Digital Metabolic Rehabilitation COPD

April 2, 2025 updated by: University of Alberta

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Metabolic Syndrome
Time Frame: 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)
Change From baseline to month 3 and month 6
Waist circumference
Time Frame: Change From baseline to month 3 and month 6
Proportion of patients achieving reduction in waist circumference.
Change From baseline to month 3 and month 6
Blood pressure
Time Frame: 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.
Change From baseline to month 3 and month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in body weight
Time Frame: From baseline to month 3 and month 6
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)
Time Frame: From baseline to month 3 and month 6
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
Time Frame: From baseline to month 3 and month 6
Changes in fat mass (kg) by bioelectrical impedance analysis
From baseline to month 3 and month 6
Changes in phase angle
Time Frame: From baseline to month 3 and month 6
Changes in phase angle is assessed by bioelectrical impedance analysis
From baseline to month 3 and month 6
Changes in fat-free mass
Time Frame: From baseline to month 3 and month 6
Changes in fat-free mass (kg) by bioelectrical impedance analysis
From baseline to month 3 and month 6
Changes in muscle cross sectional area
Time Frame: From baseline to month 3 and month 6
Changes in muscle cross sectional area (cm2) by ultrasound
From baseline to month 3 and month 6
Changes in muscle echogenicity
Time Frame: From baseline to month 3 and month 6
Changes in muscle echogenicity by ultrasound
From baseline to month 3 and month 6
Changes in muscle strength
Time Frame: From baseline to month 3 and month 6
Changes in muscle strength assessed by handgrip strength
From baseline to month 3 and month 6
Changes in physical performance
Time Frame: From baseline to month 3 and month 6
Changes in physical performance assessed by 6-minute walk test
From baseline to month 3 and month 6
Changes in fitness assessment
Time Frame: From baseline to month 3 and month 6
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
Time Frame: From baseline to month 3 and month 6
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
Time Frame: From baseline to month 3 and month 6
Changes in resting energy expenditure assessed by indirect calorimetry
From baseline to month 3 and month 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in quality of life parameters
Time Frame: From baseline to month 3 and month 6
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
Time Frame: From baseline to month 3 and month 6
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
Time Frame: From baseline to month 3 and month 6
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
Time Frame: From baseline to month 3 and month 6
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
Time Frame: From baseline to month 3 and month 6
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
Time Frame: From baseline to month 3 and month 6
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
Time Frame: From baseline to month 6
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
Time Frame: From baseline to month 3 and month 6
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
Time Frame: From baseline to month 3 and month 6
Ischemic stroke events are measured by outpatient visits, emergency room visits, and hospitalizations
From baseline to month 3 and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Revive Wellness Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Doug Klein, MD, University of Alberta
  • Study Director: Liam Collins, MS, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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