Effects of Vibration-Assisted Physical Activity in Type-2 Diabetes (VIBRANT-KSA)

University of Central Lancashire

Status: Begins enrollment in 9 months

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Localized vibration; Other: Usual care; Other: Placebo vibration

Study type: Interventional

Funder types: Other

Identifiers

NCT07350473

Vibration-Assisted Physical Ac

Details and patient eligibility

About

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.

Enrollment: 305 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically established diagnosis of type-2 diabetes for at least 12 months
• Previously sedentary
• Knowledgeable about hypoglycaemia
• Aged over 18 years
• Capacity to give informed consent.

Exclusion criteria

• Cognitive impairment precluding consent or participation
• Pregnancy
• Additional medical conditions that prevent safe physical activity (e.g. severe arthritis or advanced heart failure)
• Enrolment in any other clinical trial designed to influence type-2 diabetes symptoms.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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305 participants in 3 patient groups

Localized Vibration

Experimental group

Treatment:

Device: Localized vibration

Placebo vibration

Sham Comparator group

Treatment:

Other: Placebo vibration

Usual care

Other group

Treatment:

Other: Usual care