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

Vibration-Assisted Physical Activity for Glycaemic Control in Type-2 Diabetes: A Randomised Controlled Trial in the Kingdom of Saudi Arabia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Usual care; Device: Localized vibration; Other: Placebo vibration

• Study Type: Interventional
• Enrollment (Estimated): 305
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Sinclair, DSc; Phone Number: 787565153; Email: jksinclair@lancashire.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care	Other: Usual care; Usual care.
Experimental: Localized Vibration	Device: Localized vibration; 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.
Sham Comparator: Placebo vibration	Other: Placebo vibration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	12 weeks
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.	Baseline
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.	12 weeks
Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.	Baseline
Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.	12 weeks
Physical fitness	Physical fitness will be examined via the Chester Step test.	Baseline
Physical fitness	Physical fitness will be examined via the Chester Step test.	12 weeks
Fasting glucose	Fasting glucose levels will be examined via a venous blood sample.	Baseline
Fasting glucose	Fasting glucose levels will be examined via a venous blood sample.	12 weeks
Systolic blood pressure	Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.	Baseline
Systolic blood pressure	Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.	12 weeks
Diastolic blood pressure	Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.	Baseline
Diastolic blood pressure	Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.	12 weeks
Body mass	Body mass in kg measured via an electric scale.	Baseline
Body mass	Body mass in kg measured via an electric scale.	12 weeks
Body mass index	Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.	Baseline
Body mass index	Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.	12 weeks
Triglyceride-glucose index	The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.	Baseline
Triglyceride-glucose index	The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.	12 weeks
Total cholesterol	This parameter will be obtained via a venous blood sample.	Baseline
Total cholesterol	This parameter will be obtained via a venous blood sample.	12 weeks
HDL cholesterol	This parameter will be obtained via a venous blood sample.	Baseline
HDL cholesterol	This parameter will be obtained via a venous blood sample.	12 weeks
LDL cholesterol	This parameter will be obtained via a venous blood sample.	Baseline
LDL cholesterol	This parameter will be obtained via a venous blood sample.	12 weeks
Triglycerides	This parameter will be obtained via a venous blood sample.	Baseline
Triglycerides	This parameter will be obtained via a venous blood sample.	12 weeks
Single Leg Stance	Static balance by recording how long a patient can stand on one leg unassisted.	Baseline
Single Leg Stance	Static balance by recording how long a patient can stand on one leg unassisted.	12 weeks

Collaborators and Investigators

• Sponsor: University of Central Lancashire
• Collaborators: University of Hertfordshire; University of Jazan

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Vibration-Assisted Physical Ac

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No