Dynamic Knee ValgusNCT05695482
Progressive Resistance Training Compared to Neuromuscular Exercises on Knee Kinematics
A study testing Neuromuscular training exercises and Hip abductors muscular strength exercises in people with Dynamic Knee Valgus and Injury Prevention, run by University of Thessaly at 1 site in Greece.
Trial summary
The primary aim of this randomized controlled trial is to investigate the effectiveness of 6 weeks of progressive resistance training (PRT) compared to neuromuscular training (NMT) on functional performance in healthy female participants as measured by the Single-Leg Landing (SLL) and Single-Leg Squat (SLS) tests. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dynamic Knee Valgus, Injury Prevention
- What is being tested?
- Neuromuscular training exercises and Hip abductors muscular strength exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteGreece
- Study dates
- 7 Feb 2023to 26 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female gender
- older than 18 and younger than 35 years of age
- physically able to perform physical activities and exercise
- participants should know the greek language in order to understand the instructions and be able to read the consent form
Who cannot join
- undergoing treatment for lower extremity injury
- currently experiencing an average overall pain severity ≥3 out of 10 on an 11-point numerical rating scale in the past week
- history of knee pain in the proceeding twelve months, history of lower limb surgery, known rheumatologic, neurological or cardiovascular disorders with raised blood pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progressive Resistance Training Compared to Neuromuscular Exercises on Knee Kinematics in Two Functional Tests. Α Single-blinded Randomised Controlled Trial Protocol.
The primary aim of this randomized controlled trial is to investigate the effectiveness of 6 weeks of progressive resistance training (PRT) compared to neuromuscular training (NMT) on functional performance in healthy female participants as measured by the Single-Leg Landing (SLL) and Single-Leg Squat (SLS) tests.
The secondary aims are to investigate the,
- change in abduction hip muscle strength, which will be measured with a Biodex System 3 Isokinetic Dynamometer. Outcomes will be measured at baseline and after 6 weeks of intervention.
- adherence to the 6-week initial intervention (High adherence is defined as ≥ 80% attendance to the supervised interventions.)
Read the detailed description
Participants will be randomized into two groups: PRT or NMT. Outcomes will be measured at baseline and after 6 weeks of intervention.
All sessions will be conducted in group sessions, with one researcher supervising the exercises. Patients receive education as well as supervised exercise from trained physiotherapists. Each session will last approximately 25-30 minutes. The duration of the program will be 6 weeks, with 3 sessions every week (total: 18 training sessions).
The NMT intervention sessions consist of a 5-minute submaximal warm-up followed by 25 minutes of NMT training with exercises focused on functional stability, proprioception, strength, stability, agility, postural function, and postural orientation. The training sessions will consist of two parts: warming up and the circuit program. The circuit program will consist of 8 exercises. Each exercise will be performed for 2 sets of 10 repetitions, with a rest of 30 sec corresponding to every set, between each set and exercises. The exercises will be focused on one knee, which will then be evaluated. Three levels of difficulty will be given for each exercise to allow for progression. Every 2 weeks, there will be a progression that will be achieved by changing the exercise and gradually making it harder, or/and changing the support surface.
In the PRT intervention, the sessions will consist of a 5-minute submaximal warm-up followed by 20 minutes of PRT with exercises targeting the abductor muscles of the hip joint. The circuit program will consist of three exercises. Each exercise will be performed in sets of three, then increased to four sets of ten repetitions, with a 30-second rest between each set and exercise.
The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete three sets of 8-12 repetitions for a given exercise and a Borg Rating of Perceived Exertion (RPE) of 6-10. The progression will be in line with guidelines provided by the American College of Sports Medicine.
Adherence to the program for both groups will be assessed by the total number of training sessions performed in 6 weeks (total = 18 training sessions).
