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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29050
Enrollment
154
Registered
2011-08-18
Start date
2011-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Patients in the experimental group receive treatment according to the newly developed treatmentstrategy, explicitly taking into account the comorbidity. Prior to treatment, patients relevant goals f
2. Improving stair climbing. The following training modalities are used: aerobic exercise, strength training, training of coordination and stability, training of range of motion, training of daily ac

Sponsors

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

Eligibility

Inclusion criteria

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 &#8805;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); 3. Focus of treatment is on OA- related diability (instead of comorbidity -related disability).

Exclusion criteria

Exclusion criteria: 1. Absolute contraindication for exercise therapy; 2. Indication of knee prothesis; 3. Refusal to sign informed consent; 4. Insufficient control over the Dutch language; 5. Patients with a high score of psychological distress (HADS score>11, SCL-90 score >150); 6. Dementia (MMSE score >26); 7. Suffering from significant physical limitations (possibly caused by co-morbidities) that would prohibit a patient from following the physiotherapy program; 8. Patients who are expected to be lost for follow-up (e.g. because of a planned change of residency.

Design outcomes

Primary

MeasureTime frame
Physical functioning: 1. Self reported physical functioning: The Western Ontario and MacMasters Universities Osteoarthritis Index, subscale physical functioning (WOMAC pf); 2. Performance based test: Six Minute Walk Test (6MWT).

Secondary

MeasureTime frame
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). Baseline descriptives: 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.

Contacts

Public ContactM. Rooij, de

dr. Jan van Breemenstraat 2

m.d.rooij@reade.nl+31 (0)20 5896291

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)