To establish the effectiveness of knee joint stabilisation exercise therapy in patients with knee osteoarthritis and knee joint instability, relative to usual-care exercise therapy
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure in this RCT is self-reported physical functioning
as assessed with the Western Ontario and McMaster Universities Osteoarthritis
Index (WOMAC). The WOMAC-pf is a commonly used questionnaire to assess the
physical functioning of patients with OA, and has been shown to be reliable,
valid and sensitive to change.
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), Irrgang*s and Felson*s self-reported knee joint
instability scales, questionnaires on rising and sitting down, walking and
stair climbing, proprioception, laxity, isokinetic muscle strength of the upper
leg (BioDex) and frontal plane alignment of the knee (goniometer). Body length
and weight will be collected at all time points to assess changes in Body Mass
Index
Background summary
Based on a biomechanical model of physical functioning in patients with
osteoarthritis of the knee, it is expected that an exercise program which
initially focuses on knee joint stabilisation, followed by muscle strengthening
and applied functional training of daily activities, is more effective in
improving the functional status of patients with OA than current exercise
programs, which are primarily aimed at muscle strengthening.
Study objective
To establish the effectiveness of knee joint stabilisation exercise therapy in
patients with knee osteoarthritis and knee joint instability, relative to
usual-care exercise therapy
Study design
This study is a single-blind randomized controlled trial. Eligible patients
will be randomized into two treatment groups: the experimental group will
receive a 12-week exercise therapy program aimed at improving the joint
stabilization process, while the control group will receive a 12-week muscle
strengthening program. Measurements will be made prior to the start of therapy
(baseline), and at 6 weeks (intermediate), 12 weeks (end of intervention) and
38 weeks (6 month follow-up).
Intervention
Experimental intervention
The experimental intervention comprises a 12-week exercise therapy program
aimed at 1) improving the knee joint stabilisation process, 2) muscle
strengthening and 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 program 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.
Control intervention
Patients in the control group will also receive a 12-week exercise therapy
program, 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
program using tailored exercises based on the information from the MACTAR
interview.
Study burden and risks
Both the experimental and control intervention comprise 24 1-hour therapeutic
sessions, in which various body functions are trained in a physically active
manner. Additionally, participants will be measured four times over a 38-week
period. These measures include both questionnaires and physical tests. Fatigue
and muscle pain may result from therapy and measurements.
During the inclusion, radiographs of the knees will be made once.
It is expected that participants in both the experimental and control group
will experience considerable helath benefits from participating in this study.
Additional to the standard diagnostic tests, an MRI-scan of the most
symptomatic knee will be made. In participants with increased risk of
complications, this scan will not be made.
Postbus 7057
1007MB Amsterdam
NL
Postbus 7057
1007MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
All potential participants* eligibility will first be assessed by a physiatrist, using the following inclusion criteria:
- 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.
- Age between 40 and 75 years
- Sufficient control of the Dutch language;Patients meeting these initial inclusion criteria will then be screened for symptoms of knee joint instability by a physical therapist. Patients are eligible for inclusion in the trial if they meet at least one of the following three criteria:
1. self-reported instability of the knee joint affecting daily functioning, as assessed with Irrgang*s knee stability questionnaire. A self-reported knee instability rating of 1 (*the symptom affects my activity slightly*) or worse is regarded to reflect knee instability affecting daily functioning
2. 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 (9;28)
3. 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 (8;27)}
Exclusion criteria
Co-morbidity which affects functional ability
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 1475 |
| CCMO | NL25349.048.08 |