Improving knee joint stability in osteoarthritis with exercise therapy: does it work?|
|- candidate number||4171|
|- NTR Number||NTR1475|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-okt-2008|
|- Secondary IDs||DAA 08-1-301 Reumafonds|
|- Public Title||Improving knee joint stability in osteoarthritis with exercise therapy: does it work?|
|- Scientific Title||A randomised controlled trial of knee joint stabilisation therapy in osteoarthritis of the knee|
|- hypothesis||Exercise therapy aimed at improving the knee joint stabilisation process, followed by muscle strengthening and functional training of daily activities, is more effective than muscle strengthening exercises followed by functional training in improving physical functioning in daily activities in knee osteoarthritis patients with knee joint instability|
|- Healt Condition(s) or Problem(s) studied||Pain, Exercises, Older adults, Exercise therapy, Muscle strength, Knee, Arthrosis, Joint instability, Laxity, Proprioception|
|- Inclusion criteria||1. Diagnosis of knee OA according to the clinical ACR criteria, i.e.: knee pain and at least three of the following six: age > 50 years, morning stiffness <30 minutes, crepitus, bony tenderness, bony enlargement and no palpable warmth. |
2. Age between 40 and 75 years.
3. Sufficient control of the Dutch language.
4. At least one of the following three criteria:
* self-reported instability of the knee joint affecting daily functioning, as assessed with Fitzgerald’s knee stability questionnaire. A self-reported knee instability rating of 1 (“the symptom affects my activity mildly”) or worse is regarded to reflect knee instability affecting daily functioning
* bodyweight-adjusted isokinetic quadriceps strength of 0.8 Nm/kg or less for men or 0.55 Nm/kg or less for women, in combination with a knee joint proprioception score of 4.3° or higher, as established with the instrumented knee proprioception test
* bodyweight-adjusted isokinetic quadriceps strength of 0.8 Nm/kg or less for men or 0.55 Nm/kg or less for women, in combination with a knee joint laxity score of 4.6° or higher for men or 7.7° or higher for women, as established with the instrumented knee laxity test
|- Exclusion criteria||1. Co-morbidity which clearly affects functional ability.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2008|
|- planned closingdate||30-nov-2012|
|- Target number of participants||120|
|- Interventions||Experimental group:|
The experimental intervention comprises a 12-week exercise therapy programme aimed at:
1) improving the knee joint stabilisation process
2) muscle strengthening
3) functional training of daily physical activities.
Patients will exercise twice a week in groups of 5-6 patients led by experienced physical therapists specifically trained to provide this intervention.
In the first six weeks of exercise therapy, the focus is on improving knee joint stabilization. In the first week, low-intensity exercises with minimal joint loading are performed in the swimming pool. From the second week onwards, intensity of exercises and joint loading will be gradually increased during land-based exercise therapy sessions. These sessions comprise exercises specifically aimed at improving proprioceptive awareness (“feeling movements”), postural balance, and knee joint stability (actively minimizing the giving way, shifting or buckling of the knee) During these sessions, patients are also instructed to focus on neutral alignment of the knee (i.e., a linear alignment of hip, knee and ankle) while performing exercises. Starting in week 5, muscle strengthening exercises will be added to the programme and will gradually increase in frequency and intensity.
During the second six-week period, muscle strengthening exercises are initially dominant in the program. From week 8 onwards, the functional training of mobility-related daily activities is added to the program. Exercises will be individually tailored to specific activities indicated to be relevant and problematic by the patients themselves during a MACTAR interview at baseline.
Patients in the control group will also receive a 12-week exercise therapy programme, aimed at muscle strengthening for the first seven weeks. Exercises will gradually increase in frequency and intensity. From week 8 onwards, the functional training of mobility-related daily activities is added to the programme using tailored exercises based on the information from the MACTAR interview
|- Primary outcome||The two primary outcome measures in this RCT are observed walking and transfer ability as assessed with the Get Up and Go (GUG) test, and self-reported physical functioning as assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).|
|- Secondary outcome||A number of secondary outcome measures are included in the study, reflecting both the assessment of disabilities in specific daily activities, the patient perspective, and relevant biomechanical factors.|
These measures are:
- perceived global effect (7-point Likert scale)
- pain intensity (0-10 NRS)
- stiffness (WOMAC)
- fatigue (0-10 NRS)
- Fitzgerald’s self-reported knee joint instability scale
- isokinetic muscle strength of the upper leg (BioDex)
- frontal plane alignment of the knee (goniometer).
|- Timepoints||- December 1, 2008; official project start|
- April 1, 2009: start of inclusion period, first baseline measurements
- June, 2009: first 6-week measurements
- August, 2009: first 12-week measurements
- February 2010: first 38-week measurements
- June 2011: end of inclusion period
- August 2011: final 6-week measurements
- October 2011: final 12-week measurements
- April 2012: final 38-week measurements
- November 30, 2012: end of project
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||PhD. M.P.M. (Martijn) Steultjens|
|- CONTACT for SCIENTIFIC QUERIES||PhD. M.P.M. (Martijn) Steultjens|
|- Sponsor/Initiator ||VU University Medical Center, Jan van Breemen Instituut|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, Reumafonds, Jan van Breemen Institute|
|- Brief summary||This application concerns a study on the effectiveness of an exercise therapy programme aimed at improving knee joint stabilization in patients with osteoarthritis (OA) of the knee. Recent studies have shown that the process of knee joint stabilization is strongly related to the daily functioning of patients with OA. However, there are no treatments available that focus specifically on improving this process. Based on previous studies and a pilot study, it is expected that such a treatment programme will result in a considerable improvement in daily functioning. In the study featured in this application, two exercise therapy programs are compared. In the experimental group patients first receive therapy aimed at improving knee joint stabilization, followed muscle strengthening exercises and finally training of specific daily activities. In the control group, only muscle strengthening exercises and specific training of daily activities will be performed. Both groups receive 12 weeks of treatment.
In total 120 patients with OA and knee joint instability will participate (2x60), who will be randomized into one of the two treatment groups. Measurements will be taken prior to the start of the exercise therapy, and after 6, 12 and 38 weeks. Measurements include the assessment of daily functioning (Get Up and Go test, WOMAC questionnaire), biomechanical factors (muscle strength, laxity, joint proprioception), pain, fatigue and patient-perceived improvement.
It is expected that this study will show that the STABILO-training protocol is more effective in improving patient daily functioning than state-of-the-art exercise therapy.|
|- Main changes (audit trail)||MAIN CHANGES:|
1. Inclusion criteria: The cut-off value for lower limb muscle weakness should reflect on hamstrings strength instead of quadriceps strength;
2. Intervention: Patient Specific Complaint questionnaire will be used for individual tailoring of exercises to specific activities, in stead of MACTAR interview;
3. Primary outcome: Self-reported physical function (WOMAC) is the only primary outcome measure;
4. Secondary outcome: GUG-test is a secondary, instead of a primary outcome measure;
5. Time-points: The end of the project is prolonged to March 31 2013.
|- RECORD||3-okt-2008 - 21-dec-2011|
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