Effects of Vibration-Assisted Physical Activity in Type-2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Localized vibration, Placebo vibration, Usual care.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Vibration-Assisted Physical Activity for Glycaemic Control in Type-2 Diabetes: A Randomised Controlled Trial in the Kingdom of Saudi Arabia
Overview
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.
Interventions
- 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. - 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. - Other Usual care
Usual care.
Primary outcome measures
- HBA1c (Glycated hemoglobin) [Time frame: Baseline]
- HBA1c (Glycated hemoglobin) [Time frame: 12 weeks]
Secondary outcome measures (12)
- WHO Well-Being Index (WHO-5) [Time frame: Baseline]
- WHO Well-Being Index (WHO-5) [Time frame: 12 weeks]
- Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline]
- Patient Health Questionnaire-9 (PHQ-9) [Time frame: 12 weeks]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: 12 weeks]
- Physical fitness [Time frame: Baseline]
- Physical fitness [Time frame: 12 weeks]
- Fasting glucose [Time frame: Baseline]
- Fasting glucose [Time frame: 12 weeks]
- Systolic blood pressure [Time frame: Baseline]
- Systolic blood pressure [Time frame: 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07350473 · Vibration-Assisted Physical Ac