Meniscal TearNCT02961530
Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Partial Menisectomy
A study testing Isokinetic eccentric exercises and Isotonic eccentric exercises in people with Meniscal Tear, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
A randomized clinical trial involving 32 individuals submitted to partial menisectomy will be conducted. Participants will be randomized into: Group I, submitted to a muscular rehabilitation program based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation program based on eccentric… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Meniscal Tear
- What is being tested?
- Isokinetic eccentric exercises and Isotonic eccentric exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to Dec 2017
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Young adults aged between 18 and 40 years;
- Recreational athletes;
- Unilateral partial meniscal tear;
- Partial meniscectomy by video-arthroscopy within 90 days after injury;
- Male subjects;
- Classification of body mass index up to pre-obese (25.0 - 29.9 kg / m2);
- Not undergoing any strength training program for the lower limbs in the six months prior to the study;
- Acceptance of individuals in participating in the procedures proposed by the research.
Who cannot join
- Repeated meniscal tear; Associated ligament injuries; Previous history (<6 months) of musculoskeletal lesions in the thigh; Patellar tendinopathy; Patellofemoral pain syndrome; Respiratory or cardiovascular conditions that limit the performance of exercises; Users of dietary supplements or anabolic steroids
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050170
About this study
A randomized clinical trial involving 32 individuals submitted to partial menisectomy will be conducted.
Participants will be randomized into: Group I, submitted to a muscular rehabilitation program based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 15 days after partial menisectomy. The programs will last six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.
- Conditions
- Meniscal Tear
- Being tested
- Isokinetic eccentric exercises, Isotonic eccentric exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic eccentric exercisesOther
The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality.
15 days after partial menisectomy, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isokinetic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.
Isotonic eccentric exercisesOther
The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality.
15 days after partial menisectomy, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isotonic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group 1. | Experimental | The participants randomly allocated to this arm will undergo a muscular rehabilitation program based on the isokinetic eccentric exercise for the extensor muscles of the operated knee.
The contralateral non-operated lower limb will be used as control, so it will not undergo any muscular rehabilitation program. Receives: Other: Isokinetic eccentric exercises |
| Group 2. | Active comparator | The participants randomly allocated to this arm will undergo a muscular rehabilitation program based on the isotonic eccentric exercise for the extensor muscles of the operated knee.
The contralateral non-operated lower limb will be used as control, so it will not undergo any muscular rehabilitation program. Receives: Other: Isotonic eccentric exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The femoral quadriceps muscle mass through nuclear magnetic resonance imaging
Measured: Change from baseline and six weeks after intervention protocol
Secondary outcomes (3)
Performance of knee extensors through computerized dynamometry
Measured: Change from baseline and six weeks after intervention protocol
Functionality of the individuals through Lysholm score
Measured: Change from baseline and six weeks after intervention protocol
Functionality of the individuals through single and triple hop test
Measured: Change from baseline and six weeks after intervention protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal TearStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlon Francys Vidmar, Federal University of Health Science of Porto Alegre
- Investigators
- Marlon F Vidmar, MSc, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961530
- Sponsor's protocol ID
- FUHSPortoAlegre_IV
- Status last verified
- Feb 2018
- First submitted
- 9 Nov 2016
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Partial Menisectomy
- ClinicalTrials.gov ID
- NCT02961530
- Acronym / sponsor ID
- FUHSPortoAlegre_IV
- Conditions
- Meniscal Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Nov 2016 (estimated)
- 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.
A randomized clinical trial involving 32 individuals submitted to partial menisectomy will be conducted.
Participants will be randomized into: Group I, submitted to a muscular rehabilitation program based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 15 days after partial menisectomy. The programs will last six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1. | Experimental | Other: Isokinetic eccentric exercisesThe participants randomly allocated to this arm will undergo a muscular rehabilitation program based on the isokinetic eccentric exercise for the extensor muscles of the operated knee. The contralateral non-operated lower limb will be used as control, so it will not undergo any muscular rehabilitation program. |
| Group 2. | Active comparator | Other: Isotonic eccentric exercisesThe participants randomly allocated to this arm will undergo a muscular rehabilitation program based on the isotonic eccentric exercise for the extensor muscles of the operated knee. The contralateral non-operated lower limb will be used as control, so it will not undergo any muscular rehabilitation program. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Young adults aged between 18 and 40 years;
- Recreational athletes;
- Unilateral partial meniscal tear;
- Partial meniscectomy by video-arthroscopy within 90 days after injury;
- Male subjects;
Key exclusion criteria (1 listed)
- Repeated meniscal tear; Associated ligament injuries; Previous history (<6 months) of musculoskeletal lesions in the thigh; Patellar tendinopathy; Patellofemoral pain syndrome; Respiratory or cardiovascular conditions that limit the performance of exercises; Users of dietary supplements or anabolic steroids
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 |
|---|---|---|
| Isokinetic eccentric exercisesThe individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality. 15 days after partial menisectomy, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isokinetic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours. | Other | Group 1. |
| Isotonic eccentric exercisesThe individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality. 15 days after partial menisectomy, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isotonic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours. | Other | Group 2. |
Primary outcome
The femoral quadriceps muscle mass through nuclear magnetic resonance imaging
Time frame: Change from baseline and six weeks after intervention protocol
3 secondary outcomes
Performance of knee extensors through computerized dynamometry
Time frame: Change from baseline and six weeks after intervention protocol
Functionality of the individuals through Lysholm score
Time frame: Change from baseline and six weeks after intervention protocol
Functionality of the individuals through single and triple hop test
Time frame: Change from baseline and six weeks after intervention protocol
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 9 Feb 2018.
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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.
Marlon F Vidmar, MSc principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic eccentric exercises and Isotonic eccentric exercises in people with Meniscal Tear, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 8 inclusion and 1 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 9 Feb 2018. 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 Brazil. 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?
The femoral quadriceps muscle mass through nuclear magnetic resonance imaging (time frame: Change from baseline and six weeks after intervention protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2018.