研究目的
Establishing optimal exercise therapy using near-infrared spectroscopy monitoring of tissue muscle oxygenation after therapeutic angiogenesis for patients with critical limb ischemia.
研究成果
The trial aims to establish the safety and efficacy of optimal exercise therapy for CLI patients following therapeutic angiogenesis, potentially improving limb salvage rates and survival prognosis. The results will contribute to the evidence base for exercise therapy in CLI patients.
研究不足
The study is limited to patients with Rutherford category 4 or 5 CLI caused by ASO, and the sample size is relatively small (30 patients). The long-term effects of the exercise therapy beyond 6 months are not evaluated.
1:Experimental Design and Method Selection:
A multicenter, randomized, controlled trial to evaluate the efficacy and safety of optimal exercise therapy following therapeutic angiogenesis for CLI patients.
2:Sample Selection and Data Sources:
30 patients between 20 and 79 years with Rutherford category 4 or 5 CLI caused by ASO who will undergo therapeutic angiogenesis.
3:List of Experimental Equipment and Materials:
Near-infrared spectroscopy (NIRS) device (NIRO-200NX; Hamamatsu Photonics Co., Ltd.), treadmill, Actiwatch (Philips, N.V., USA).
4:Experimental Procedures and Operational Workflow:
Participants will be randomly allocated to receive either optimal exercise therapy or fixed exercise therapy. Optimal exercise therapy will be determined based on tissue muscle oxygenation monitoring with NIRS during exercises.
5:Data Analysis Methods:
Changes in maximum walking distance, pain-free walking distance, and other secondary endpoints will be analyzed using t-tests and Wilcoxon rank sum test.
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