Clinical trial NCT05806294: Digital Metabolic Rehabilitation COPD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Chronic Obstructive Pulmonary Disease
Keywords: Web-based platform
Nutrition
Physical activity
Mindfulness
Primary care
Metabolic syndrome
COPD
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Revive Wellness Inc.
First posted: 2023-04-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic Syndrome
timeFrame: Change From baseline to month 3 and month 6
measure: Waist circumference
timeFrame: Change From baseline to month 3 and month 6
measure: Blood pressure
timeFrame: Change From baseline to month 3 and month 6
Secondary outcomes:
measure: Changes in body weight
timeFrame: From baseline to month 3 and month 6
measure: Changes in and body mass index (BMI)
timeFrame: From baseline to month 3 and month 6
measure: Changes in fat mass
timeFrame: From baseline to month 3 and month 6
measure: Changes in phase angle
timeFrame: From baseline to month 3 and month 6
measure: Changes in fat-free mass
timeFrame: From baseline to month 3 and month 6
measure: Changes in muscle cross sectional area
timeFrame: From baseline to month 3 and month 6
measure: Changes in muscle echogenicity
timeFrame: From baseline to month 3 and month 6
measure: Changes in muscle strength
timeFrame: From baseline to month 3 and month 6
measure: Changes in physical performance
timeFrame: From baseline to month 3 and month 6
measure: Changes in fitness assessment
timeFrame: From baseline to month 3 and month 6
measure: Changes in flexibility test
timeFrame: From baseline to month 3 and month 6
measure: Changes in resting energy expenditure
timeFrame: From baseline to month 3 and month 6
Other outcomes:
measure: Changes in quality of life parameters
timeFrame: From baseline to month 3 and month 6
measure: Changes in SF-12 score
timeFrame: From baseline to month 3 and month 6
measure: Changes in cardiovascular disease risk
timeFrame: From baseline to month 3 and month 6
measure: Well being changes
timeFrame: From baseline to month 3 and month 6
measure: Mental health
timeFrame: From baseline to month 3 and month 6
measure: Changes in psychosocial determinants of behavioral
timeFrame: From baseline to month 3 and month 6
measure: Changes in hospital admissions rates for exacerbation of COPD
timeFrame: From baseline to month 6
measure: Changes in hospital admissions rates for myocardial infarction events
timeFrame: From baseline to month 3 and month 6
measure: Changes in hospital admissions rates for ischemic stroke events
timeFrame: From baseline to month 3 and month 6
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Doug Klein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Liam Collins, MS
role: STUDY_DIRECTOR
References: