JMIR Publications

ABSTRACT

Background:

Clinical practice guidelines recommend that exercise is essential in the self-management of Ankylosing Spondylitis (AS). Attending supervised interventions requiring periodic medical center visits can be burdensome and patients may decline participation, whereas effective home-based exercise interventions that do not need regular medical center visits are likely to be more accessible for AS patients.

Objective:

To investigate the adherence, efficacy and safety of a wearable technology-assisted combined home-based exercise program in AS.

Methods:

This was a 16-week investigator-initiated, assessor-blinded, randomized, controlled trial conducted in Chinese PLA General Hospital. We enrolled patients with AS, without regular exercise habits, whose drug treatment was stable for the preceding 1 month. Patients were randomly assigned (1:1) by a computer algorithm. An exercise program consisting of moderate intensity aerobic exercise and functional exercise was given to the patients in the intervention group. The exercise intensity was controlled by a Mio FUSE Wristband which utilizes photoplethysmography to measure heart rate. Patients in the control group received usual care. The primary outcome was Ankylosing Spondylitis Disease Activity Score (ASDAS). The secondary outcomes were patient’s global assessment (PGA), physician’s global assessment (PhGA), total pain, nocturnal pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), assessment of Spondyloarthritis International Society Health Index (ASAS HI), Short Form-36 questionnaire (SF-36), estimated maximum oxygen uptake (VO2max), body composition, range of motion (ROM) of joints, and muscle endurance tests. Retention rate, adherence rate, barriers to being active and adverse events were also assessed.

Results:

Seventy-seven patients were screened, of whom 55 (71%) patients were enrolled. One patient (2%) withdrew without treatment after randomization. Twenty-six and 28 patients were respectively assigned to the intervention or control group. The median adherence rate of the prescribed exercise protocol was 84.2% (IQR, 48.7%-97.9%). For the primary outcome, between-group difference of ASDAS was significant favoring the intervention (-0.2, 95% CI, -0.4 to 0.02, P=.03). For the secondary outcomes, significant between-group differences at 16-week were detected in PGA, PhGA, total pain, BASDAI, BASDAI-fatigue, BASDAI-spinal pain, BASDAI-morning stiffness intensity, BASFI and BASMI. Moreover, the frequency of difficulty in ASAS HI-motivation at 16-week was less in the intervention group (P = 0.034). Between-group difference for change from baseline were also detected in VO2max, SF-36, back extensor endurance test and the ROM of cervical lateral flexion at 16-week. “Lack of time”, “lack of energy” and “lack of willpower” were the most distinct barriers to be active. Incidences of adverse events were similar between groups (P=.11).

Conclusions:

This technology-assisted combined home-based exercise program can improve the clinical outcomes of patients with AS compared with usual care, with good adherence and safety profile. Clinical Trial: ChiCTR1900024244