- Conditions
- Dynamic Knee Valgus, Injury Prevention
- Being tested
- Neuromuscular training exercises, Hip abductors muscular strength exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular training exercisesOther
The 6-week exercise intervention consists of 25-minute group sessions of Neuromuscular training supervised by a researcher.
Hip abductors muscular strength exercisesOther
The 6-week exercise intervention consists of of 20-minute group sessions of progressive resistance training, supervised by a researcher.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular exercise training (NMT) | Experimental | The 6-week exercise intervention consists of group sessions of Neuromuscular training supervised by a researcher 3 times per week. Participants will be familiarized with the exercises on a separate day prior to testing.
Each session consists of a 5-minute submaximal warm-up followed by 25 minutes of NM training with closed kinetic chain exercises.
Every 2 weeks, there will be a progression that will be achieved by increasing the level of difficulty of each the exercise. We will take into consideration when an exercise is performed with appropriate sensorimotor control, quality of the performance, minimal exertion and control of the movement. Participants will be given special equipment including a step measuring 20 cm in height, an uneven surface, a slider and an elastic tubing medium load (green) from Thera BandTM, (Akron, Ohio, USA). Receives: Other: Neuromuscular training exercises |
| Progressive Resistance Training (PRT) | Experimental | The 6-week exercise intervention consists of group sessions of progressive resistance training supervised by a researcher 3 times per week. Participants will be familiarized with the exercises on a separate day prior to testing.
Each session consists of a 5-minute submaximal warm-up followed by 20 minutes of PRT with an open kinetic chain (no weight-bearing exercises) targeting the abductors' muscles of the hip joint. The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete three sets of 8-12 repetitions for a given exercise and a Borg Rating of Perceived Exertion (RPE) of 6-8.
Every 2 weeks, there will be a progression achieved by changing the resistance in line with guidelines provided by the American College of Sports Medicine with an elastic tubing heavy load (grey) from Thera BandTM, (Akron, Ohio, USA) Receives: Other: Hip abductors muscular strength exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in knee kinematics measured during a Single-Leg Squat functional test
Dynamic Knee Valgus (recorded in degrees) will be assessed during a Single-Leg Squat test. Changes during the test will be analyzed with the Kinovea program.
Measured: Measured at baseline and Week 6.
Changes in knee kinematics measured during a Single-Leg Landing functional test
Dynamic Knee Valgus (recorded in degrees) will be assessed during a Single-Leg Landing test. Changes during the test will be analyzed with the Kinovea program.
Measured: Measured at baseline and Week 6.
Secondary outcomes (2)
Change in abduction hip muscle power
Change in abduction hip muscle power (measured in Newtons) will be measured with a Biodex System 3 isokinetic dynamometer.
Measured: Measured at baseline and Week 6.
Adherence to the 6-week initial intervention
High adherence is defined as ≥ 80% attendance to the supervised interventions.
Measured: Measured at Week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start7 Feb 2023
- Primary completion21 Mar 2023
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dynamic Knee ValgusStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savvas Spanos, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695482
- Sponsor's protocol ID
- Interventional
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kraemer WJ, Adams K, Cafarelli E, Dudley GA, Dooly C, Feigenbaum MS, Fleck SJ, Franklin B, Fry AC, Hoffman JR, Newton RU, Potteiger J, Stone MH, Ratamess NA, Triplett-McBride T; American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2002 Feb;34(2):364-80. doi: 10.1097/00005768-200202000-00027.
PubMed 11828249Ageberg E, Roos EM. Neuromuscular exercise as treatment of degenerative knee disease. Exerc Sport Sci Rev. 2015 Jan;43(1):14-22. doi: 10.1249/JES.0000000000000030.
PubMed 25390299Day ML, McGuigan MR, Brice G, Foster C. Monitoring exercise intensity during resistance training using the session RPE scale. J Strength Cond Res. 2004 May;18(2):353-8. doi: 10.1519/R-13113.1.
