Patellar TendinitisNCT03917849
Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy
A study testing Exercises program for patellar tendinopathy in people with Patellar Tendinitis and Jumper's Knee, run by Universidad Nacional de Córdoba at 2 sites in Argentina.
Trial summary
The purpose of this project is to investigate the efficacy of Inertial Flywheel Resistance program vs Heavy slow resistance in patients with chronic patellar tendinopathy. The investigators hypothesize that Inertial Flywheel Resistance program will yield a more positive clinical outcome and function in patients with… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patellar Tendinitis, Jumper's Knee
- What is being tested?
- Exercises program for patellar tendinopathy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesArgentina
- Study dates
- 2 Jan 2018to 22 Mar 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of patellar tendinopathy
- Symptoms > 3 months
- Pain localized to the inferior pole of the patella
- Victorian Institute of Sport Assessment (VISA) score less than 80 points
- Palpation tenderness of the patellar tendon
- Abnormal tendon (hypoechoic) confirmed by ultrasonography.
Who cannot join
- Previous knee surgery
- Confounding diagnosis to the knee joint
- Previous corticosteroids injections
- Arthritis or diabetes
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites
Universidad Nacional de Cordoba
Córdoba, C, 5000
Universidad Nacional de Cordoba
Córdoba, 5000
About this study
The purpose of this project is to investigate the efficacy of Inertial Flywheel Resistance program vs Heavy slow resistance in patients with chronic patellar tendinopathy.
The investigators hypothesize that Inertial Flywheel Resistance program will yield a more positive clinical outcome and function in patients with patellar tendinopathy compared to heavy slow resistance group.
Read the detailed description
Randomized controlled intervention study
- Conditions
- Patellar Tendinitis, Jumper's Knee
- Being tested
- Exercises program for patellar tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises program for patellar tendinopathyBehavioural
To compare the effectiveness of the inertial flywheel resistance program versus slow heavy resistance in patients with chronic patellar tendinopathy
| Study group | Role | What they receive |
|---|---|---|
| Heavy slow resistance training | Experimental | The program is performed 3 times per week using resistance equipment in a fitness center. Each session consists of three 2-legged loaded quadriceps and lower limb kinetic chain exercises. The patients complete 3 or 4 sets in each exercise with a 2- to 3-minute rest between sets and a 5-minute rest period between the 3 exercises.
The number of repetitions decreases, and load gradually increases, every week. The repetitions and loads are as follows: 3 times, 15-repetition maximum (15RM ), in week 1; 3 times, 12RM , in weeks 2 to 3; 4 times, 10RM , in weeks 4 to 5; 4 times, 8RM , in weeks 6 to 8; and 4 times, 6RM , in weeks 9 to 12. Receives: Behavioral: Exercises program for patellar tendinopathy |
| Inertial flywheel resistance training | Experimental | The program is performed 3 times per week using resistance equipment in a fitness center. Inertial flywheel resistance is a type of strength training; which is based on the increasing demands on eccentric action (breaking) after a concentric action (acceleration), due to the inertial load caused during the return movement. The patients complete 12 repetition máximum (RM) with moment inertia 0.05 m² from week 1-6 and 8 repetition máximum (RM) with moment inertia = 0.10 m² from week 6-12. Receives: Behavioral: Exercises program for patellar tendinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Victorian Institute of Sports Assessment (VISA-P questionnaire)
Self-administered questionnaire. Consists of 8 items; 6 are used to evaluate pain levels or disability in daily activities and specific functional tests and 2 provide information regarding ability to play sport. Response options for each item are provided on a numeric rating scale (from 0 to 10), with higher scores indicating lower levels of pain or disability for all items other than 7 and 8, for which options have weighted scores.
Measured: 0 - 12 weeks
Secondary outcomes (7)
Patient-Specific Functional Scale
Self-reported patient-specific outcome measure assess functional change, primarily in patients presenting with musculoskeletal disorders. Patients are asked to identify up to 3 important activities they are unable to perform or are having difficulty with as a result of their problem. In addition to identifying the activities, patients are asked to rate, on an 11-point scale, the current level of difficulty associated with each activity. Following the intervention, patients are asked again to rate the activities previously identified.
Measured: 0 - 12 weeks
Patient Global Impression of Change
Register patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Measured: 12 weeks
Adverse events
To capture all adverse events and side effects that occurred after exercises protocol. Patients reported any changes or any symptoms. If a question was answered "yes", we asked for further comments.
Measured: 12 weeks
Adherence self-report questionnaire
Patients were asked to choose one of six descriptions (from level 1 = perfect adherence to level 6 = nonadherence) to express exercise treatment at the end of the twelve weeks study period.
Measured: 12 weeks
Single-leg decline squat (SLDS) test
A reliable patellar tendon pain provocation test, will be used to assess pain. Pain is rated on an 11-point numeric rating scale, where 0 is no pain and 10 is the worst pain imaginable.
Measured: 0 - 12 weeks
Knee extension machine test
A reliable patellar tendon pain provocation test, will be used to assess pain. Pain is rated on an 11-point numeric rating scale, where 0 is no pain and 10 is the worst pain imaginable.
Measured: 0 - 12 weeks
Jump test
Counter movement Jump and Triple hop for distance will be used to assess patellar tendinopathy caused functional deficits on the injured site compared with the non-injured site. The distance is measured in centimeters.
