Behavioral Intervention and Home-based Resistance Training to Increase Physical Activity and Muscle Strength in Patients With Type 2 Diabetes: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Physical Activity
研究概览
简要总结
The purpose of this study is to compare motivational interviews and self-efficacy theory-based exercise behavior and home-based resistance exercise (elastic band to non-elastic band) to improve physical activity, muscle strength, body composition, and self-efficacy of exercise in type 2 diabetic patients. The effectiveness of performance and exercise compliance.
详细描述
This study adopts an experimental research design. A total of 90 cases of type 2 diabetes who are not exercising regularly are recruited from the outpatient clinic of the Metabolism Department of a medical center in the north to participate in the study. Blocks 6, and 12 (Block) are randomly assigned. The research subjects were assigned to the behavior change and resistance exercise group, and home-based resistance exercise( with elastic band), and the control group. The behavior changes and resistance exercise group received motivational interviews and self-efficacy theory-based exercise behavior changes and resistance exercise guidance intervention, home resistance exercise. the group received home elastic band resistance exercise training, and the control group received regular exercise guidance. The three groups received data collection of physical activity, muscle strength, body composition, physical activity function, and exercise self-efficacy in the pre-test, the sixth week, and the twelfth week. During the study period, the exercise log was used to collect the mediating variable about exercise compliance (Time × frequency) data collection. This study compares the effectiveness of motivational interviews and self-efficacy theory-based exercise behavior intervention and home resistance exercise training programs. The result will show an empirical evidence for type 2 diabetic patients to increase physical activity and muscle strength in the future, and will also apply to training of muscle strengthening in diabetes and other chronic disease.
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 (Outcomes Assessor)
盲法说明
single
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes type 2
- •age >50 years old
- •sedentary lifestyle (PASE questionnaire leisure time physical activities score female <30 points, male <40 points)
排除标准
- •severe congestive heart failure (New York Heart Association Functional Class III and IV)
- •severe renal failure (estimated Glomerular Filtration Rate < 15 mL/min/1.73m2)
- •stroke ((The National Institutes of Health Stroke Scale > 15)
- •Peripheral Arterial Occlusive Disease
- •Foot ulcer over 6 month
- •Severe muscle diseases and rheumatoid arthritis
- •Cognitive or mental disorders who cannot understand and cooperate with the exercise plan
- •those who are accessed by the doctor to be avoided for exercise
结局指标
主要结局
Physical Activity
时间窗: Change from Baseline to 12 weeks
Physical activity measured leisure-time physical activity for 7 days by Physical Activity Scale for the Elderly (PASE).PASE was self-administered occupational, household, and leisure physical activities. Participants were asked about the intensity, frequency, and duration of a variety of activities, including walking; strenuous, moderate, and light sports; muscle strength and endurance; occupational activities that included standing or walking; lawn work and gardening; caring for another person; home repairs; and heavy and light housework over the previous 7 days. The frequency and duration of each activity were multiplied by an empirically derived item weight and summed to compute the total PASE score activity.15 The PASE questions work-related, household, and leisure time activities for the 7 days preceding the interview. The score is continuous, ranges from 0 to 793, and higher values indicate a more active individual.
次要结局
- Hand Grip Strength(kg)(Change from Baseline to 12 weeks)
- Body Composition(Change from Baseline to 12 weeks)
- Self-efficacy(Change from Baseline to 12 weeks)
- Physical Performance_30-s Chair Stand Test.(Change from Baseline to 12 weeks)
- Hemoglobin A1c(Change from Baseline to 12 weeks)
- Physical Performance _6-meter Walking Speed.(Change from Baseline to 12 weeks)
研究者
Tsae Jyy, Wang
Professor
National Taipei University of Nursing and Health Sciences