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NCT Number: NCT07350473

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. HBA1c (Glycated hemoglobin)

    Time frame: Baseline

    Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.

  2. HBA1c (Glycated hemoglobin)

    Time frame: 12 weeks

    Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.

Secondary outcomes

  1. WHO Well-Being Index (WHO-5)

    Time frame: Baseline

    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.

  2. WHO Well-Being Index (WHO-5)

    Time frame: 12 weeks

    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.

  3. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline

    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.

  4. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 12 weeks

    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.

  5. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline

    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.

  6. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12 weeks

    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.

  7. Physical fitness

    Time frame: Baseline

    Physical fitness will be examined via the Chester Step test.

  8. Physical fitness

    Time frame: 12 weeks

    Physical fitness will be examined via the Chester Step test.

  9. Fasting glucose

    Time frame: Baseline

    Fasting glucose levels will be examined via a venous blood sample.

  10. Fasting glucose

    Time frame: 12 weeks

    Fasting glucose levels will be examined via a venous blood sample.

  11. Systolic blood pressure

    Time frame: Baseline

    Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

  12. Systolic blood pressure

    Time frame: 12 weeks

    Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

  13. Diastolic blood pressure

    Time frame: Baseline

    Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

  14. Diastolic blood pressure

    Time frame: 12 weeks

    Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

  15. Body mass

    Time frame: Baseline

    Body mass in kg measured via an electric scale.

  16. Body mass

    Time frame: 12 weeks

    Body mass in kg measured via an electric scale.

  17. Body mass index

    Time frame: Baseline

    Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.

  18. Body mass index

    Time frame: 12 weeks

    Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.

  19. Triglyceride-glucose index

    Time frame: Baseline

    The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.

  20. Triglyceride-glucose index

    Time frame: 12 weeks

    The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.

  21. Total cholesterol

    Time frame: Baseline

    This parameter will be obtained via a venous blood sample.

  22. Total cholesterol

    Time frame: 12 weeks

    This parameter will be obtained via a venous blood sample.

  23. HDL cholesterol

    Time frame: Baseline

    This parameter will be obtained via a venous blood sample.

  24. HDL cholesterol

    Time frame: 12 weeks

    This parameter will be obtained via a venous blood sample.

  25. LDL cholesterol

    Time frame: Baseline

    This parameter will be obtained via a venous blood sample.

  26. LDL cholesterol

    Time frame: 12 weeks

    This parameter will be obtained via a venous blood sample.

  27. Triglycerides

    Time frame: Baseline

    This parameter will be obtained via a venous blood sample.

  28. Triglycerides

    Time frame: 12 weeks

    This parameter will be obtained via a venous blood sample.

  29. Single Leg Stance

    Time frame: Baseline

    Static balance by recording how long a patient can stand on one leg unassisted.

  30. Single Leg Stance

    Time frame: 12 weeks

    Static balance by recording how long a patient can stand on one leg unassisted.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Sinclair, DSc

CONTACT

[email protected]

787565153

Sponsors and collaborators

Lead sponsor

University of Central Lancashire

Other

Collaborators

  • University of Hertfordshire
  • University of Jazan

Registry information

Official study title

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

Acronym: VIBRANT-KSA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 20, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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