PubMed 15142026Peixoto Leao Almeida G, Oliveira Monteiro I, Larissa Azevedo Tavares M, Lourinho Sales Porto P, Rocha Albano T, Pasqual Marques A. Hip abductor versus adductor strengthening for clinical outcomes in knee symptomatic osteoarthritis: A randomized controlled trial. Musculoskelet Sci Pract. 2022 Oct;61:102575. doi: 10.1016/j.msksp.2022.102575. Epub 2022 May 13.
PubMed 35780637Horsak B, Artner D, Baca A, Pobatschnig B, Greber-Platzer S, Nehrer S, Wondrasch B. The effects of a strength and neuromuscular exercise programme for the lower extremity on knee load, pain and function in obese children and adolescents: study protocol for a randomised controlled trial. Trials. 2015 Dec 23;16:586. doi: 10.1186/s13063-015-1091-5.
PubMed 26700568Bennell KL, Kyriakides M, Metcalf B, Egerton T, Wrigley TV, Hodges PW, Hunt MA, Roos EM, Forbes A, Ageberg E, Hinman RS. Neuromuscular versus quadriceps strengthening exercise in patients with medial knee osteoarthritis and varus malalignment: a randomized controlled trial. Arthritis Rheumatol. 2014 Apr;66(4):950-9. doi: 10.1002/art.38317.
PubMed 24757146Clausen B, Holsgaard-Larsen A, Roos EM. An 8-Week Neuromuscular Exercise Program for Patients With Mild to Moderate Knee Osteoarthritis: A Case Series Drawn From a Registered Clinical Trial. J Athl Train. 2017 Jun 2;52(6):592-605. doi: 10.4085/1062-6050-52.5.06.
PubMed 28653869Stefanouli V, Kapreli E, Anastasiadi E, Nakastsis A, Strimpakos N. Validity and reliability of the Greek version of modified Baecke questionnaire. Public Health. 2022 Feb;203:58-64. doi: 10.1016/j.puhe.2021.11.017. Epub 2022 Jan 13.
PubMed 35032916Palmer K, Hebron C, Williams JM. A randomised trial into the effect of an isolated hip abductor strengthening programme and a functional motor control programme on knee kinematics and hip muscle strength. BMC Musculoskelet Disord. 2015 May 3;16:105. doi: 10.1186/s12891-015-0563-9.
PubMed 25935843
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Resistance Training Compared to Neuromuscular Exercises on Knee Kinematics in Two Functional Tests. Α Single-blinded Randomised Controlled Trial Protocol.
- ClinicalTrials.gov ID
- NCT05695482
- Acronym / sponsor ID
- Interventional
- Conditions
- Dynamic Knee Valgus, Injury Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this randomized controlled trial is to investigate the effectiveness of 6 weeks of progressive resistance training (PRT) compared to neuromuscular training (NMT) on functional performance in healthy female participants as measured by the Single-Leg Landing (SLL) and Single-Leg Squat (SLS) tests.
The secondary aims are to investigate the,
- change in abduction hip muscle strength, which will be measured with a Biodex System 3 Isokinetic Dynamometer. Outcomes will be measured at baseline and after 6 weeks of intervention.
- adherence to the 6-week initial intervention (High adherence is defined as ≥ 80% attendance to the supervised interventions.)
Detailed description
Participants will be randomized into two groups: PRT or NMT. Outcomes will be measured at baseline and after 6 weeks of intervention.
All sessions will be conducted in group sessions, with one researcher supervising the exercises. Patients receive education as well as supervised exercise from trained physiotherapists. Each session will last approximately 25-30 minutes. The duration of the program will be 6 weeks, with 3 sessions every week (total: 18 training sessions).
The NMT intervention sessions consist of a 5-minute submaximal warm-up followed by 25 minutes of NMT training with exercises focused on functional stability, proprioception, strength, stability, agility, postural function, and postural orientation. The training sessions will consist of two parts: warming up and the circuit program. The circuit program will consist of 8 exercises. Each exercise will be performed for 2 sets of 10 repetitions, with a rest of 30 sec corresponding to every set, between each set and exercises. The exercises will be focused on one knee, which will then be evaluated. Three levels of difficulty will be given for each exercise to allow for progression. Every 2 weeks, there will be a progression that will be achieved by changing the exercise and gradually making it harder, or/and changing the support surface.
