Effectiveness of a Biopsychosocial-Based Exercise Approach Delivered in Group and Individual Formats in Primary Sjögren Disease: A Randomized Controlled Trial.
Nazli Elif Nacar, Orkun Tufekci, Mustafa Ekici et al.
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In 30 seconds
This three-arm, parallel, single-blind randomized controlled trial evaluated a biopsychosocial exercise approach (BETY) in 60 individuals with primary Sjögren disease. Participants received group-based BETY, individually delivered BETY, or a home-based exercise control program. At 12 weeks, biopsychosocial status improved more with both group-based BETY (mean difference, -17.25; 95% CI, -28.36 to -6.13; P=.003) and individual BETY (mean difference, -19.90; 95% CI, -31.01 to -8.78; P=.001) than with control. Patient-reported Sjögren symptoms also improved in both intervention groups, and no adverse events were reported.
Key findings
- Compared with control, biopsychosocial status improved with group-based BETY (mean difference, -17.25; 95% CI, -28.36 to -6.13; P=.003).
- Individual BETY also improved biopsychosocial status versus control (mean difference, -19.90; 95% CI, -31.01 to -8.78; P=.001).
- Patient-reported Sjögren index improved in both BETY groups, with changes exceeding the minimal clinically important difference (≥1 point).
- No adverse events were reported.
Why it matters
Primary Sjögren disease can affect symptoms and wellbeing across multiple domains. This trial suggests that a structured biopsychosocial exercise approach may improve overall biopsychosocial status and patient-reported disease burden compared with home-based exercise. Similar reported benefits across group and individual delivery formats may be relevant when considering how such programmes are organised, although the findings do not establish longer-term comparative effectiveness.
What to keep in mind
The trial included 60 participants, and the 6-month follow-up was conducted only in the BETY intervention groups, limiting longer-term comparison with control.