Vibration-Assisted Physical Activity for Glycaemic Control in Type-2 Diabetes: A Randomised Controlled Trial in the Kingdom of Saudi Arabia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 305
- 主要终点
- HBA1c (Glycated hemoglobin)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Localized Vibration
干预措施: Localized vibration (Device)
Placebo vibration
干预措施: Placebo vibration (Other)
Usual care
干预措施: Usual care (Other)
结局指标
主要结局
HBA1c (Glycated hemoglobin)
时间窗: 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.
HBA1c (Glycated hemoglobin)
时间窗: 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.
次要结局
- WHO Well-Being Index (WHO-5)(Baseline)
- WHO Well-Being Index (WHO-5)(12 weeks)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline)
- Patient Health Questionnaire-9 (PHQ-9)(12 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline)
- Pittsburgh Sleep Quality Index (PSQI)(12 weeks)
- Physical fitness(Baseline)
- Physical fitness(12 weeks)
- Fasting glucose(Baseline)
- Fasting glucose(12 weeks)
- Systolic blood pressure(Baseline)
- Systolic blood pressure(12 weeks)
- Diastolic blood pressure(Baseline)
- Diastolic blood pressure(12 weeks)
- Body mass(Baseline)
- Body mass(12 weeks)
- Body mass index(Baseline)
- Body mass index(12 weeks)
- Triglyceride-glucose index(Baseline)
- Triglyceride-glucose index(12 weeks)
- Total cholesterol(Baseline)
- Total cholesterol(12 weeks)
- HDL cholesterol(Baseline)
- HDL cholesterol(12 weeks)
- LDL cholesterol(Baseline)
- LDL cholesterol(12 weeks)
- Triglycerides(Baseline)
- Triglycerides(12 weeks)
- Single Leg Stance(Baseline)
- Single Leg Stance(12 weeks)
研究者
Jonathan Sinclair
Professor
University of Central Lancashire