In the PRT intervention, the sessions will consist of a 5-minute submaximal warm-up followed by 20 minutes of PRT with exercises targeting the abductor muscles of the hip joint. The circuit program will consist of three exercises. Each exercise will be performed in sets of three, then increased to four sets of ten repetitions, with a 30-second rest between each set and exercise.
The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete three sets of 8-12 repetitions for a given exercise and a Borg Rating of Perceived Exertion (RPE) of 6-10. The progression will be in line with guidelines provided by the American College of Sports Medicine.
Adherence to the program for both groups will be assessed by the total number of training sessions performed in 6 weeks (total = 18 training sessions).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular exercise training (NMT) | Experimental | Other: Neuromuscular training exercisesThe 6-week exercise intervention consists of group sessions of Neuromuscular training supervised by a researcher 3 times per week. Participants will be familiarized with the exercises on a separate day prior to testing. Each session consists of a 5-minute submaximal warm-up followed by 25 minutes of NM training with closed kinetic chain exercises. Every 2 weeks, there will be a progression that will be achieved by increasing the level of difficulty of each the exercise. We will take into consideration when an exercise is performed with appropriate sensorimotor control, quality of the performance, minimal exertion and control of the movement. Participants will be given special equipment including a step measuring 20 cm in height, an uneven surface, a slider and an elastic tubing medium load (green) from Thera BandTM, (Akron, Ohio, USA). |
| Progressive Resistance Training (PRT) | Experimental | Other: Hip abductors muscular strength exercisesThe 6-week exercise intervention consists of group sessions of progressive resistance training supervised by a researcher 3 times per week. Participants will be familiarized with the exercises on a separate day prior to testing. Each session consists of a 5-minute submaximal warm-up followed by 20 minutes of PRT with an open kinetic chain (no weight-bearing exercises) targeting the abductors' muscles of the hip joint. The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete three sets of 8-12 repetitions for a given exercise and a Borg Rating of Perceived Exertion (RPE) of 6-8. Every 2 weeks, there will be a progression achieved by changing the resistance in line with guidelines provided by the American College of Sports Medicine with an elastic tubing heavy load (grey) from Thera BandTM, (Akron, Ohio, USA) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female gender
- older than 18 and younger than 35 years of age
- physically able to perform physical activities and exercise
- participants should know the greek language in order to understand the instructions and be able to read the consent form
Key exclusion criteria (3 listed)
- undergoing treatment for lower extremity injury
- currently experiencing an average overall pain severity ≥3 out of 10 on an 11-point numerical rating scale in the past week
- history of knee pain in the proceeding twelve months, history of lower limb surgery, known rheumatologic, neurological or cardiovascular disorders with raised blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular training exercisesThe 6-week exercise intervention consists of 25-minute group sessions of Neuromuscular training supervised by a researcher. | Other | Neuromuscular exercise training (NMT) |
| Hip abductors muscular strength exercisesThe 6-week exercise intervention consists of of 20-minute group sessions of progressive resistance training, supervised by a researcher. | Other | Progressive Resistance Training (PRT) |
Primary outcome
Changes in knee kinematics measured during a Single-Leg Squat functional test
Time frame: Measured at baseline and Week 6.
Dynamic Knee Valgus (recorded in degrees) will be assessed during a Single-Leg Squat test. Changes during the test will be analyzed with the Kinovea program.
Changes in knee kinematics measured during a Single-Leg Landing functional test
Time frame: Measured at baseline and Week 6.
Dynamic Knee Valgus (recorded in degrees) will be assessed during a Single-Leg Landing test. Changes during the test will be analyzed with the Kinovea program.
