Effects of Vibration-Assisted Physical Activity in Type-2 Diabetes

Sponsor
University of Central Lancashire
Study ID
NCT07350473
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Localized vibration — DEVICE
    Participants allocated to the localized vibration group will complete home based sessions five times per week for 12 weeks. Each session will last approximately 60 minutes and will consist of four 10 minute bouts of focal muscle vibration separated by 5 minute seated rest periods. Participants will be seated with hips and knees at roughly 90 degrees and will perform repeated calf raises, executing plantarflexion within an approximate 0-45° range at a cadence of 60 repetitions per minute.
  • Placebo vibration — OTHER
    Participants allocated to the placebo group will follow an identical protocol to the active vibration arm, including the same session frequency, activity and durations. However, they will use a sham version of the wearable device that emits only negligible vibration, providing minimal cutaneous sensation without delivering a meaningful therapeutic dose.
  • Usual care — OTHER
    Usual care.

Study Details

The World Health Organization ranks Saudi Arabia as having the 7th highest rate of type-2 diabetes in the world. This therefore makes diabetes the most challenging health problem facing Saudi Arabia. Importantly, physical activity has been shown to improve disease symptoms and overall health in patients with type-2 diabetes. However, findings relating to the prevalence of physical inactivity in the Saudi population confirm that a sedentary lifestyle is on the rise, within physical inactivity levels in adults being 80.5%. Therefore, interventions aimed at reducing physical inactivity using bespoke modalities pertinent to Saudi Arabia are clearly warranted. There have been no fully powered, placebo-controlled trials of localised wearable calf vibration in T2DM within the Kingdom of Saudi Arabia. The proposed study will address this gap by evaluating a 12 week, home based, seated calf vibration intervention in Saudi adults with T2DM, recruited from the Jazan Diabetes and Endocrinology Center. A three-arm design will compare active localised vibration, a sham vibration condition and usual care.

Key Dates

First listed
Jan 20, 2026
Start date
Dec 1, 2026
Status verified
Feb 2026
Primary completion
Jun 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
305 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Localized Vibration
  • Sham Comparator: Placebo vibration
  • Other: Usual care

Primary Outcome Measure

HBA1c (Glycated hemoglobin) [ Time Frame: Baseline ]

Central Contacts

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