Digital Metabolic Rehab COPD

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

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.

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 12-month Digital Metabolic Rehab 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 12 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.

Web-based platform, Nutrition, Physical activity, Mindfulness, Primary care, Metabolic syndrome, COPD

The Digital Metabolic Rehab is a single-arm pilot trial that assesses Canadian Digital Technology's feasibility in preventing and managing MetS in patients living with COPD for a 12-month program.

The Digital Metabolic Rehab combines two programs: The Canadian Health Advanced by Nutrition and Graded Exercise protocol (CHANGE) and My Viva Plan (MVP). All participants receive free access to MVP and attend group video conferencing sessions with health professionals. After the 60-minute initial assessments with the dietitian and the kinesiologist, each participant has an individualized diet and exercise plan based on the intervention protocol built in MVP. Participants are split into groups of 10 based on physical ability and stage of COPD. Intervention starts in phase 1. During phase 1 (first three months), participants have weekly videoconference group sections with the kinesiologist and the dietitian and monthly with the psychologist and the respiratory therapist. Phase 2 starts from month 4 to month 12, and the video conference group sessions with health professionals are transitioned to monthly sessions.

Proportion of patients achieving reversal of Metabolic Syndrome (no longer meeting 3 of 5 diagnostic criteria)

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.

Changes in body weight will be measured using calibrated digital scale (Health o meter® Professional Remote Display, Sunbeam Products Inc., Fla., USA)

The intervention's ability to promote changes in BMI (weight and height will be combined to report BMI in kg/m^2)

Changes in fitness test are assessed using the maximum number of partial curl-ups (up to 25) and push-ups performed in one minute.

Changes in trunk flexion range of motion will be evaluated using inertial measuring units during bending in standing position.

Changes in scores of quality of life are assessed by the Chronic Respiratory Questionnaire (CRQ). The Items are scaled in Numerical, 7-point modified Likert Scale. Higher scores indicate a better health-related quality of life

Changes in physical and mental well-being are assessed in 8 domains (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health) by the Short Form 12 (SF-12).

Changes in cardiovascular disease risk by Prospective Cardiovascular Munster scores (PROCAM). PROCAM predicts cardiovascular risk in 10 years (<1% to > 40%). The higher the scores, the greater the cardiovascular risk

Changes in well-being are assessed by the World Health Organization Well-Being Index (WHO-5). The raw scores are transformed to a score from 0 to 100, with lower scores indicating worse well-being

Mental health and depression are assessed by the Patient Health Questionnaire - 9 (PHQ-9). PHQ-9 score will be obtained by adding the score for each question (total points). Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively

Physical Activity Readiness Questionnaire (PAR-Q+) will be used to assess the readiness of participants to engage in physical activity and determines any safety and possible risks that could be impacted by physical activity

Exacerbation of COPD events is measured by outpatient visits, emergency room visits, and hospitalizations

Myocardial infarction events are measured by outpatient visits, emergency room visits, and hospitalizations

Ischemic stroke events are measured by outpatient visits, emergency room visits, and hospitalizations

Inclusion Criteria: 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 Exclusion Criteria: 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