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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35594

Enrollment

154

Registered

2011-10-27

Start date

2011-12-13

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

knee osteoarthritis

Interventions

Patients in the experimental group receive treatment according to the newly developed treatment strategy, explicitly taking into account the comorbidity. Prior to treatment, patients relevant goals

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Physical functioning: Self reported physical functioning: the Western Ontario and MacMasters Universities Osteoarthritis Index, subscale physical functioning (WOMAC pf) Performance based test: Zes Minute Walk Test (6MWT)	—

Secondary

Measure	Time 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, perceived global effect (9-point Likert scale), pain (0-10 NRS), stiffness (WOMAC), fatigue (VAS) en patient specific complaints checklist (PSK), HbAc1, MRC dyspneu, 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	—

Measure

Time 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, perceived global effect (9-point Likert scale), pain (0-10 NRS), stiffness (WOMAC), fatigue (VAS) en patient specific complaints checklist (PSK), HbAc1, MRC dyspneu, 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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)