NCT06846164

Brief Summary

The goal of the study is to find out how mild home exercises (similar to usual care) and progressive strength training, which include neuromuscular exercise, affected knee joint function and HS muscle strength in individuals who has persistent HS muscle strength deficits 12-24 months after ACLR.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

April 24, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

February 20, 2025

Last Update Submit

February 20, 2025

Conditions

Keywords

Anterior Cruciate Ligamentresistance trainingAthletes

Outcome Measures

Primary Outcomes (1)

  • Limb Symmetry Index

    It is used for knee extensors and flexors strength. It is the strength ratio between the injured and uninjured knees. It is a common method of assessing strength and functional performance after ACLR.

    12 weeks

Secondary Outcomes (1)

  • H/Q ratio

    12 weeks

Other Outcomes (1)

  • KOOS questionnaire

    12 weeks

Study Arms (2)

Supervised progressive strength training with elements like (SNG)

EXPERIMENTAL

Participants will be randomized to SNG and perform training sessions (60-70 minutes) twice weekly, over 12 weeks, commencing 8 exercises for the lower extremities in 3 sets of 10 repetitions with an intensity of 12 repetitions maximum. Individual progression, quality of exercise, number of sets, repetitions, and additional training weights will be monitored and adjusted throughout the intervention period by experienced physiotherapists

Other: Supervised progressive strength training including elements of neuromuscular exercise intervention (SNG)

home based low-intensity weight-bearing exercise protocol

EXPERIMENTAL

Participants allocated to CON will receive written and verbal instructions regarding 4 home-based (low-intensity), weight-bearing exercises for the lower extremities, to be performed twice weekly. This intervention is designed to resemble usual care in cases where persistent knee muscle strength deficits would be discovered and considered a clinical issue.

Other: home based low-intensity weight-bearing exercise protocol.

Interventions

Participants will be randomized to SNG and will perform training sessions (60-70 minutes) twice weekly, over a duration of 12 weeks, commencing 8 exercises for the lower extremities in 3 sets of 10 repetitions with an intensity of 12 repetitions maximum. Individual progression, quality of exercise, number of sets, repetitions, and additional training weights will be monitored

Supervised progressive strength training with elements like (SNG)

Participants allocated to CON will receive written and verbal instructions regarding 4 home-based (low intensity), weight-bearing exercises for the lower extremities, to be performed twice weekly. This intervention is designed to resemble usual care in cases where persistent knee muscle strength deficits would be discovered and considered a clinical issue.

home based low-intensity weight-bearing exercise protocol

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 - 30 years
  • months post-surgery (ACL reconstruction)
  • Persistent maximal isometric knee flexor strength asymmetry (\>10% leg-to-leg the difference, in the isometric testing angle of 90° knee flexion)

You may not qualify if:

  • Body mass index \[BMI\] more than 35
  • known lower limb pathology (including previous and/or concomitant knee injuries requiring surgical intervention to either knee)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovative Health Concept

Lahore, 54770, Pakistan

Location

Related Publications (12)

  • Chechik O, Amar E, Khashan M, Lador R, Eyal G, Gold A. An international survey on anterior cruciate ligament reconstruction practices. Int Orthop. 2013 Feb;37(2):201-6. doi: 10.1007/s00264-012-1611-9. Epub 2012 Jul 11.

    PMID: 22782378BACKGROUND
  • Mall NA, Chalmers PN, Moric M, Tanaka MJ, Cole BJ, Bach BR Jr, Paletta GA Jr. Incidence and trends of anterior cruciate ligament reconstruction in the United States. Am J Sports Med. 2014 Oct;42(10):2363-70. doi: 10.1177/0363546514542796. Epub 2014 Aug 1.

    PMID: 25086064BACKGROUND
  • Shaerf DA, Pastides PS, Sarraf KM, Willis-Owen CA. Anterior cruciate ligament reconstruction best practice: A review of graft choice. World J Orthop. 2014 Jan 18;5(1):23-9. doi: 10.5312/wjo.v5.i1.23. eCollection 2014 Jan 18.

    PMID: 24649411BACKGROUND
  • Ardern CL, Webster KE, Taylor NF, Feller JA. Return to the preinjury level of competitive sport after anterior cruciate ligament reconstruction surgery: two-thirds of patients have not returned by 12 months after surgery. Am J Sports Med. 2011 Mar;39(3):538-43. doi: 10.1177/0363546510384798. Epub 2010 Nov 23.

    PMID: 21098818BACKGROUND
  • Filbay SR, Grindem H. Evidence-based recommendations for the management of anterior cruciate ligament (ACL) rupture. Best Pract Res Clin Rheumatol. 2019 Feb;33(1):33-47. doi: 10.1016/j.berh.2019.01.018. Epub 2019 Feb 21.

    PMID: 31431274BACKGROUND
  • Gobbi A, Francisco R. Factors affecting return to sports after anterior cruciate ligament reconstruction with patellar tendon and hamstring graft: a prospective clinical investigation. Knee Surg Sports Traumatol Arthrosc. 2006 Oct;14(10):1021-8. doi: 10.1007/s00167-006-0050-9. Epub 2006 Feb 22.

    PMID: 16496124BACKGROUND
  • Bram JT, Magee LC, Mehta NN, Patel NM, Ganley TJ. Anterior Cruciate Ligament Injury Incidence in Adolescent Athletes: A Systematic Review and Meta-analysis. Am J Sports Med. 2021 Jun;49(7):1962-1972. doi: 10.1177/0363546520959619. Epub 2020 Oct 22.

    PMID: 33090889BACKGROUND
  • Bencke J, Aagaard P, Zebis MK. Muscle Activation During ACL Injury Risk Movements in Young Female Athletes: A Narrative Review. Front Physiol. 2018 May 15;9:445. doi: 10.3389/fphys.2018.00445. eCollection 2018.

    PMID: 29867521BACKGROUND
  • More RC, Karras BT, Neiman R, Fritschy D, Woo SL, Daniel DM. Hamstrings--an anterior cruciate ligament protagonist. An in vitro study. Am J Sports Med. 1993 Mar-Apr;21(2):231-7. doi: 10.1177/036354659302100212.

    PMID: 8465918BACKGROUND
  • Zebis MK, Andersen LL, Bencke J, Kjaer M, Aagaard P. Identification of athletes at future risk of anterior cruciate ligament ruptures by neuromuscular screening. Am J Sports Med. 2009 Oct;37(10):1967-73. doi: 10.1177/0363546509335000. Epub 2009 Jul 2.

    PMID: 19574475BACKGROUND
  • Bieler T, Sobol NA, Andersen LL, Kiel P, Lofholm P, Aagaard P, Magnusson SP, Krogsgaard MR, Beyer N. The effects of high-intensity versus low-intensity resistance training on leg extensor power and recovery of knee function after ACL-reconstruction. Biomed Res Int. 2014;2014:278512. doi: 10.1155/2014/278512. Epub 2014 Apr 27.

    PMID: 24877078BACKGROUND
  • Hanada M, Yoshikura T, Matsuyama Y. Muscle recovery at 1 year after the anterior cruciate ligament reconstruction surgery is associated with preoperative and early postoperative muscular strength of the knee extension. Eur J Orthop Surg Traumatol. 2019 Dec;29(8):1759-1764. doi: 10.1007/s00590-019-02479-3. Epub 2019 Jun 25.

    PMID: 31240385BACKGROUND

Study Officials

  • Hafiz Attiq ur Rehman

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

April 24, 2024

Primary Completion

November 10, 2024

Study Completion

February 25, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations