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Behavioral Intervention

Digital Metabolic Rehab for COPD

N/A

Waitlist Available

Led By Doug Klein, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

COPD stage 1 or 2

Be older than 18 years old

Must not have

Clinically significant renal failure (.i.e., creatinine > 200 µmol/L)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to month 3 and month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a digital program can help reduce the risk of Metabolic Syndrome for people living with COPD through lifestyle changes like nutrition, fitness and mindfulness.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves lifestyle modifications rather than medication, side effects may include muscle soreness from new physical activities or changes in digestion due to diet adjustments. Emotional discomfort could arise from mindfulness practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have mild or moderate COPD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is normal, not failing.

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

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I do not have any psychiatric conditions that would prevent me from following the study's requirements.

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I have a condition that makes moderate exercise difficult or unsafe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to month 3 and month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to month 3 and month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to month 3 and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure

Metabolic Syndrome

Waist circumference

Secondary study objectives

Changes in and body mass index (BMI)

Changes in body weight

Changes in fat mass

+9 more

Other study objectives

Changes in SF-12 score

Changes in cardiovascular disease risk

Changes in hospital admissions rates for exacerbation of COPD

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-arm pilot trialExperimental Treatment1 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.

0 / 5Eligibility criteria met