- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06846164
Effects of Progressive Resistance Exercises Among Athletes With Hamstring Deficit After ACL Reconstruction
February 20, 2025 updated by: Riphah International University
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.
Study Overview
Status
Active, not recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Lahore, Pakistan, 54770
- Innovative Health Concept
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Body mass index [BMI] more than 35
- known lower limb pathology (including previous and/or concomitant knee injuries requiring surgical intervention to either knee)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supervised progressive strength training with elements like (SNG)
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
|
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
|
|
Experimental: home based low-intensity weight-bearing exercise protocol
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Limb Symmetry Index
Time Frame: 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
H/Q ratio
Time Frame: 12 weeks
|
it is used to detect muscle imbalance, monitor knee joint stability, and indicate lower extremity injury prevention and rehabilitation.
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
KOOS questionnaire
Time Frame: 12 weeks
|
It is used to assess five outcomes: pain, activity of daily living, sport and recreation function, and knee-related quality of life.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hafiz Attiq ur Rehman, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2024
Primary Completion (Actual)
November 10, 2024
Study Completion (Estimated)
February 25, 2025
Study Registration Dates
First Submitted
February 20, 2025
First Submitted That Met QC Criteria
February 20, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 20, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- REC/RCR&AHS/24/0409
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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