NCT06131047

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 20, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 9, 2023

Last Update Submit

November 9, 2023

Conditions

Keywords

High intensity resistance trainingBlood Flow Restriction TraningACL reconstructionVolley ball Players

Outcome Measures

Primary Outcomes (3)

  • Strength

    strength will be measured with hand held dynamometer and 1-RM test

    Pre and 6 weeks post interventions

  • Agility

    Illinois Agility Test Test will be used to measure agility

    Pre and 6 weeks post interventions

  • Power

    Vertical Jump test will be used to measure power

    Pre and 6 weeks post interventions

Study Arms (2)

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.

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.(

Other: High intensity Traditional Resistance Traning with Blood Flow Restriction

Interventions

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 Training Group

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

High Intensity Traditional Resistance Training with Blood Flow Restriction Group

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki Trust & Teaching Hospital

Lahore, Punjab Province, 543000, Pakistan

RECRUITING

Related Publications (6)

  • 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.

    PMID: 22742074BACKGROUND
  • 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.

    PMID: 23032584BACKGROUND
  • 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.

    PMID: 37330806BACKGROUND
  • 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.

    PMID: 36846817BACKGROUND
  • 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.

    PMID: 34530434BACKGROUND
  • 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.

    PMID: 35391871BACKGROUND

Study Officials

  • Muhammad Nouman Tabassum, DPT

    Ghurki Trust & Teaching Hospital,Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Atif Javed, PP-DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Asessor who will take readings is blind
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

October 20, 2023

Primary Completion

February 20, 2024

Study Completion

February 20, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations