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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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251020003
Enrollment
48
Registered
2025-10-20
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individuals with type 2 diabetes with peripheral artery disease. Type 2 diabetes, Peripheral artery disease, Functional capacity, Vascular function, Glycemic control.

Interventions

Whole-body vibration training will be performed three times per week for 12 weeks at a frequency ranging from 15 to 27 Hz and an amplitude of 2 to 4 mm. Each training session will last approximately
Experimental Other,Active Comparator Other
Whole-body vibration training,Walking exercise

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Be diagnosed as type 2 diabetes mellitus 2. Have a formal PAD diagnosis (17) a. ankle-brachial index (ABI) equal or less than0.9 OR b. toe-brachial index (TBI) equal or less than 0.7 AND 3. Have PAD severity I-IIb according to the Fontaine classification system, i.e., ranging from asymptomatic to severe claudication while walking AND 4. Be aged equal or greater than 50 years.

Exclusion criteria

Exclusion criteria: 1. Symptomatic chronic heart failure according to a New York Heart Association functional class of III-IV (19); 2. Recent history of cardiovascular events within the previous 6 months (e.g., myocardial infarction, stroke, thrombosis); 3. Having undergone vascular surgery within the previous 6 months; 4. Having any other medical conditions for which WBVT would not be advisable, such as benign paroxysmal positional vertigo (BPPV); 5. Currently undergoing haemodialysis; 6. Ongoing pregnancy; 7. Inability to walk independently with both feet on the floor even with the use of assistance devices (e.g., crutches, walker, or cane); 8. Lower-limb amputees; 9. Having any cognitive impairment that would preclude the patient from following the WBV protocol appropriately and for the duration of the study, or from complying with the primary outcome assessment.

Design outcomes

Primary

MeasureTime frame
Functional capacity At pre- and 12 weeks after intervention Incremental Shuttle Walk Distance in meter

Secondary

MeasureTime frame
Ankle-brachial index and Toe-brachial index At pre- and 12 weeks after intervention Ratio of blood pressure,Brachial artery flow-mediated dilation At pre- and 12 weeks after intervention Percentage of vascular diameter,Glycated hemoglobin At pre- and 12 weeks after intervention Percentage,Health-related quality of life At pre- and 12 weeks after intervention Score,Disease-specific health status At pre- and 12 weeks after intervention Score

Countries

Thailand

Contacts

Public ContactSothida Nantakool

Chiang Mai University

sothida.n@cmu.ac.th6653949246

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026