- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06877741
Comparative Effects of Heavy Slow Resistance Training and Eccentric Overload Training in Runners
Comparative Effects of Heavy Slow Resistance Training and Eccentric Overload Training on Pain, Range of Motion, and Lower Extremity Functions in Runners With Patellar Tendinopathy
Patellar Tendinopathy (PT) also known as Jumper's knee, is characterized by multifaceted activity-related pathology causing anterior knee pain and patellar-tendon dysfunction. It most commonly affects athletic activities that involve jumping and running. Tendinopathy is most likely to be related to mechanical loading and overuse. Athletes suffer from insidious well-localized pain, typically as the athlete starts the activity. Conservative treatment is the first line of treatment in tendinopathy, however, there is no consensus regarding the best treatment. In acute conditions, relative rest rather than immobilization is preferred. The most popular non-operative treatment involves eccentric exercise (EE). It is commonly accepted that surgical treatment must be indicated in motivated patients if carefully followed conservative treatment (physical training, injections, ESWT) is unsuccessful after 3-6 months. In recent studies, isometric and heavy slow resistance (HSR) exercises have demonstrated potential for pain reduction and functional improvement in patellar tendinopathy.
A randomized controlled trial will be conducted at the Pakistan Sports Board (PSB) Coaching Center, Lahore. 18 Subjects will be randomized into two groups; Heavy slow resistance exercises plus eccentric exercises will be given to group A and exercises of 4 sets of 10-20 repetitions will be given. Group B will give Eccentric exercises in 3 sets of 10-20 repetitions. Pre-assessments will be taken through the Numeric Pain Rating Scale (NPRS) for pain, a goniometer for range of motion, Lower extremity function assessment scale to evaluate lower limb functional impairments, and a Visa-P scale for patellar dysfunction. Assessment will be done at baseline and post 4 weeks of training. Data will be analyzed using SPSS software version 21. The normality of data will be checked, and tests will be applied according to the normality of the data, either parametric or non-parametric tests will be used (within a group or between two groups).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of the study is to compare the effects of heavy slow resistance training and eccentric overload training on pain, range of motion, and lower extremity functions in runners with patellar tendinopathy.
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Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan
- Pakistan Sports Board coaching center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- anterior knee pain located on the inferior pole of the patella for at least 3 months while practicing sport;
- age between 18 and 45 years old;
- practicing any kind of sports at least 3 times a week
- score less than 80 on the Victorian Institute of Sport Assessment-Patellar questionnaire (VISA-p).
Exclusion Criteria:
- Knee surgery within the previous 6 months;
- Chronic joint diseases;
- Corticosteroid injection in the patellar tendon within the previous 3 months;
- Anti-inflammatory, analgesic, or antibiotic medications within the previous 48 hours;
- Any other concomitant treatment for PT
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A (Heavy Slow Resistance exercises)
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Pre - assessment will be taken.
Heavy slow resistance exercises will be given to group A and exercises of 4 sets of 10-20 repetitions will be given
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Experimental: Group B (Eccentric exercises).
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Sessions should be conducted 2 times per week, similar to Group A, in 3 sets of 10-20 repetitions.
Exercises focus solely on eccentric loading, such as eccentric squats, eccentric leg presses, and step-down exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire
Time Frame: 4 weeks
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This brief questionnaire assesses (i) symptoms, (ii) simple tests of function and (in') ability to play sport.
Six of the eight questions are scored on a visual analogue scale from 0-10 with 10 representing optimal health.
The maximal VISA score for an asymptomatic, fully performing individual is 100 points and the theoretical minimum is 0 points.
We found the VISA scale to have excellent short-term test retest, and inter-tester reliability both, r>0.95 as well as good short-term stability (r=0.87).(14)
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4 weeks
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NPRS
Time Frame: 4 weeks
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For the NPRS, the intraclass correlation coefficient (ICC) for all subjects is .76
(p < .0001).
The ICC, however, is .90
(p < .0001)(15)
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4 weeks
|
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Goniometer
Time Frame: 4 weeks
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Goniometric measurements are used to quantify baseline limitations of motion, decide on appropriate therapeutic interventions, and document the effectiveness of these interventions
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4 weeks
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LEFS
Time Frame: 4 weeks
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The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks.
The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals.
Internal consistency is α=.96 (N=107).
