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.
Clinically established diagnosis of type-2 diabetes for at least 12 months
Previously sedentary
Knowledgeable about hypoglycaemia
Aged over 18 years
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.
Parallel
Localized vibration
DeviceParticipants 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 interventionParticipants 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 interventionUsual care.
HBA1c (Glycated hemoglobin)
Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.
HBA1c (Glycated hemoglobin)
Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.
WHO Well-Being Index (WHO-5)
The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. A score of 0 represents the worst imaginable well-being and 100 represents the best imaginable well-being.
WHO Well-Being Index (WHO-5)
The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. A score of 0 represents the worst imaginable well-being and 100 represents the best imaginable well-being.
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is the depression module, which has nine questions ranging from "0" (not at all) to "3" (nearly every day). The scoring is interpreted as 0-4 no depression symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe depression symptoms.
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is the depression module, which has nine questions ranging from "0" (not at all) to "3" (nearly every day). The scoring is interpreted as 0-4 no depression symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe depression symptoms.
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University of Central Lancashire
Lead sponsor
University of Jazan
Collaborator
University of Hertfordshire
Collaborator
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