Strength Training Regimen for Normal Weight Diabetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c across study visits
研究概览
简要总结
The Strength Training Regimen in Normal Weight Diabetics (STRONG-D) study will examine the effectiveness of different exercise regimen types in controlling diabetes for the normal weight type 2 diabetes population.
详细描述
In the STRONG-D study, participants are randomly assigned to strength training, aerobic training or a combined strength and aerobic training group. Participants in the exercise group will attend exercise sessions over the course of 9 months at the YMCA. Participants will have opportunities to engage in other activities such as educational run-in visits that will allow for measurement of hemoglobin A1c and emphasize the importance of exercise in improving 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
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent hemoglobin A1c result between 6.5%-13%
- •Diagnosis of Type 2 Diabetes Mellitus
- •BMI between 18.5 -25 kg/m2
- •Blood pressure < 160/100
- •Sedentary lifestyle
- •Able and willing to enroll and meet requirements of the study
排除标准
- •Age less than 30 years or greater than 75 years
- •Type 1 diabetes or use of insulin pump
- •Triglycerides >500 mg/dL
- •Use of weight loss medication
- •Bariatric surgery
- •Consumes >14 alcoholic drinks per week
- •Pregnancy
- •Plans to be away for more than four weeks
- •Medical conditions which would prevent long-term participation or which would contraindicate physical activity
研究组 & 干预措施
Combination (Strength and Aerobic) Training
Participants in the combination (strength and aerobic training) group will take part in a 9-month exercise intervention at a local exercise facility. They will engage aerobic training that will expend 10 kcal/kg/week in combination with strength-training, 3 days per week.
干预措施: Exercise Intervention (Behavioral)
Strength Training Only
Participants in the strength-training only group will take part in a 9-month exercise intervention at a local exercise facility. They will engage in strength training 3 days per week for approximately 60 minutes each exercise session.
干预措施: Exercise Intervention (Behavioral)
Aerobic Training Only
Participants in the aerobic training only group will take part in a 9-month exercise intervention at a local exercise facility. They will engage in aerobic training over 3 -5 days per week to achieve the targeted dose of 12 kcal/kg per week at a training intensity between 50-80% VO2 max.
干预措施: Exercise Intervention (Behavioral)
结局指标
主要结局
Change in Hemoglobin A1c across study visits
时间窗: Baseline, monthly (for 9 months), 9-Months
次要结局
- Changes in cardiorespiratory fitness, as measured by 6-minute walk test(Baseline, 9-Months)
- Change in quality of life(Baseline, 9-Months)
- Change in body composition across study visits, as measured using DEXA(Baseline, 9-Months)
- Change in body weight across study visits(Baseline, 9-Months)
- Change in waist circumference across study visits(Baseline, 9-Months)
- Change in blood pressure across study visits(Baseline, 9-Months)
- Change in muscle strength and endurance, as measured by Biodex strength testing(Baseline, 9-Months)
- Change in Dietary Intake, as measured by Food Frequency Questionnaire(Baseline, 9-Months)
研究者
Latha Palaniappan, MD, MS
Professor
Stanford University