Feasibility of a Multi Component Intervention in Patients With Severe Dyspnea and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Breathlessness
研究概览
简要总结
Researchers are trying to test the effectiveness and feasibility of a multicomponent lifestyle intervention to support weight loss decreases dyspnea in obese people with chronic lung disease and clinically significant breathlessness.
详细描述
Patient will be randomized to a 12-week intervention that uses the Weight watchers lifestyle program online, a Garmin Fitness Tracker, blue tooth scale and receive health coaching vs a wait-list control group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •BMI >=35
- •Dyspnea MRC class II or greater
- •Diagnosis of lung disease
- •Signed informed consent
排除标准
- •Pregnancy
- •Recent respiratory illness (within the last 6 weeks)
- •Recent exacerbation of chronic lung disease (within the last 6 weeks)
- •Already participating in a structured diet and/or exercise program
- •Medical contraindication to weight loss (cancer)
- •Medical contraindication to unsupervised exercise (unstable angina)
研究组 & 干预措施
Multicomponent Intervention for weight loss
12-week intervention that consists of Weight Watcher on-line program, Garmin Fitness Tracker, blue-tooth scale, and telephonic health coaching.
干预措施: Coaching and Weight Loss for patients with dyspnea (Behavioral)
Wait-list Control
The participant will receive usual care for 12 weeks and then will compassionately be offered the active intervention.
干预措施: Active Control (Behavioral)
结局指标
主要结局
Breathlessness
时间窗: baseline to 12 weeks
Chronic Respiratory Questionnaire Dyspnea
次要结局
- Daily Steps(baseline to 12 weeks)
- Disease specific quality of life(baseline to 12 weeks)
- Percent Body Fat using InBody 770 Scale(baseline to 12 weeks)
- Lean Body Mass (lbs.)using InBody 770 Scale(baseline to 12 weeks)
- Weight using InBody 770 Scale(baseline to 12 weeks)
- Skeletal Muscle Mass (lbs.) using InBody 770 Scale(baseline to 12 weeks)
- Body Mass Index using InBody 770 Scale(baseline to 12 weeks)
- Mindful Eating(baseline to 12 weeks)
- Exercise Capacity(baseline to 12 weeks)
- Sleep Efficiency(baseline to 12 weeks)
- Sleep Time Measures(baseline to 12 weeks)
- Daily Sedentary Time(baseline to 12 weeks)
- Daily Physical Activity(baseline to 12 weeks)
研究者
Roberto P. Benzo
Principal Investigator
Mayo Clinic