- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06131047
High Intensity Resistance Training With and Without Blood Flow Restriction in ACL Reconstruction
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
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Atif Javed, PP-DPT
- Phone Number: +92-3317491071
- Email: atif.javed@riphah.edu.pk
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 543000
- Recruiting
- Ghurki Trust & Teaching Hospital
-
Sub-Investigator:
- Muhammad Atif Javed, PP-DPT
-
Contact:
- Hafiz Muhammad Asim, PhD
- Phone Number: +923009400346
- Email: Dean.lcp@lmdc.edu.pk
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Contact:
- Muhammad Nouman tabassum, DPT
- Phone Number: +923336849593
- Email: nouman06@gmail.com
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Principal Investigator:
- Muhammad Nouman Tabassum, DPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Intensity Traditional Resistance Training Group
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.
|
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
|
|
Experimental: High Intensity Traditional Resistance Training with Blood Flow Restriction Group
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.(
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength
Time Frame: Pre and 6 weeks post interventions
|
strength will be measured with hand held dynamometer and 1-RM test
|
Pre and 6 weeks post interventions
|
|
Agility
Time Frame: Pre and 6 weeks post interventions
|
Illinois Agility Test Test will be used to measure agility
|
Pre and 6 weeks post interventions
|
|
Power
Time Frame: Pre and 6 weeks post interventions
|
Vertical Jump test will be used to measure power
|
Pre and 6 weeks post interventions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Nouman Tabassum, DPT, Ghurki Trust & Teaching Hospital,Lahore
Publications and helpful links
General 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.
- Kruse 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.
- Elabd 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.
- Kirby 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.
- Lorenz 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.
- Koc 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/RCR&AHS/23/0442
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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