Comorbidity and exercise therapy in patients with knee osteoarthritis: RCT.

Conditions: Knee Osteoarthritis, comorbidity:coronary diseases, heart failure, diabetes type 2, obesity, COPD) knieartrose, comorbiditeit: coronairlijden, hartfalen, diabetes type 2, obesitas, COPD)

Registration Number: NL-OMON29050

Lead Sponsor: VU medical centre, Amsterdam, the NetherlandsReade, centrum voor Revalidatie en Reumatologie, Amsterdam, the Netherlands

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 154

Inclusion Criteria

1. Diagnoses of knee OA according to the clinical ACR criteria, i.e: knee pain and at least htree of the following six: age > 50 years, morning stifness <30 minutes, crepitus, bony tenderness, bony enlargement and no palpable warmth;

2. At least one of the following comorbidities (diagosed by a physican), with a score ≥2 on the Cumulative Illness Rating Scale (ie influence of the comorbidity on daily functioning and treatment of the comorbifity is necessary): Coronary heart diseases, heart failure, diabetic type 2, obesity, chronic obstructive pulmonary diseases (COPD);

Exclusion Criteria

1. Absolute contraindication for exercise therapy;

2. Indication of knee prothesis;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical functioning:<br /><br>1. Self reported physical functioning: The Western Ontario and MacMasters Universities Osteoarthritis Index, subscale physical functioning (WOMAC pf);<br /><br>2. Performance based test: Six Minute Walk Test (6MWT).

Secondary Outcome Measures

Name	Time	Method
Secundary parameters in the treatment evaluation are the Time Get Up and Go Test, stair climbing test, knee joint proprioception, flexion and extension knee muscle strength, Range of motion of the knee (flexion and extension), perceived global effect (9-point Likert scale), pain (Numeric Rating Scale 0-10 (NRS)), pain (WOMAC), stiffness (WOMAC), fatigue (NRS 0-10), Patient Specific Functioning Scale (PSFS), Frailty Index, LASA Physical Activity Questionnaire (LAPAQ), Rand Short Form (SF36), HbAc1 mmol/mol, Medical Research Council (MRC) dyspnoea Scale, Body Mass Index (BMI).<br /><br /><br>Baseline descriptives:<br /><br>Age, gender, marital status, educational level, medication use, year of diagnosis, comorbidity using the Cumulative Ilness Rating Scale (CIRS) and x-rays of the knee in standing position.