AzTrials
AzTrials

Sports Physical TherapyNCT06846164

Effects of Progressive Resistance Exercises Among Athletes With Hamstring Deficit After ACL Reconstruction

A study testing Supervised progressive strength training including elements of neuromuscular exercise intervention (SNG) and home based low-intensity weight-bearing exercise protocol. in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Sports Physical Therapy
What is being tested?
Supervised progressive strength training including elements of neuromuscular exercise intervention (SNG) and home based low-intensity weight-bearing exercise protocol.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 sitePakistan
Study dates
24 Apr 2024to 25 Feb 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 - 30 years
  • 12-24 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Innovative Health Concept

    Lahore, 54770

Other trials in Pakistan

About this study

Official title: Effects of Progressive Resistance Exercises on Range of Motion & Strength and Function Among Athletes With Hamstring Deficit After ACL Reconstruction

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.

Read the detailed description

The objective of the present study is to investigate whether individuals, who perform supervised progressive strength training including elements of neuromuscular exercise intervention (SNG) will achieve greater improvements in leg muscle power and greater improvements in knee function compared with individuals performing a homebased low-intensity weight-bearing exercise protocol. We hypothesize that supervised progressive strength training would be superior to a homebased low-intensity weight-bearing exercise protocol for regaining muscle strength and knee function. This study will impact society by promoting health, reducing healthcare costs, supporting productivity, and contributing to a more active and engaged community. Limited investigation exists regarding the durability of progressive resistance exercises in mitigating hamstring deficits post-ACL reconstruction and the personalized optimization of exercise protocols for individual athletes. Further exploration is needed for sustained benefits and tailored rehabilitation strategies.

Being tested
Supervised progressive strength training including elements of neuromuscular exercise intervention (SNG), home based low-intensity weight-bearing exercise protocol.
Keywords
Anterior Cruciate Ligament, resistance training, Athletes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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

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

    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.

Study groups in NCT06846164
Study groupRoleWhat they receive
Supervised progressive strength training with elements like (SNG)ExperimentalParticipants 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
Receives: Other: Supervised progressive strength training including elements of neuromuscular exercise intervention (SNG)
home based low-intensity weight-bearing exercise protocolExperimentalParticipants 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.
Receives: Other: home based low-intensity weight-bearing exercise protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (1)

  1. H/Q ratio

    it is used to detect muscle imbalance, monitor knee joint stability, and indicate lower extremity injury prevention and rehabilitation.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start24 Apr 2024
  3. Primary completion10 Nov 2024
  4. Study completion25 Feb 2025 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06846164
Sponsor's protocol ID
REC/RCR&AHS/24/0409
Status last verified
Feb 2025
First submitted
20 Feb 2025
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22782378

  • 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.

    PubMed 25086064

  • 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.

    PubMed 24649411

  • 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.

    PubMed 21098818

  • 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.

    PubMed 31431274

  • 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.

    PubMed 16496124

  • 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.

    PubMed 33090889

  • 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.

    PubMed 29867521

  • 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.

    PubMed 8465918

  • 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.

    PubMed 19574475

  • 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.

    PubMed 24877078

  • 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.

    PubMed 31240385

Questions about this trial

What is this clinical trial studying?

A study testing Supervised progressive strength training including elements of neuromuscular exercise intervention (SNG) and home based low-intensity weight-bearing exercise protocol. in people with Sports Physical 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Limb Symmetry Index (time frame: 12 weeks). 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 NCT06846164, which also lists 12 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 25 Feb 2025.

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