The aim of this explorative study is to develop and evaluate an exercise protocol for patients with knee and/or hip osteoarthritis and comorbidity (e.g., coronary heart diseases, heart failure, hypertension, diabetes type 2, chronic obstructive…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A process evaluation and treatment evaluation are performed in this study.
The process evaluation is based on the framework described by van Schenkman et
al. 2006. We will evaluate which adaptations have been made to the standard
treatment protocol due to co-morbidity. The form will be filled in by the
therapist at the start and at the end of the treatment process. Additionally,
after each treatment session, a registration form will be completed by the
therapist, detailing specific changes that were made concerning that session.
At the end of the treatment process, the therapist will be interviewed to
identify strengths and weaknesses in the treatment protocol and possible areas
of improvement. The patient will also be interviewed to obtain information
about treatment satisfaction, as well as possible areas of improvement in the
treatment process.
Primary outcome measures to evaluate treatment success are the Time Get Up and
Go Test and the physical functioning scale of the Western Ontario and
MacMasters Universities Osteoarthritis Index (WOMAC-pf).
Secondary outcome
Secundary parameters in the treatment evaluation are the 6-minute walking test,
stair climbing test, knee joint proprioception, flexion and extension knee
muscle strength, perceived global effect (7-point Likert scale), pain (0-10
NRS), stiffness (WOMAC), fatigue (VAS) en patient specific complaints checklist
(PSK)
Background summary
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.
Comorbidity is highly prevalent in patients with knee and/or hip
osteoarthritis. As comorbidity is associated with physical and psychological
limitations it is important to adapt exercise therapy to the comorbidity. For
example, exercise therapy for a diabetis patient should be delayed when blood
glucosis levels are equal or below 5 mmol/l. Another example is the adaptation
of exercise therapy for a patient with chronic widespread pain by using
behavioural principles.
In existing guidelines patiens with comorbidity are often excluded and no
advice is given how exercise therapy should be adapted to comorbidity.
Study objective
The aim of this explorative study is to develop and evaluate an exercise
protocol for patients with knee and/or hip osteoarthritis and comorbidity
(e.g., coronary heart diseases, heart failure, hypertension, diabetes type 2,
chronic obstructive pulmonary diseases (COPD), arthritis of the foot and hand,
low back pain, chronic pain, depression, visual/hearing impairments and
cystitis)
Study design
The present study is performed with case studies. At least 12 case studies
(with a minimum of 1 case study per comorbidity) will be performed, including
all relevant comorbidities.
Measurements for the evaluation of the treatmentprocess and the evaluation of
the treatment itself will be performed.
Evaluation of the treatment process: weekly measurements and a pre- and
posttreatment measurement.
Evaluation of the treatment itself: weekly measurements and three more
extensive measurements which will be planned at baseline, in week 12 and
immediately after the treament.
Intervention
Prior to treatment, the goals for the treatment are established which have to
be relevant for the patient. Examples of frequently established goals are: (1)
increasing walking distance (2) improving stair climbing and (3) raising from a
chair with less effort.
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 of the case studies 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. A treatment protocol was
developed for each 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 or twice a week, during half an hour or one hour, depending on
the complexity of the diseases. Treatment will be ended when the goals for
treatment have been reached or no more improvements towards these goals can be
expected.
Study burden and risks
This study will provide insight into how exercise therapy treatment can be
adapted in the presence of comorbidity, in patients with knee or hip
osteoarthritis. Patient burden is limited to the time and effort needed to
participate in the therapeutic and measurement sessions. there are no specific
risks associated with participation, as the patients will be exposed to a
treatment that is regularly provided to osteoarthritis patients within the jan
van Breemen Institute, with adaptations made specifically for the benefit of
patients with present comorbidity.
Stadsring 159b
3817 BA Amersfoort
NL
Stadsring 159b
3817 BA Amersfoort
NL
Listed location countries
Age
Inclusion criteria
- diagnosis of knee OA according to the clinical ACR criteria (33), i.e.: knee pain and at least three of the following six: age > 50 years, morning stiffness <30 minutes, crepitus, bony tenderness, bony enlargement and no palpable warmth
- diagnoses of hip OA according to the clinical ACR criteria:
Hip pain and hip internal roation < 15 degree and ESR (erythrocyte sedimentation rate (Westergren)* 45mm/hour (if ESR not available, substitute hip flexion * 115 degree) or hip internal rotation * 15 graden and pain on hip internal rotation and morning stiffness of the hip * 60 minutes and age > 50 years
- at least one of the following comorbidities (diagnosed by a physician): coronary heart diseases, heart failure, hypertension, diabetes type 2, obesitas, chronic obstructive pulmonary diseases (COPD), osteoarthritis of the foot and hand, chronic pain, chronic low back pain, depression, visual/hearing impairments and chronic cystitis
Exclusion criteria
- Indication for knee or hip prothesis
- Refusal to sign informed consent
- Not able to come to the centre for treatment
- Insufficient control over the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL30636.048.10 |