Digital Metabolic Rehab COPD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Metabolic Syndrome, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Digital Metabolic Rehab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm pilot trial<br>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. | Behavioral: Digital Metabolic Rehab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Syndrome | Proportion of patients achieving reversal of Metabolic Syndrome (no longer meeting 3 of 5 diagnostic criteria) | Change From baseline to month 3 and month 12 | 
| Waist circumference | Proportion of patients achieving reduction in waist circumference. | Change From baseline to month 3 and month 12 | 
| Blood pressure | 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. | Change From baseline to month 3 and month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight | Changes in body weight will be measured using calibrated digital scale (Health o meter® Professional Remote Display, Sunbeam Products Inc., Fla., USA) | From baseline to month 3 and month 12 | 
| Changes in and body mass index (BMI) | The intervention's ability to promote changes in BMI (weight and height will be combined to report BMI in kg/m^2) | From baseline to month 3 and month 12 | 
| Changes in fat mass | Changes in fat mass (kg) by bioelectrical impedance analysis | From baseline to month 3 and month 12 | 
| Changes in phase angle | Changes in phase angle is assessed by bioelectrical impedance analysis | From baseline to month 3 and month 12 | 
| Changes in fat-free mass | Changes in fat-free mass (kg) by bioelectrical impedance analysis | From baseline to month 3 and month 12 | 
| Changes in muscle cross sectional area | Changes in muscle cross sectional area (cm2) by ultrasound | From baseline to month 3 and month 12 | 
| Changes in muscle echogenicity | Changes in muscle echogenicity by ultrasound | From baseline to month 3 and month 12 | 
| Changes in muscle strength | Changes in muscle strength assessed by handgrip strength | From baseline to month 3 and month 12 | 
| Changes in physical performance | Changes in physical performance assessed by 6-minute walk test | From baseline to month 3 and month 12 | 
| Changes in fitness assessment | Changes in fitness test are assessed using the maximum number of partial curl-ups (up to 25) and push-ups performed in one minute. | From baseline to month 3 and month 12 | 
| Changes in flexibility test | Changes in trunk flexion range of motion will be evaluated using inertial measuring units during bending in standing position. | From baseline to month 3 and month 12 | 
| Changes in resting energy expenditure | Changes in resting energy expenditure assessed by indirect calorimetry | From baseline to month 3 and month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Web-based platform, Nutrition, Physical activity, Mindfulness, Primary care, Metabolic syndrome, COPD