Knee OsteoarthritisPhase 2/3NCT01529398
Sensorimotor Training Versus Resistance Training in Patients With Knee Osteoarthritis
A Phase 2/3 study testing Sensorimotor training (SMT) and Resistance training (RT) in people with Knee Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
People with knee osteoarthritis (OA) have functional instability and defective neuromuscular function, it was recently suggested that sensorimotor exercises may be important and needed to improve the effectiveness of training programs for these patients. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Sensorimotor training (SMT) and Resistance training (RT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Aug 2009
- Phase
- Phase 2/3
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with tibiofemoral osteoarthritis;
- Both genders;
- Age> 50 years <75 years;
- Completion of clinical and radiological criteria of the American College of Rheumatology (ACR) criteria for knee OA;
- No physical activity in the previous 3 months;
- Education level from the 4th grade of primary school.
Who cannot join
- uncontrolled hypertension;
- decompensated diabetes mellitus;
- uncontrolled thyroid diseases;
- cardiorespiratory disease (ischemia, arrhythmia, chest pain, or exercise-induced bronchospasm), liver abnormalities;
- Patients with grade IV functional limitation that needed devices to walk(Kellgren-Lawrence radiographic classification);
- Patients in a period of sick leave by the INSS or any other related factor;
- Other rheumatic diseases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Rheumatology and Physiotherapy of Interlagos Ambulatory - Santo Amaro University
São Paulo, São Paulo, 04815-180
About this study
Official title: Efficacy of a Sensorimotor Training in Patients With Knee Osteoarthritis: a Randomized Clinical Trial
People with knee osteoarthritis (OA) have functional instability and defective neuromuscular function, it was recently suggested that sensorimotor exercises may be important and needed to improve the effectiveness of training programs for these patients. This study objective was to compare the effectiveness of a supervised resistance muscular training (RT) versus sensorimotor training (SMT) for patients with Knee OA, on decrease of pain and functional improvement.
- Conditions
- Knee Osteoarthritis
- Being tested
- Sensorimotor training (SMT), Resistance training (RT), Control group (CG)
- Keywords
- knee osteoarthritis, exercise therapy, resistance training, proprioception
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor training (SMT)Other
Also called Agility/perturbation training; proprioceptive training; neuromuscular training
The group realized 16 weeks of sensorimotor training, twice a week, with duration of 30 minutes each session. The intervention included agility and coordination exercises, perturbation training and stretching exercises. Also, the participants received orientation about the knee osteoarthritis.
Resistance training (RT)Other
The group realized 16 weeks of resistance training for the quadriceps and hamstring muscles, twice a week, with duration of 30 minutes each session. The intervention included strength leg raises, simple quadriceps and hamstring strengthening with cuff weights realized in 3 sets of ten repetition maximum(10RM) for each muscle group. The group also realized stretching exercises for lower limbs and received orientation about the knee osteoarthritis.
Control group (CG)Other
Patients in this group also received information about knee osteoarthritis and realized the same warm-up and cool-down intervention realized in the interventional groups. During 16 weeks they went to the ambulatory twice a week to perform 5 minutes of stationary bicycle and 5 minutes of stretching exercises for lower limbs.
| Study group | Role | What they receive |
|---|---|---|
| sensorimotor training (SMT) | Active comparator | Not described Receives: Other: Sensorimotor training (SMT) |
| Resistance training (RT) | Active comparator | Not described Receives: Other: Resistance training (RT) |
| Control group (CG) | Sham comparator | Not described Receives: Other: Control group (CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale of pain (VAS)
Measured: 16 weeks
Get Up and Go Test
Measured: 16 weeks
Secondary outcomes (7)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 16 weeks
electromyographic analysis of quadriceps muscle (EMG)
Measured: 16 weeks
isometric quadriceps strength
Measured: 16 weeks
Medical Outcomes Study Short Form (SF-36)
Generic, patient-report measure designed to assess health-related quality of life, comprises 36 items divided into 8 subscales.
- Physical Functioning
- Role Limitations due to Physical Problems
- General Health Perceptions
- Vitality
- Social Functioning
- Role Limitations due to Emotional Problems
- General Mental Health
- Health Transition
Measured: 16 weeks
Berg Balance Test
Measured: 16 weeks
Tinetti Test
Measured: 16 weeks
activities of daily living scale (ADLS)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startMar 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Basolli Gomiero, Federal University of São Paulo
- Investigators
- Virginia FM Trevisani, MD, MS, PhD, Study director, Federal University of São Paulo and Santo Amaro UniversityMaria S Peccin, PT, MS, PhD, Study chair, Federal University of São PauloMarcelo Abrahão, PT, Study chair, Federal University of São PauloAlvaro N Atallah, MD, PhD, Study director, Federal University of São PauloAline B Gomiero, PT, Principal investigator, Federal University of São PauloAndrea H Kayo, PT, MS, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529398
- Sponsor's protocol ID
- ABG MASTER
- Status last verified
- Feb 2012
- First submitted
- 6 Feb 2012
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fitzgerald GK, Piva SR, Gil AB, Wisniewski SR, Oddis CV, Irrgang JJ. Agility and perturbation training techniques in exercise therapy for reducing pain and improving function in people with knee osteoarthritis: a randomized clinical trial. Phys Ther. 2011 Apr;91(4):452-69. doi: 10.2522/ptj.20100188. Epub 2011 Feb 17.
PubMed 21330451Fitzgerald GK, Childs JD, Ridge TM, Irrgang JJ. Agility and perturbation training for a physically active individual with knee osteoarthritis. Phys Ther. 2002 Apr;82(4):372-82.
