Evaluation of an exercise treatment strategy in patients with knee osteoarthritis and comorbidity (COOA): Randomized Clinical Trial

Completed

Conditions: knee osteoarthritis
10023213

Registration Number: NL-OMON35594

Lead Sponsor: Koningklijk Nederlands Genootschap Fysiotherapie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 154

Inclusion Criteria

- diagnoses 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 stifness <30 minutes, crepitus, bony tenderness, bony enlargement and no palpable warmth
- at least one of the following comorbidities (diagosed by a physican), with a score *2 on the Cumulative Illness Rating Scale (ie the comorbidity has influence on daily functioning and treatment of the comorbifity is necessary): coronary heart diseases, heart failure, diabetic type 2, obesity, chronic obstructive pulmonary diseases (COPD)
- focus of treatment is on OA- related diability (instead of comorbidity -related disability)

Exclusion Criteria

- absolute contraindication for exercise therapy
- indication of knee prothesis
- refusal to sign informed consent
- insufficient control over the Dutch language
- patients with a high score of psychological distress (HADS score>11, SCL-90 score >150)
- dementia (MMSE score >26)
- suffering from significant physical limitations (possibly caused by co-morbidities) that would prohibit a patient from following the physiotherapy program.
- Patients who are expected to be lost for follow-up (e.g. because of a planned change of residency

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Physical functioning:<br /><br>Self reported physical functioning: the Western Ontario and MacMasters<br /><br>Universities Osteoarthritis Index, subscale physical functioning (WOMAC<br /><br>pf)<br /><br>Performance based test: Zes Minute Walk Test (6MWT) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary parameters in the treatment evaluation are the Time Get Up and Go<br /><br>Test, stair climbing test, knee joint proprioception,<br /><br>flexion and extension knee muscle strength, perceived global effect (9-point<br /><br>Likert scale), pain (0-10 NRS), stiffness (WOMAC),<br /><br>fatigue (VAS) en patient specific complaints checklist (PSK), HbAc1, MRC<br /><br>dyspneu, BMI.<br /><br><br /><br><br /><br>Baseline descriptives:<br /><br>Age, gender, marital status, educational level, medication use, year of<br /><br>diagnosis, comorbidity using the Cumulative Ilness Rating Scale (CIRS) and<br /><br>x-rays of the knee in standing position</p><br>