Digital Metabolic Rehabilitation 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Metabolic Syndrome
• Intervention / Treatment: Behavioral: Digital Metabolic Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruna Ramos da Silva, PhD; Phone Number: 780-492-7820; Email: ramosdas@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Recruiting
      • University of Alberta
      • Contact: Bruna Ramos da Silva, PhD; Phone Number: 780-492-7820; Email: ramosdas@ualberta.ca
      • Principal Investigator: Doug Klein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single-arm pilot trial; The Digital Metabolic Rehabilitation 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 6-month program.

Behavioral: Digital Metabolic Rehabilitation; Digital Metabolic Rehabilitation 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 20 based on physical ability and stage of COPD. Intervention has 3 phases. In phase 1, weekly videoconferences with the kinesiologist and dietitian and monthly sessions with psychologist and respiratory therapist are held for the first 3 months. Phase 2 lasts from months 4 to 6 and has biweekly videoconferences with health professionals. Phase 3 starts in month 6 and has monthly group sessions with health professionals.

What is the study measuring?

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 6
Waist circumference	Proportion of patients achieving reduction in waist circumference.	Change From baseline to month 3 and month 6
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 6

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 6
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 6
Changes in fat mass	Changes in fat mass (kg) by bioelectrical impedance analysis	From baseline to month 3 and month 6
Changes in phase angle	Changes in phase angle is assessed by bioelectrical impedance analysis	From baseline to month 3 and month 6
Changes in fat-free mass	Changes in fat-free mass (kg) by bioelectrical impedance analysis	From baseline to month 3 and month 6
Changes in muscle cross sectional area	Changes in muscle cross sectional area (cm2) by ultrasound	From baseline to month 3 and month 6
Changes in muscle echogenicity	Changes in muscle echogenicity by ultrasound	From baseline to month 3 and month 6
Changes in muscle strength	Changes in muscle strength assessed by handgrip strength	From baseline to month 3 and month 6
Changes in physical performance	Changes in physical performance assessed by 6-minute walk test	From baseline to month 3 and month 6
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 6
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 6
Changes in resting energy expenditure	Changes in resting energy expenditure assessed by indirect calorimetry	From baseline to month 3 and month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life parameters	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	From baseline to month 3 and month 6
Changes in SF-12 score	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).	From baseline to month 3 and month 6
Changes in cardiovascular disease risk	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	From baseline to month 3 and month 6
Well being changes	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	From baseline to month 3 and month 6
Mental health	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	From baseline to month 3 and month 6
Changes in psychosocial determinants of behavioral	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	From baseline to month 3 and month 6
Changes in hospital admissions rates for exacerbation of COPD	Exacerbation of COPD events is measured by outpatient visits, emergency room visits, and hospitalizations	From baseline to month 6
Changes in hospital admissions rates for myocardial infarction events	Myocardial infarction events are measured by outpatient visits, emergency room visits, and hospitalizations	From baseline to month 3 and month 6
Changes in hospital admissions rates for ischemic stroke events	Ischemic stroke events are measured by outpatient visits, emergency room visits, and hospitalizations	From baseline to month 3 and month 6

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Revive Wellness Inc.
• Investigators: Principal Investigator: Doug Klein, MD, University of Alberta; Study Director: Liam Collins, MS, University of Alberta

Publications and helpful links

Helpful Links

• CHANGE Alberta website
• My Viva Plan website

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Metabolic syndrome; COPD; Primary care; Mindfulness; Nutrition; Physical activity; Web-based platform
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Respiratory Tract Diseases; Disease Attributes; Insulin Resistance; Hyperinsulinism; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Metabolic Syndrome
• Other Study ID Numbers: Pro00116810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No