Efficacy of Whole-body Electromyostimulation (WB-EMS) Training on Glycemic Control in People With Prediabetes: a Randomized Controlled Pilot-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change from baseline in HbA1c in %
研究概览
简要总结
The goal of this pilot study is to assess the efficacy of the intervention (WB-EMS Training) in a sedentary group of adults with pre-diabetes and to estimate the potential effect sizes.
The main goals and questions it aims to answer are:
- Efficacy WB-EMS training in sedentary adults with pre-diabetes,
- Has WB-EMS training positive effects on HbA1c and other biomarkers?
Researchers will compare the intervention group with two control groups to see if WB-EMS training has effects on pre-diabetes.
详细描述
The study is planned as a randomized controlled pilot study. The intervention phase duration is set to 16 weeks. Prior to the study start, all subjects will be screened for their eligibility according to defined inclusion and exclusion criteria.
Sixty eligible sedentary individuals with pre-diabetes between the ages of 40 and 65 years will be randomised to one intervention group (n=20) and two control groups (n=20 each).
The main exercise intervention will be conducted via WB-EMS using a medical device approved system (miha bodytec®, Type II, Gersthofen, Germany). Participants in the intervention and one control group will receive an activity tracker (vivosmart 5, Garmin) to measure daily steps during the 16-week intervention phase. All study groups will further receive an evidence-based lifestyle education programme (6 x 20 minutes for 3 months), which provides education, information, and advice to prevent disease progression and improve quality of life and mobility.
During the baseline visit and after 16 weeks endpoint measurements incl. blood biomarkers, cardiometabolic and body composition parameters will be assessed. The intervention group will additionally attend a follow-up visit after 32 weeks and the parameters will be assessed again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •community-dwelling sedentary (<20 min physical activity on <3 days/week) men and women aged 40-65 years without Diabetes Type 2
- •elevated HbA1c levels (5.7%-6.4%),
- •not functionally impaired (Short Physical Performance Battery (SPPB) ≥10)
- •signed informed consent
- •consent to use the WB-EMS and activity tracker
排除标准
- •high-grade arrhythmia/VHF/SM carriers, heart failure >NYHA2, nephropathy (GFR<60),
- •cognitive impairment
- •Diabetes Type 2
结局指标
主要结局
Change from baseline in HbA1c in %
时间窗: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Assessed via blood sample with finger stick technique
次要结局
- Change from baseline in depressive symptoms(Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group))
- Change from baseline in well-being(Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group))
- Change from baseline in body composition(Baseline, after 16 weeks of intervention and after follow-up 32 weeks (only intervention group))
- Change from baseline in lipid profile in mg/dL(Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group))
- Change from baseline in waist circumference in cm(Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group))
- Change from baseline in health-related quality of life(Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group))
- Change from baseline in stress(Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group))
研究者
Dr. Mahdieh Shojaa
Principal Investigator
University Hospital Tuebingen