Digital Metabolic Rehab for COPD

Overseen By Bruna Ramos da Silva, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Diabetes, Heart failure, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a digital program focused on nutrition, fitness, and mindfulness, called Digital Metabolic Rehab, can help people with COPD manage or reduce Metabolic Syndrome (MetS), a group of conditions that increase the risk of heart disease and diabetes. The goal is to determine if this program can improve the health and quality of life for those living with COPD. The trial is open to individuals diagnosed with COPD stage 1 or 2, who have been informed by their doctor that they have at least two factors of MetS, and who are comfortable using technology for self-care. As an unphased trial, this study offers a unique opportunity to explore innovative approaches to managing COPD and MetS.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Digital Metabolic Rehab program is safe for individuals with COPD?

Research has shown that digital health tools, such as the Digital Metabolic Rehab program, are generally safe for individuals with long-term health conditions. One study on similar mobile app programs found positive results. Specifically, participants demonstrated better exercise ability and improved quality of life, with no serious negative effects reported.

The program emphasizes self-care through healthy eating, exercise, and mindfulness, making it likely easy to follow. It primarily promotes healthy lifestyle changes, which typically carry low risk. However, consulting a doctor before starting any new health program is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Digital Metabolic Rehab is unique because it leverages digital technology to provide a personalized approach to managing metabolic syndrome in COPD patients. Unlike traditional treatments that primarily focus on medications and oxygen therapy, this approach uses digital tools to help patients adopt healthier lifestyle habits, potentially improving their metabolism and overall health. Researchers are excited about this trial because it explores the feasibility of using technology to empower patients in their own care, which could lead to more sustainable and effective management of COPD-related metabolic issues.

What evidence suggests that the Digital Metabolic Rehab program is effective for managing MetS in individuals with COPD?

Research has shown that digital health tools effectively manage conditions like COPD (a lung disease) and MetS (a group of risk factors that increase the chance of heart disease and other health problems). One study found that mobile apps for pulmonary rehabilitation improved exercise ability, symptom control, and quality of life. Another review demonstrated that online rehabilitation programs can be as effective as traditional, in-person sessions for managing COPD. In this trial, the Digital Metabolic Rehab program combines strategies in nutrition, fitness, and mindfulness to help manage MetS, potentially leading to better health and quality of life for those with COPD. This approach builds on the success of other digital health interventions in similar conditions. ^{1 6 7 8 9}

Who Is on the Research Team?

Doug Klein, MD

Principal Investigator

University of Alberta

Liam Collins, MS

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults over 18 with COPD stages 1 or 2 and an adjusted BMI of 26-40, who have at least two MetS factors identified by their doctor. Participants must speak English and be willing to use technology for self-care. It's not suitable for those with severe medical conditions, uncontrolled metabolic disorders, advanced heart failure, stroke history, substance abuse issues, active cancer treatment or certain diabetes complications.

Inclusion Criteria

I have mild or moderate COPD.

Your BMI is between 26 and 40 after adjustments are made.

Able to provide written informed consent in English

Exclusion Criteria

My kidney function is normal, not failing.

I do not have severe health issues like advanced COPD, heart failure, or uncontrolled diabetes.

I have diabetes with serious complications like eye, kidney issues, nerve problems, very high blood sugar, or leg pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Digital Metabolic Rehabilitation Program

Participants engage in a 6-month Digital Metabolic Rehabilitation program using the CHANGE protocol and My Viva Plan® (MVP) to guide diet and self-awareness.

6 months

Assessments at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after the program, focusing on changes in metabolic syndrome and other health parameters.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Metabolic Rehab

Trial Overview The Digital Metabolic Rehab program is being tested to see if it can help people with COPD reduce or reverse Metabolic Syndrome through nutrition, fitness, and mindfulness. The study will assess the feasibility of this preventive self-care based program in improving health outcomes.

How Is the Trial Designed?

Group I: Single-arm pilot trial Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Revive Wellness Inc.

Collaborator

Trials

3

Recruited

160+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40418567/

Effectiveness of Digital Health Interventions for Chronic ... This systematic review and meta-analysis assesses the clinical effectiveness of smartphone apps, wearable monitors, and web-delivered platforms in four COPD ...

2. mhealth.jmir.org mhealth.jmir.org/2024/1/e41753

Clinical Efficacy of Mobile App–Based, Self-Directed ... Mobile app–based pulmonary rehabilitation resulted in favorable exercise capacity, symptom score, quality of life, and hospitalization outcomes

3. nature.com nature.com/articles/s41533-024-00396-5

Web-based pulmonary telehabilitation: a systematic review This review assesses a series of studies that explore pulmonary telerehabilitation programmes delivered via web-based platforms.

4. academic.oup.com academic.oup.com/ptj/article/103/7/pzad044/7150682

Mobile Health Pulmonary Rehabilitation Compared to a ... This study aims to determine if a home-based pulmonary rehabilitation program supported by mobile health (mHealth) technology is equivalent to center-based ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0954611125003452

What is the potential role of biomarkers? A narrative review Exercise-based pulmonary rehabilitation for individuals with chronic obstructive pulmonary disease: What is the potential role of biomarkers? A narrative review.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12365816/

Digital health technologies for improving the management ... Predicting the risk of exacerbation in patients with chronic obstructive pulmonary disease using home telehealth measurement data. Artif Intell Med. (2015) ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1046202324002202

Study protocol for a single-arm pilot trial investigating the ... This study outlines the protocol for a web-based multimodal self-care program, Digital Metabolic Rehabilitation, for managing MetS in patients with COPD.

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05806294/digital-metabolic-rehabilitation-copd

Digital Metabolic Rehabilitation COPD | Clinical Research ... Study Description. It is estimated that 50% of patients with Chronic Obstructive Pulmonary Disease (COPD) are at risk for having Metabolic ...

9. withpower.com withpower.com/trial/phase-lung-diseases-10-2022-95e15

Digital Metabolic Rehab for COPD · Info for Participants This trial is for adults over 18 with COPD stages 1 or 2 and an adjusted BMI of 26-40, who have at least two MetS factors identified by their doctor.