Effect of a digital-based integrated exercise and sleep intervention for older adults with depression: study protocol for a stepped-wedge cluster randomized controlled trial.

Geriatric depression affects a substantial proportion of older adults globally, yet treatment rates remain critically low.

• Geriatric depression affects 12.95-28.4% of adults aged ≥ 60.
• Treatment rates remain 'critically low globally' according to the authors.
• The study targets community-dwelling older adults with depression.
• This prevalence range is cited as motivation for developing the GESO intervention.

The GESO project uses a stepped-wedge cluster-randomized trial (SW-CRT) design to evaluate a 12-week integrated exercise and sleep intervention.

• The trial is registered in the Chinese Clinical Trial Registry as ChiCTR2500107641, with a registration date of 15 August 2025.
• All eligible participants will receive the intervention during the study period, consistent with the stepped-wedge design where clusters cross over from control to intervention at different time points.
• The intervention integrates both exercise and sleep health components.
• The 12-week duration was selected for the intervention implementation.

The primary outcome of the trial is the clinical efficacy of the integrated exercise-sleep intervention in alleviating depressive symptoms.

• Mixed-effect linear regression models will be used to evaluate effects on primary and secondary outcomes.
• The study targets community-dwelling older adults with depression.
• The primary aim specifically focuses on alleviating depressive symptoms as the main clinical endpoint.

Secondary outcomes include quality of life, physical activity level, daily step count, sleep quality, anxiety symptoms, and cost-effectiveness.

• Quality of life, physical activity level, daily step count, sleep quality, and anxiety symptoms are all listed as secondary health outcomes.
• Costs will be aggregated and analyzed for economic evaluation as part of the cost-effectiveness assessment.
• The breadth of secondary outcomes reflects the integrated nature of the intervention targeting multiple lifestyle domains.

The trial will collect biological and neurological markers to assess potential mechanisms underlying the intervention's effects.

• Salivary-measured BDNF (brain-derived neurotrophic factor) and irisin levels will be collected.
• EEG-based brain function connectivity will be assessed as a potential mechanism.
• These biomarkers were selected to explore the potential underlying mechanisms by which exercise and sleep interventions may affect depression.
• BDNF and irisin are both implicated in exercise-related neurobiological pathways.

The authors hypothesize that integrated exercise and sleep interventions may exert synergistic effects on geriatric depression, though such interventions remain scarce.

• Lifestyle factors, particularly exercise and sleep, are described as demonstrating 'therapeutic potential' for geriatric depression.
• Integrated interventions targeting both exercise and sleep are described as currently 'scarce' in the literature.
• The authors propose that combining these two modalities may produce synergistic rather than merely additive effects.
• The study is described as expected to 'provide an effective and practical mode for an integrated exercise and sleep intervention among community-dwelling older adults with depression.'