Sitting Baduanjin-based rehabilitation programme following endovascular therapy in patients with chronic limb-threatening ischemia: protocol for a WeChat mini program-assisted multicentre randomized controlled trial

Background Endovascular therapy (EVT) is an important revascularization strategy for limb salvage in patients with chronic limb-threatening ischemia (CLTI). However, despite restoration of blood flow, patients may continue to experience residual haemodynamic impairment and ischaemia-related burden after EVT, with a persistently high risk of adverse limb outcomes. Therefore, effective post-EVT rehabilitation strategies are needed to further improve limb perfusion and promote functional recovery and symptom improvement in this population. Exercise rehabilitation is widely recommended for patients with peripheral artery disease (PAD), but current evidence is largely derived from individuals with intermittent claudication, and its applicability and additional benefits in patients with CLTI after EVT remain uncertain. Sitting Baduanjin (SBDJ) is a low-intensity mind–body exercise modality that reduces lower-limb loading and postural demands while providing exercise stimulation, with potential cardiovascular regulatory effects, and may therefore be suitable for patients with limited exercise tolerance after EVT. However, evidence regarding the effects of SBDJ on target-limb haemodynamic status and patient-centred outcomes in patients with CLTI following EVT remains limited. Methods This prospective, multicentre, parallel-group randomised controlled trial incorporates blinded outcome assessment. A total of 146 eligible patients with CLTI following EVT will be randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive SBDJ combined with ankle pump exercise, whereas the control group will receive ankle pump exercise. A WeChat mini program will support exercise delivery, adherence monitoring, follow-up management, and questionnaire data collection during the home-based phase. The primary outcome is the longitudinal change in target-limb ABI over the 12-week rehabilitation period. Secondary outcomes include walking ability, quality of life, anxiety symptoms, lower-limb rest pain, and safety. Outcomes will be assessed at baseline, week 4, and week 12. Discussion This trial aims to determine whether an SBDJ-based rehabilitation programme provides additional benefits over ankle pump exercise alone on index-limb haemodynamic status among patients with CLTI following EVT, while exploring its potential effects on functional outcomes and patient-reported outcomes during the early post-EVT rehabilitation period. Clinical Trial Registration: http://itmctr.ccebtcm.org.cn/ , identifier: ITMCTR ITMCTR2022000113.