Measured: 0 - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start2 Jan 2018
- Primary completion22 Mar 2020
- Study completion22 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellar TendinitisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Andres Ruffino, Universidad Nacional de Córdoba
- Investigators
- Vilma Campana, Dr, Study director, Departments of Biomedical Physics - University of Cordoba Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917849
- Sponsor's protocol ID
- UCordoba
- Status last verified
- Jul 2020
- First submitted
- 8 Apr 2019
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruffino D, Malliaras P, Marchegiani S, Campana V. Inertial flywheel vs heavy slow resistance training among athletes with patellar tendinopathy: A randomised trial. Phys Ther Sport. 2021 Nov;52:30-37. doi: 10.1016/j.ptsp.2021.08.002. Epub 2021 Aug 4.
PubMed 34384941
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT03917849
- Acronym / sponsor ID
- UCordoba
- Conditions
- Patellar Tendinitis, Jumper's Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad Nacional de CórdobaUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 22 Mar 2020 (actual)
- Study completion
- 22 Mar 2020 (actual)
- First posted
- 17 Apr 2019 (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 purpose of this project is to investigate the efficacy of Inertial Flywheel Resistance program vs Heavy slow resistance in patients with chronic patellar tendinopathy.
The investigators hypothesize that Inertial Flywheel Resistance program will yield a more positive clinical outcome and function in patients with patellar tendinopathy compared to heavy slow resistance group.
Detailed description
Randomized controlled intervention study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy slow resistance training | Experimental | Behavioral: Exercises program for patellar tendinopathyThe program is performed 3 times per week using resistance equipment in a fitness center. Each session consists of three 2-legged loaded quadriceps and lower limb kinetic chain exercises. The patients complete 3 or 4 sets in each exercise with a 2- to 3-minute rest between sets and a 5-minute rest period between the 3 exercises. The number of repetitions decreases, and load gradually increases, every week. The repetitions and loads are as follows: 3 times, 15-repetition maximum (15RM ), in week 1; 3 times, 12RM , in weeks 2 to 3; 4 times, 10RM , in weeks 4 to 5; 4 times, 8RM , in weeks 6 to 8; and 4 times, 6RM , in weeks 9 to 12. |
| Inertial flywheel resistance training | Experimental | Behavioral: Exercises program for patellar tendinopathyThe program is performed 3 times per week using resistance equipment in a fitness center. Inertial flywheel resistance is a type of strength training; which is based on the increasing demands on eccentric action (breaking) after a concentric action (acceleration), due to the inertial load caused during the return movement. The patients complete 12 repetition máximum (RM) with moment inertia 0.05 m² from week 1-6 and 8 repetition máximum (RM) with moment inertia = 0.10 m² from week 6-12. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of patellar tendinopathy
- Symptoms > 3 months
- Pain localized to the inferior pole of the patella
- Victorian Institute of Sport Assessment (VISA) score less than 80 points
- Palpation tenderness of the patellar tendon
Key exclusion criteria (4 listed)
- Previous knee surgery
- Confounding diagnosis to the knee joint
- Previous corticosteroids injections
- Arthritis or diabetes
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 |
|---|---|---|
| Exercises program for patellar tendinopathyTo compare the effectiveness of the inertial flywheel resistance program versus slow heavy resistance in patients with chronic patellar tendinopathy | Behavioural | Heavy slow resistance training, Inertial flywheel resistance training |
Primary outcome
Victorian Institute of Sports Assessment (VISA-P questionnaire)
Time frame: 0 - 12 weeks
Self-administered questionnaire. Consists of 8 items; 6 are used to evaluate pain levels or disability in daily activities and specific functional tests and 2 provide information regarding ability to play sport. Response options for each item are provided on a numeric rating scale (from 0 to 10), with higher scores indicating lower levels of pain or disability for all items other than 7 and 8, for which options have weighted scores.
7 secondary outcomes
Patient-Specific Functional Scale
Time frame: 0 - 12 weeks
Patient Global Impression of Change
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Adherence self-report questionnaire
Time frame: 12 weeks
Single-leg decline squat (SLDS) test
Time frame: 0 - 12 weeks
Knee extension machine test
Time frame: 0 - 12 weeks
Jump test
Time frame: 0 - 12 weeks
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 15 Jul 2020.
- Derived from this study: PubMed 34384941Ruffino D, Malliaras P, Marchegiani S, Campana V. Inertial flywheel vs heavy slow resistance training among athletes with patellar tendinopathy: A randomised trial. Phys Ther Sport. 2021 Nov;52:30-37. doi: 10.1016/j.ptsp.2021.08.002. Epub 2021 Aug 4.
- Individual participant dataSharing planned: No
Related trials for Patellar Tendinitis
Recruiting
Identification of Kinematic Variables Specific of Patellar Tendinopathy in Athletes at Risk
Patellar Tendinitis, Jumper's Knee
Recruiting
Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendinitis
Shock Wave Threapy for Patellar Tendinitis
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.
Vilma Campana, Dr study director
Departments of Biomedical Physics - University of Cordoba Argentina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises program for patellar tendinopathy in people with Patellar Tendinitis and Jumper's Knee, run by Universidad Nacional de Córdoba at 2 sites in Argentina.
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 6 inclusion and 4 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 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. 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?
Victorian Institute of Sports Assessment (VISA-P questionnaire) (time frame: 0 - 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 NCT03917849, which also lists 1 linked publication.
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 15 Jul 2020.