Test-retest reliability estimates were R=.86 (95% lower limit CI=.80) for the entire sample (n=98) and R=.94 (95% lower limit CI=.89) for the subset of patients with more chronic conditions (n=31)
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aamir Gul Memon, MS, Riphah International University
Publications and helpful links
General Publications
- Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
- Visentini PJ, Khan KM, Cook JL, Kiss ZS, Harcourt PR, Wark JD. The VISA score: an index of severity of symptoms in patients with jumper's knee (patellar tendinosis). Victorian Institute of Sport Tendon Study Group. J Sci Med Sport. 1998 Jan;1(1):22-8. doi: 10.1016/s1440-2440(98)80005-4.
- Muaidi QI. Rehabilitation of patellar tendinopathy. J Musculoskelet Neuronal Interact. 2020 Dec 1;20(4):535-540.
- Lee WC, Ng GY, Zhang ZJ, Malliaras P, Masci L, Fu SN. Changes on Tendon Stiffness and Clinical Outcomes in Athletes Are Associated With Patellar Tendinopathy After Eccentric Exercise. Clin J Sport Med. 2020 Jan;30(1):25-32. doi: 10.1097/JSM.0000000000000562.
- Schwartz A, Watson JN, Hutchinson MR. Patellar Tendinopathy. Sports Health. 2015 Sep-Oct;7(5):415-20. doi: 10.1177/1941738114568775. Epub 2015 Jan 23.
- Rudavsky A, Cook J. Physiotherapy management of patellar tendinopathy (jumper's knee). J Physiother. 2014 Sep;60(3):122-9. doi: 10.1016/j.jphys.2014.06.022. Epub 2014 Aug 3. No abstract available.
- Visnes H, Bahr R. The evolution of eccentric training as treatment for patellar tendinopathy (jumper's knee): a critical review of exercise programmes. Br J Sports Med. 2007 Apr;41(4):217-23. doi: 10.1136/bjsm.2006.032417. Epub 2007 Jan 29.
- Rodriguez-Merchan EC. The treatment of patellar tendinopathy. J Orthop Traumatol. 2013 Jun;14(2):77-81. doi: 10.1007/s10195-012-0220-0. Epub 2012 Dec 28.
- van Rijn D, van den Akker-Scheek I, Steunebrink M, Diercks RL, Zwerver J, van der Worp H. Comparison of the Effect of 5 Different Treatment Options for Managing Patellar Tendinopathy: A Secondary Analysis. Clin J Sport Med. 2019 May;29(3):181-187. doi: 10.1097/JSM.0000000000000520.
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- Chung H, Lee S, Kim GA, Kim WH. Down-expression of klotho in canine mammary gland tumors and its prognostic significance. PLoS One. 2022 Jun 6;17(6):e0265248. doi: 10.1371/journal.pone.0265248. eCollection 2022.
- Caradu C, Dubourg AP, Colacchio EC, Midy D, Berard X, Ducasse E. Endovascular Treatment of Complex Aneurysms with the Use of Covera Stent Grafts. J Vasc Interv Radiol. 2019 Dec;30(12):1942-1948.e1. doi: 10.1016/j.jvir.2019.05.004. Epub 2019 Sep 14.
- Shen J, Li X, Yan X. Mechanical and Acoustic Properties of Jute Fiber-Reinforced Polypropylene Composites. ACS Omega. 2021 Nov 13;6(46):31154-31160. doi: 10.1021/acsomega.1c04605. eCollection 2021 Nov 23.
- Martindale S, Mableson H, Bodimeade C, Hume H, Badia X, Karim J, Mahmood ASMS, Chiphwanya J, Rimal P, Boko-Collins P, Bougma R, Agyemang D, Alomatu B, Cisse A, Bathiri SA, Shu'aibu J, Betts H, Kelly-Hope LA, Riches N. The development and roll-out of a new hydrocoele surgery facility assessment tool for the elimination of lymphatic filariasis. Int Health. 2022 Sep 21;14(Suppl 2):ii55-ii63. doi: 10.1093/inthealth/ihac020. Erratum In: Int Health. 2023 Mar 1;15(2):233. doi: 10.1093/inthealth/ihac086.
- Pearce L. Recovery through suggestion. Nurs Stand. 2013 Jul 3-9;27(44):20. doi: 10.7748/ns2013.07.27.44.20.s28.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0417
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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