Exercise therapy in people with early-stage knee osteoarthritis: a feasibility study

There is increasing emphasis in the literature on the identification and
initiation of treatment of Osteo Arthritis (OA) in the very early stage of the
disease. Exercise therapy is the number one treatment for knee OA patients in
primary care and the effectiveness for this intervention is clear and robust.
As most studies have included patients with well-established complaints of knee
OA, the exact magnitude of the effect in a group with early-stage knee OA
remains unclear.
In an early-stage of disease, patients often report complaints periodically.
For this reason, people with early stage OA, treated or not, might hugely
recover at short-term. Defining relevant outcome measures when assessing such
early stage treatment is therefore challenging.

Therefore, with this pilot-study we will investigate which clinical outcome
will be most suitable to be used in the large-scale cost-effectiveness
Randomized Clinical Trial (RCT).

From a practical point of view, barriers might exist for both General
Practitioners (GPs), as well as for patients with regard to the early
treatment, which currently remain unknown. One important issue that needs to be
explored is the willingness of GPs to refer patients in a very early stage of
the disease to a Physiotherapist (PT) for exercise therapy.

As this is not common practice, and GPs often apply a wait-and-see strategy in
this stage of the disease, a change in daily practice is mandatory.

Therefore, the feasibility of patient recruitment should be investigated, not
only from the perspective of GPs, but also from patients: i.e. are patients in
this stage of the disease ready for a referral to a PT and will they adhere to
the prescribed intervention? Symptoms are often still mild to moderate in this
phase of the disease and will patients therefore be motivated enough to follow
an exercise program? These feasibility questions first need to be answered
before a large-scale cost-effectiveness RCT can be set up.

The general aim is to identify the relevance and feasibility of a
cost-effectiveness study on exercise therapy in patients with early stage knee
OA

1. What is the feasibility, in terms of percentage of eligible patients
recruited, for GPs to recruit patients with early-stage knee OA into a RCT of
exercise therapy compared to usual care?
2. What percentage of eligible patients are willing to participate in the study
in terms of randomization and willingness to start exercise therapy?
3. How well do participants adhere to exercise therapy (i.e. number of exercise
therapy sessions) in the intervention group?
4. What is the most suitable clinical outcome measure to be used in a future
large-scale RCT exploring the cost-effectiveness of exercise therapy compared
to usual care in patients with early-stage knee OA?

To study the feasibility of recruitment, the willingness to participate, the
compliance of the participants towards the intervention and the most suitable
outcome measure to use, we will perform a two parallel arm pilot randomized
controlled trial with a follow-up of 12 weeks.

Procedure:
We will recruit a minimum of 3 large GP practices via the academic general
practitioner network PRIMEUR. Patients who consulted their GP in the previous
12 months, or consult their GP for knee complaints during the inclusion period
will be invited to participate in the study.

In addition, potential candidates are also recruited through open recruitment
through advertisements.

They will be given information about the study and study procedures. Patient
who are willing to participate, will be randomized into the intervention
(exercise therapy by PT in addition to usual care by GP) or control (usual care
by GP) group (after informed consent and baseline measurement).
Block randomisation will be used with random blocks of 4 or 6 patients.
Blinding for subsequent treatment of patient, care provider and researcher
during follow-up will not be possible. All participants will receive two
follow-up questionnaires, after 6 and 12 weeks of follow-up.

Exercise therapy, supervised by a PT, will be performed following the
guidelines for knee OA of the Royal Dutch Society for Physiotherapy.
Physiotherapists will be trained to aim for increasing training intensity
during the treatment.

Patient selection: Patients will be selected from the medical file records of
the GPs. If interested, patients will be screened by telephone using the NICE
criteria for the diagnosis of clinical knee OA, as presently used in GP
practice.

Intervention:
Exercise therapy supervised by a PT according to a protocol based on the Dutch
guideline for physiotherapy in addition to usual care by GP.

The exercise therapy treatment will focus on strengthening, endurance and
functioning, and when needed neuromuscular balance and range of motion, and
will be tailored to the patient*s capacity. Participating PTs will be
instructed during a consensus meeting, as also was done in our previous
research projects. The exercise therapy will consist of maximal 12 treatment
sessions during the first 12-weeks of follow-up and will be administered by PTs.

Control intervention:
The control group will receive a folder with information on osteoarthritis and
what they can do themselves to decrease complaint.


Subject level:
All participants will be asked to complete a baseline questionnaire and two
follow-up questionnaires at 6 and 12 weeks follow-up. The package will raise
questions related to:
• Demographics (age, sex, height, weight, education level, ethnicity, health
literacy);
• Lifestyle (physical activity (IPAQ-S)
• Adherence of exercise therapy (EARS)
• Knee complaints (VAS pain, KOOS, PGA)
• Quality of life (EQ-5D)
• Self-efficacy for exercise (SEE).

Moreover, willingness of participation of eligible patients from the GP medical
file records will be registered.

GP level:
Registration of
• number of GPs that are willing to participate
• number of potential eligible patients per GP practice
• percentage of eligible patients that already received exercise therapy for
knee complaints

Physiotherapy level:
Registration of
• participant adherence during intervention period, including
o number of sessions and
o performance of home-exercises using a registry form

For the participants randomized to the intervention group (standard care plus
exercise therapy), the load consists of the weekly exercise therapy sessions,
the exercises at home and the completion of questionnaires three times.

The expected benefit for this group is a reduction in knee complaints, due to
muscle strengthening, such as a reduction in pain during activity, an
improvement in pain intensity, and therefore a better quality of life.

There is no direct benefit for participants randomized to the control arm
(standard care).