 Apr 1;17(3):334-346. doi: 10.26603/001c.33151. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Muhammad Nouman Tabassum, DPT principal investigator
Ghurki Trust & Teaching Hospital,Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity Traditional Resistance Traning without Blood Flow Restriction and High intensity Traditional Resistance Traning with Blood Flow Restriction in people with Resistance Training and Blood Flow Restriction 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Atif Javed, PP-DPT (+92-3317491071, atif.javed@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: Pre and 6 weeks post interventions). The study lists 3 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 NCT06131047, which also lists 6 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 14 Nov 2023.