Effects of a Home-based Physical Activity Programme on Blood Biomarkers and Health-related Quality of Life Indices in Saudi Arabian Type-2 Diabetes Mellitus Patients: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 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.
The purpose of this research project is to undertake a feasibility randomised control trial, examining the effects of a 12-week home-based physical activity programme on HbA1c, blood lipids, fasting glucose and other indices of health-related quality of life in Saudi Arabian adults with type-2 diabetes.
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 hypoglycemia
- •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
Physical activity
干预措施: Physical activity (Behavioral)
Usual care
干预措施: Usual care (Other)
结局指标
主要结局
HBA1c (Glycated hemoglobin)
时间窗: 24 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.
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
- Body mass index(24 weeks)
- WHO Well-Being Index (WHO-5)(24 weeks)
- Patient Health Questionnaire-9 (PHQ-9)(24 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(24 weeks)
- Physical fitness(24 weeks)
- Fasting glucose(24 weeks)
- Diastolic blood pressure(24 weeks)
- Lipid profile(24 weeks)
- Body mass(24 weeks)
- Triglyceride-glucose index(24 weeks)
- Systolic blood pressure(24 weeks)
- Fasting glucose(Baseline)
- Systolic blood pressure(12 weeks)
- Fasting glucose(12 weeks)
- 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)
- Systolic blood pressure(Baseline)
- Diastolic blood pressure(Baseline)
- Diastolic blood pressure(12 weeks)
- Lipid profile(Baseline)
- Lipid profile(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)
研究者
Jonathan Sinclair
Research professor
University of Central Lancashire