PubMed 11922853Diracoglu D, Aydin R, Baskent A, Celik A. Effects of kinesthesia and balance exercises in knee osteoarthritis. J Clin Rheumatol. 2005 Dec;11(6):303-10. doi: 10.1097/01.rhu.0000191213.37853.3d.
PubMed 16371799Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.
PubMed 18843657Gomiero AB, Kayo A, Abraao M, Peccin MS, Grande AJ, Trevisani VF. Sensory-motor training versus resistance training among patients with knee osteoarthritis: randomized single-blind controlled trial. Sao Paulo Med J. 2018 Jan-Feb;136(1):44-50. doi: 10.1590/1516-3180.2017.0174100917. Epub 2017 Dec 7.
PubMed 29236934
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Sensorimotor Training in Patients With Knee Osteoarthritis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01529398
- Acronym / sponsor ID
- ABG MASTER
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, exercise therapy, resistance training, proprioception
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Feb 2012 (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.
People with knee osteoarthritis (OA) have functional instability and defective neuromuscular function, it was recently suggested that sensorimotor exercises may be important and needed to improve the effectiveness of training programs for these patients. This study objective was to compare the effectiveness of a supervised resistance muscular training (RT) versus sensorimotor training (SMT) for patients with Knee OA, on decrease of pain and functional improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sensorimotor training (SMT) | Active comparator | Other: Sensorimotor training (SMT) |
| Resistance training (RT) | Active comparator | Other: Resistance training (RT) |
| Control group (CG) | Sham comparator | Other: Control group (CG) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with tibiofemoral osteoarthritis;
- Both genders;
- Age> 50 years <75 years;
- Completion of clinical and radiological criteria of the American College of Rheumatology (ACR) criteria for knee OA;
- No physical activity in the previous 3 months;
Key exclusion criteria (7 listed)
- uncontrolled hypertension;
- decompensated diabetes mellitus;
- uncontrolled thyroid diseases;
- cardiorespiratory disease (ischemia, arrhythmia, chest pain, or exercise-induced bronchospasm), liver abnormalities;
- Patients with grade IV functional limitation that needed devices to walk(Kellgren-Lawrence radiographic classification);
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 |
|---|---|---|
| Sensorimotor training (SMT)Also: Agility/perturbation training; proprioceptive training; neuromuscular trainingThe group realized 16 weeks of sensorimotor training, twice a week, with duration of 30 minutes each session. The intervention included agility and coordination exercises, perturbation training and stretching exercises. Also, the participants received orientation about the knee osteoarthritis. | Other | sensorimotor training (SMT) |
| Resistance training (RT)The group realized 16 weeks of resistance training for the quadriceps and hamstring muscles, twice a week, with duration of 30 minutes each session. The intervention included strength leg raises, simple quadriceps and hamstring strengthening with cuff weights realized in 3 sets of ten repetition maximum(10RM) for each muscle group. The group also realized stretching exercises for lower limbs and received orientation about the knee osteoarthritis. | Other | Resistance training (RT) |
| Control group (CG)Patients in this group also received information about knee osteoarthritis and realized the same warm-up and cool-down intervention realized in the interventional groups. During 16 weeks they went to the ambulatory twice a week to perform 5 minutes of stationary bicycle and 5 minutes of stretching exercises for lower limbs. | Other | Control group (CG) |
Primary outcome
Visual analogue scale of pain (VAS)
Time frame: 16 weeks
Get Up and Go Test
Time frame: 16 weeks
7 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 16 weeks
electromyographic analysis of quadriceps muscle (EMG)
Time frame: 16 weeks
isometric quadriceps strength
Time frame: 16 weeks
Medical Outcomes Study Short Form (SF-36)
Time frame: 16 weeks
Berg Balance Test
Time frame: 16 weeks
Tinetti Test
Time frame: 16 weeks
activities of daily living scale (ADLS)
Time frame: 16 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 9 Feb 2012.
- Background: PubMed 21330451Fitzgerald GK, Piva SR, Gil AB, Wisniewski SR, Oddis CV, Irrgang JJ. Agility and perturbation training techniques in exercise therapy for reducing pain and improving function in people with knee osteoarthritis: a randomized clinical trial. Phys Ther. 2011 Apr;91(4):452-69. doi: 10.2522/ptj.20100188. Epub 2011 Feb 17.
- Background: PubMed 11922853Fitzgerald GK, Childs JD, Ridge TM, Irrgang JJ. Agility and perturbation training for a physically active individual with knee osteoarthritis. Phys Ther. 2002 Apr;82(4):372-82.
- Background: PubMed 16371799Diracoglu D, Aydin R, Baskent A, Celik A. Effects of kinesthesia and balance exercises in knee osteoarthritis. J Clin Rheumatol. 2005 Dec;11(6):303-10. doi: 10.1097/01.rhu.0000191213.37853.3d.
- Background: PubMed 18843657Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.
- Derived from this study: PubMed 29236934Gomiero AB, Kayo A, Abraao M, Peccin MS, Grande AJ, Trevisani VF. Sensory-motor training versus resistance training among patients with knee osteoarthritis: randomized single-blind controlled trial. Sao Paulo Med J. 2018 Jan-Feb;136(1):44-50. doi: 10.1590/1516-3180.2017.0174100917. Epub 2017 Dec 7.
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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.
Virginia FM Trevisani, MD, MS, PhD study director
Federal University of São Paulo and Santo Amaro University
Maria S Peccin, PT, MS, PhD study chair
Federal University of São Paulo
Marcelo Abrahão, PT study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sensorimotor training (SMT) and Resistance training (RT) in people with Knee Osteoarthritis, run by Federal University of São Paulo 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 6 inclusion and 7 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 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual analogue scale of pain (VAS) (time frame: 16 weeks). 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 NCT01529398, which also lists 5 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 9 Feb 2012.