Diabetes Mellitus, Type 2
Conditions
Brief summary
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
DEVICELocalized 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.
OTHERPlacebo 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.
OTHERUsual care
Usual care.
Sponsors
University of Central Lancashire
University of Jazan
University of Hertfordshire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBA1c (Glycated hemoglobin) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WHO Well-Being Index (WHO-5) | 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. |
| Patient Health Questionnaire-9 (PHQ-9) | 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. |
| Pittsburgh Sleep Quality Index (PSQI) | 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. |
| Physical fitness | Baseline | Physical fitness will be examined via the Chester Step test. |
| Fasting glucose | Baseline | Fasting glucose levels will be examined via a venous blood sample. |
| Systolic blood pressure | Baseline | Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm. |
| Diastolic blood pressure | Baseline | Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm. |
| Body mass | Baseline | Body mass in kg measured via an electric scale. |
| Body mass index | Baseline | Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature. |
| Triglyceride-glucose index | Baseline | The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices. |
| Total cholesterol | Baseline | This parameter will be obtained via a venous blood sample. |
| HDL cholesterol | Baseline | This parameter will be obtained via a venous blood sample. |
| LDL cholesterol | Baseline | This parameter will be obtained via a venous blood sample. |
| Triglycerides | Baseline | This parameter will be obtained via a venous blood sample. |
| Single Leg Stance | Baseline | Static balance by recording how long a patient can stand on one leg unassisted. |
Contacts
CONTACTJonathan Sinclair, DSc
Outcome results
None listed