Digital Metabolic Rehabilitation COPD

NCT05806294 | Completed

• 1 other identifier: Pro00116810
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Changes in body weight

  From baseline to month 3 and month 6

• Changes in and body mass index (BMI)

  From baseline to month 3 and month 6

• Changes in fat mass

  From baseline to month 3 and month 6

• Changes in phase angle

  From baseline to month 3 and month 6

• Changes in fat-free mass

  From baseline to month 3 and month 6

Other Outcomes (9)

• Changes in quality of life parameters

  From baseline to month 3 and month 6

• Changes in SF-12 score

  From baseline to month 3 and month 6

• Changes in cardiovascular disease risk

  From baseline to month 3 and month 6

Study Arms (1)

Single-arm pilot trial

EXPERIMENTAL

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

Interventions

Digital Metabolic Rehabilitation BEHAVIORAL

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.

Single-arm pilot trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Revive Wellness Inc.: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

Related Links

• CHANGE Alberta website
• My Viva Plan website

MeSH Terms

Conditions

Metabolic Syndrome; Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Doug Klein, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Liam Collins, MS

  University of Alberta

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 10, 2023
• Study Start: November 17, 2022
• Primary Completion: July 15, 2024
• Study Completion: March 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)