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


- candidate number10253
- NTR NumberNTR3027
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-aug-2011
- Secondary IDs37899 ABR METC slotervaart-Reade
- Public TitleComorbidity and exercise therapy in patients with knee osteoarthritis: RCT.
- Scientific TitleEvaluation of an exercise treatment strategy in patients with knee osteoarthritis and comorbidity (COOA): Randomized Clinical Trial.
- ACRONYMCOOA
- hypothesisWhat is the effect of the newly developed protocol in knee OA patients and comorbidity (coronary diseases, heart failure, diabetes type 2, obesity, Chronic Obstructive Pulmonary Disease (COPD)) on the outcome physical functioning in comparison to a waiting list group.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Chronic Obstructive Pulmonary Disease (COPD), Obesity, Heart failure, Knee, Arthrosis, Co-morbidity, Coronary artery disease
- Inclusion criteria1. 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);
3. Focus of treatment is on OA- related diability (instead of comorbidity -related disability).
- Exclusion criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2011
- planned closingdate1-jan-2014
- Target number of participants154
- InterventionsPatients in the experimental group receive treatment according to the newly developed treatmentstrategy, explicitly taking into account the comorbidity.
Prior to treatment, patients relevant goals for the treatment are established. Examples of frequently established goals are:
1. Increasing walking distance;
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 activities such as walking and stair climbing. The training modalities have been advised in the guideline for knee an hip osteoarthritis (KNGF).
During the treatment the exercise therapy will be adapted to the comorbidity in: intensity, duration and content of the therapy. This depends on present restrictions in exercise therapy, identified by the therapist during anamnesis and physical examination. The described adaptations in protocols are based on the decribed approach in the guidelines for the comorbidity. In addition to exercise therapy, education will be given about the pathology and on how to cope with it. Therapy sessions will be given once a week, during an hour or twice a week during half an hour, depending on the complexity of the diseases.
By using the protocol, the therapist is able to tailor the exercise program to the individual capacity of the patient (on a save way).

Control group:
The control group is a waiting list group. If applicable patients can receive there current medical care related to the knee complaints and/or comorbidity. The medical care will be registered. After the follow up period of 32 weeks, the patients can ralso receive the treatment according to the newly developed treatment strategy.
- Primary outcomePhysical 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 outcomeSecundary 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.
- TimepointsMeasurements will be made prior to the start of therapy (baseline), and at 10 weeks (intermediate), 20 weeks (end of intervention) and 32 weeks (follow-up).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Rooij, de
- CONTACT for SCIENTIFIC QUERIES M. Rooij, de
- Sponsor/Initiator VU University Medical Center, Reade
- Funding
(Source(s) of Monetary or Material Support)
The Royal Dutch Society for Physical Therapy (KNGF)
- PublicationsN/A
- Brief summaryOsteoarthritis (OA) is one of the diseases with the highest rate of comorbidity; rates between 68% to 85% have been reported. Comorbidity in patients with OA is associated with greater limitations in daily activities, more pain and a poor functional prognosis.

Physical therapy has been proved to be an effective intervention for patients with knee and/or hip osteoarthritis in reducing pain and improving physical functioning. Physical therapy, e.g., exercise therapy, is recommended in existing guidelines.
As comorbidity is associated with physical and psychological limitations it is important to adapt exercise therapy to the comorbidity.
In clinical practice these complex patients are often not referred for exercise therapy, or dropped out in early stage of the treatment and /or are treated inadequately: Comorbidity may restrict the possibilities for exercise therapy. Therapists often reduce the intensity of treatment to the level where it is unlikely that the treatment is effective. In existing guidelines no advice is given how exercise therapy should be adapted to comorbidity.

The purpose of the study is evaluate the effect of the newly developed protocol in knee OA patients and comorbidity (coronary diseases, heart failure, diabetes type 2, obesity, COPD) on the outcome physical functioning in comparison to waiting list group.
This study is a single-blind randomized controlled trial. Eligible patients (N=154) will be randomized while using a minimisation procedure.

The experimental group will receive 20-week exercise therapy with the newly developed treatement strategy, explicitly taking into account the comorbidity. The control group is a waiting list group. Measurements will be made prior to the start of therapy (baseline), and at 10 weeks (intermediate), 20 weeks (end of intervention) and 32 weeks (follow-up).
Patients in the experimental group receive treatment according to the newly developed treatment strategy, explicitly taking into account the comorbidity.
The following training modalities are used: aerobic exercise, strength training, training of coordination and stability, training of range of motion, training of daily activities such as walking and stair climbing. The training modalities have been advised in the guideline for knee an hip osteoarthritis (KNGF).
During the treatment the exercise therapy will be adapted to the comorbidity in: intensity, duration and content of the therapy. This depends on present restrictions in exercise therapy, identified by the therapist during anamnesis and physical examination. The described adaptations in protocols are based on the decribed approach in the guidelines for the comorbidity. In addition to exercise therapy, education will be given about the pathology and on how to cope with it. Therapy sessions will be given once a week, during an hour or twice a week during half an hour, depending on the complexity of the diseases.
By using the protocol, the therapist is able to tailor the exercise program to the individual capacity of the patient (on a save way).
Control group:
The control group is a waiting list group. If applicable patients can receive there current medical care related to the knee complaints and/or comorbidity. The medical care will be registered. After the follow up period of 32 weeks, the patients can ralso receive the treatment according to the newly developed treatment strategy.
- Main changes (audit trail)METC goedgekeurd:

Secondary outcome:
NEW
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).
- RECORD18-aug-2011 - 5-jul-2015


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