Longstanding Exercise Therapy in Patients with axial Spondyloarthritis

Axial Spondyloarthritis (axSpA) is a collective term for a group of chronic
inflammatory diseases, mainly characterized by arthritis of the sacroiliac
joints and spine, with back pain and stiffness as leading symptoms. In
addition, arthritis of the peripheral joints may occur, and the condition may
be associated with a variety of extraarticular manifestations involving the
eye, bowel, lungs and heart. It affects about 0.1% of the population, with men
being more often affected than women. During the course of their disease, some
patients use short, intermittent physical therapy treatment (active exercise
therapy) whereas others use longstanding weekly group exercise therapy, in
order to prevent or diminish limitations in activities or participation.
However, there is a substantial subgroup of patients with axSpA (<5 %) with
persistent high disease activity, ossification of the spine, peripheral joint
damage and/or complications of the disease or its treatment or comorbidity,
resulting in complex limitations in activities and participation. Due to the
individual nature of the problems and resulting disability, in this group the
exercise therapy treatment is currently individual, highly personalized and
usually longstanding (i.e. longer than 12 weeks and more than 20 sessions per
year). Various systematic literature reviews have concluded that overall
exercise in patients with axSpA is effective with respect to pain, aerobic
capacity, spinal mobility, muscle strength, pulmonary function, physical
functioning and quality of life (Regel 2017). Research on effectiveness of
longstanding exercise therapy in the abovementioned patient group with complex
limitations in activities and participation is however absent.

This study aims to underpin the delivery of longstanding exercise therapy in
the subgroup of patients with axSpA and complex disability.
There are 2 research questions to be addressed
1. Is longstanding, optimized active exercise therapy more effective with
respect to functional ability than usual care in patients with axSpA with
severe functional disability over a period of 52 weeks?
2. Which option (longstanding, optimized active exercise therapy or usual care)
is more cost-effective?
3. What is the long-term course of functional ability, health status and health
care consumption of patients using longstanding, optimized active exercise
therapy?

Randomised, controlled trial comparing longstanding, active exercise therapy
with usual care. After the experimental period of 52 weeks at which the primary
end-point is assessed, the intervention will be continued in the intervention
group and the effects will be monitored at follow-up measurements at 104, 156
and 208 weeks/end of study (variable follow-up duration, depending on the
moment of inclusion). At 52 weeks, the intervention will also be offered to the
patients randomized to the usual care group.

The intervention concerns longstanding, intensive active exercise therapy (52
weeks), aimed at the improvement of specific individual limitations in daily
activities and participation. It consists of a standardized program comprising
active modalities (functional exercises, aerobic exercises, muscle
strengthening and flexibility/joint range of motion exercises), with the type
of exercises, their intensity, frequency, duration, site of delivery (practice
or at home) and progression being tailored to the individual patients*
functional disability and ensuing needs and goals. The control condition
consists of care as usual, left to the discretion of the treating physicians
and the patients.

The intervention concerns exercise therapy delivered by trained primary care
physical therapists according to a standardized protocol, with no extra risks
as compared to the regular delivery of primary care exercise l therapy.
Regarding the burden, the maximum number of site visits is 4 (1 screening and 3
evaluation visits at baseline, 52 weeks (primary endpoint), and 104 weeks). The
assessments mainly consist of the completion of sets of questionnaires at home
(max. 1 hour at 7 timepoints: 0, 12, 26, 52, 104, 156 and 208 weeks) and
maximum 4 site visits with one performance test (6-minute walk test) and the
answering of a number of questions during the evaluation visits (max. total
visit duration * hour).