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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06131047
Other study ID # REC/RCR&AHS/23/0442
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2023
Est. completion date February 20, 2024

Study information

Verified date November 2023
Source Riphah International University
Contact Muhammad Atif Javed, PP-DPT
Phone +92-3317491071
Email atif.javed@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 26
Est. completion date February 20, 2024
Est. primary completion date February 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
High intensity Traditional Resistance Traning without Blood Flow Restriction
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 Restriction
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

Locations

Country Name City State
Pakistan Ghurki Trust & Teaching Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Strength strength will be measured with hand held dynamometer and 1-RM test Pre and 6 weeks post interventions
Primary Agility Illinois Agility Test Test will be used to measure agility Pre and 6 weeks post interventions
Primary Power Vertical Jump test will be used to measure power Pre and 6 weeks post interventions
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