Whole-body vibration training on functional capacity, vascular function, and glycemic control in type 2 diabetes individuals with peripheral arterial disease: protocol for a randomized clinical trial

Silmara Gusso^1*Sothida Nantakool²Busaba Chuatrakoon²José Guilherme Behrensdorf Derraik¹

• ¹The University of Auckland, Auckland, New Zealand
• ²Chiang Mai University, Chiang Mai, Thailand

Background: Type 2 diabetes and peripheral arterial disease contribute to long-term disability. Walking-based exercise improves related symptoms, but adherence is limited by low fitness and leg pain. Whole body vibration stimulates muscle contractions and increases limb and microvascular blood flow which can mimic the impact of walking. Prior studies suggest improved endothelial function, reduced arterial stiffness, and lower glycated hemoglobin following vibration therapy, however its effects on functional capacity in this group remain unclear. Aims: To investigate whether whole body vibration impacts functional capacity achieved with supervised treadmill walking, as measured by incremental shuttle walk test distance with a pre specified non inferiority margin. Study design: Randomized clinical trial of 48 participants aged 50 years or older with ankle brachial index 0.9 or less or toe brachial index 0.7 or less and Fontaine stage I to IIb will be included. Participants will receive whole body vibration or supervised treadmill walking for 12 weeks, three sessions per week. Whole body vibration will be delivered using a Galileo plate. Analyses will follow intention to treat using a general linear model adjusted for age, sex, peripheral arterial disease category, diabetes duration, and baseline incremental shuttle walk test distance. Primary outcome: Distance in the incremental shuttle walks test. Secondary outcomes: Ankle brachial index, toe brachial index, brachial artery flow mediated dilation, glycated hemoglobin, SF-36 health related quality of life, and Peripheral Artery Questionnaire scores. Adverse events will be monitored. Implications for clinical practice: If efficacy is demonstrated, this intervention could serve as a clinic-based exercise option to improve mobility, vascular function, and glycemic control in this population. Trial registration: Thai Clinical Trials Registry - TCTR20251020003.