Utilizing Canadian Digital Technology to Prevent and Manage Diabetes, Obesity, and Heart Disease in Patients Living With Congestive Obstructive Pulmonary Disease - A Single-arm Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Metabolic Syndrome
研究概览
简要总结
People with Chronic Obstructive Pulmonary Disease (COPD) are at greater risk for Metabolic syndrome (MetS). Although the management of MetS will not cure COPD, it can beneficially impact health outcomes and quality of life through lifestyle modifications. The study aims to determine if using the Digital Metabolic Rehab program, which is based on preventive self-care and includes three key pillars of health: nutrition, fitness, and mindfulness, will be feasible to reduce or reverse MetS for individuals living with COPD.
详细描述
It is estimated that 50% of patients with Chronic Obstructive Pulmonary Disease (COPD) are at risk for having Metabolic Syndrome (MetS). While COPD is incurable, MetS can be reduced by diet and exercise. Yet, the evidence shows that lifestyle interventions with the self-management of health at home are low. Thus, the Canadian Health Advanced by Nutrition and Graded Exercise (CHANGE) protocol and My Viva Plan® (MVP) were created. CHANGE protocol is a personalized approach to nutrition and exercise modification supported by an interprofessional team in primary care settings. MVP is a digital Canadian self-care treatment program encompassing nutrition, fitness, and mindfulness. The investigators propose a 6-month Digital Metabolic Rehabilitation program using CHANGE protocol + MVP to guide diet and self-awareness in 50 individuals diagnosed with COPD and MetS. Assessments and measurements will be completed at baseline, 3 and 6 months. The study aims to determine the impact of the CHANGE protocol + MVP on reducing or reversing MetS for individuals living with COPD. This study will inform whether the Digital Metabolic Rehab program directly impacts health and wellness among patients with COPD and could become an essential tool for virtual, preventative self-care delivery in primary care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Adult patients (18+)
- •COPD stage 1 or 2
- •Identified by their family doctor as having at least two out of five MetS factors
- •Adjusted body mass index (BMI) between 26 to 40
- •Able to provide written informed consent in English
排除标准
- •Inability to speak, read or understand English
- •Having a medical or physical condition that makes moderate-intensity physical difficult or unsafe
- •Diagnosis of Type 1 diabetes mellitus or type 2 diabetes mellitus with proliferative diabetic retinopathy, nephropathy (serum creatine > 160 µmol/L), clinically significant neuropathy (defined as absent ankle jerks), severe hyperglycemia (fasting blood glucose > 11 mmol/L), or claudication symptoms
- •Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), COPD stages 3 or 4, heart failure stage D, stroke, and ongoing substance abuse, undergoing active treatment for cancer
- •Clinically significant renal failure (.i.e., creatinine > 200 µmol/L)
- •Diagnosis of psychiatric disorders that would limit the adequate ability to comply with the study protocol
- •Unable or unwilling to use technology to meet with the healthcare team and My Viva Plan to manage self-care
结局指标
主要结局
Metabolic Syndrome
时间窗: Change From baseline to month 3 and month 6
Proportion of patients achieving reversal of Metabolic Syndrome (no longer meeting 3 of 5 diagnostic criteria)
Waist circumference
时间窗: Change From baseline to month 3 and month 6
Proportion of patients achieving reduction in waist circumference.
Blood pressure
时间窗: Change From baseline to month 3 and month 6
Proportion of patients achieving reduction in systolic and diastolic blood pressure. Systolic and diastolic blood pressure will be measured using a standard semi-automatic sphygmomanometer.
次要结局
- Changes in fat mass(From baseline to month 3 and month 6)
- Changes in phase angle(From baseline to month 3 and month 6)
- Changes in body weight(From baseline to month 3 and month 6)
- Changes in and body mass index (BMI)(From baseline to month 3 and month 6)
- Changes in fat-free mass(From baseline to month 3 and month 6)
- Changes in muscle cross sectional area(From baseline to month 3 and month 6)
- Changes in muscle echogenicity(From baseline to month 3 and month 6)
- Changes in flexibility test(From baseline to month 3 and month 6)
- Changes in muscle strength(From baseline to month 3 and month 6)
- Changes in physical performance(From baseline to month 3 and month 6)
- Changes in resting energy expenditure(From baseline to month 3 and month 6)
- Changes in fitness assessment(From baseline to month 3 and month 6)
研究者
Doug Klein
Professor at the Department of Family Medicine
University of Alberta