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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Central Lancashire

About this trial

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.

Eligibility criteria

Qualifiers

Clinically established diagnosis of type-2 diabetes for at least 12 months

Previously sedentary

Knowledgeable about hypoglycaemia

Aged over 18 years

Disqualifiers

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

Treatments tested in this trial

  • Localized vibration
  • Placebo vibration
  • Usual care

Treatment groups

305 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Central Lancashire

Lead sponsor

University of Jazan

Collaborator

University of Hertfordshire

Collaborator