2 secondary outcomes
Change in abduction hip muscle power
Time frame: Measured at baseline and Week 6.
Adherence to the 6-week initial intervention
Time frame: Measured at Week 6.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 11828249Kraemer WJ, Adams K, Cafarelli E, Dudley GA, Dooly C, Feigenbaum MS, Fleck SJ, Franklin B, Fry AC, Hoffman JR, Newton RU, Potteiger J, Stone MH, Ratamess NA, Triplett-McBride T; American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2002 Feb;34(2):364-80. doi: 10.1097/00005768-200202000-00027.
- Background: PubMed 25390299Ageberg E, Roos EM. Neuromuscular exercise as treatment of degenerative knee disease. Exerc Sport Sci Rev. 2015 Jan;43(1):14-22. doi: 10.1249/JES.0000000000000030.
- Background: PubMed 15142026Day ML, McGuigan MR, Brice G, Foster C. Monitoring exercise intensity during resistance training using the session RPE scale. J Strength Cond Res. 2004 May;18(2):353-8. doi: 10.1519/R-13113.1.
- Background: PubMed 35780637Peixoto Leao Almeida G, Oliveira Monteiro I, Larissa Azevedo Tavares M, Lourinho Sales Porto P, Rocha Albano T, Pasqual Marques A. Hip abductor versus adductor strengthening for clinical outcomes in knee symptomatic osteoarthritis: A randomized controlled trial. Musculoskelet Sci Pract. 2022 Oct;61:102575. doi: 10.1016/j.msksp.2022.102575. Epub 2022 May 13.
- Background: PubMed 26700568Horsak B, Artner D, Baca A, Pobatschnig B, Greber-Platzer S, Nehrer S, Wondrasch B. The effects of a strength and neuromuscular exercise programme for the lower extremity on knee load, pain and function in obese children and adolescents: study protocol for a randomised controlled trial. Trials. 2015 Dec 23;16:586. doi: 10.1186/s13063-015-1091-5.
- Background: PubMed 24757146Bennell KL, Kyriakides M, Metcalf B, Egerton T, Wrigley TV, Hodges PW, Hunt MA, Roos EM, Forbes A, Ageberg E, Hinman RS. Neuromuscular versus quadriceps strengthening exercise in patients with medial knee osteoarthritis and varus malalignment: a randomized controlled trial. Arthritis Rheumatol. 2014 Apr;66(4):950-9. doi: 10.1002/art.38317.
- Background: PubMed 28653869Clausen B, Holsgaard-Larsen A, Roos EM. An 8-Week Neuromuscular Exercise Program for Patients With Mild to Moderate Knee Osteoarthritis: A Case Series Drawn From a Registered Clinical Trial. J Athl Train. 2017 Jun 2;52(6):592-605. doi: 10.4085/1062-6050-52.5.06.
- Background: PubMed 35032916Stefanouli V, Kapreli E, Anastasiadi E, Nakastsis A, Strimpakos N. Validity and reliability of the Greek version of modified Baecke questionnaire. Public Health. 2022 Feb;203:58-64. doi: 10.1016/j.puhe.2021.11.017. Epub 2022 Jan 13.
- Background: PubMed 25935843Palmer K, Hebron C, Williams JM. A randomised trial into the effect of an isolated hip abductor strengthening programme and a functional motor control programme on knee kinematics and hip muscle strength. BMC Musculoskelet Disord. 2015 May 3;16:105. doi: 10.1186/s12891-015-0563-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular training exercises and Hip abductors muscular strength exercises in people with Dynamic Knee Valgus and Injury Prevention, run by University of Thessaly at 1 site in Greece.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Mar 2023. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in knee kinematics measured during a Single-Leg Squat functional test (time frame: Measured at baseline and Week 6.). The study lists 2 primary outcomes in all. 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 NCT05695482, which also lists 9 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 29 Mar 2023.