This is a study protocol and does not report results; therefore, no primary outcome data or findings are available yet.
RCT (n=48)
Open-label (no blinding possible due to intervention nature)
Computer-generated sequence with variable block sizes of 2 and 4, stratified by biological sex
No
Does whole-body vibration training improve functional capacity compared to supervised treadmill walking in individuals aged 50 years or older with type 2 diabetes and peripheral arterial disease?
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 controlled trial of 48 participants (24 per group) 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 the intention-to-treat principle 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 walk 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.
Nantakool et al. (Thu,) conducted a rct in Individuals aged ≥50 years with type 2 diabetes and peripheral arterial disease (ankle-brachial index ≤0.9 or toe-brachial index ≤0.7, Fontaine stage I to IIb) (n=48). Whole-body vibration (WBV) training vs. Supervised treadmill walking, 3 sessions/week for 12 weeks at moderate intensity with stretching was evaluated on Distance covered in the incremental shuttle walk test (ISWT). This is a study protocol and does not report results; therefore, no primary outcome data or findings are available yet.