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Behavioral Intervention
Digital Metabolic Rehab for COPD
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to month 3 and month 6
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have mild or moderate COPD.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood pressure
Metabolic Syndrome
Waist circumference
Secondary outcome measures
Changes in and body mass index (BMI)
Changes in body weight
Changes in fat mass
+9 moreOther outcome measures
Changes in SF-12 score
Changes in cardiovascular disease risk
Changes in hospital admissions rates for exacerbation of COPD
+6 moreTrial 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.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,127 Total Patients Enrolled
Revive Wellness Inc.UNKNOWN
2 Previous Clinical Trials
137 Total Patients Enrolled
Doug Klein, MDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
305 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have mild or moderate COPD.My kidney function is normal, not failing.I do not have severe health issues like advanced COPD, heart failure, or uncontrolled diabetes.I am 18 years old or older.I have diabetes with serious complications like eye, kidney issues, nerve problems, very high blood sugar, or leg pain.I do not have any psychiatric conditions that would prevent me from following the study's requirements.Your BMI is between 26 and 40 after adjustments are made.Your family doctor has said you have at least two out of five metabolic syndrome factors.I have a condition that makes moderate exercise difficult or unsafe.
Research Study Groups:
This trial has the following groups:- Group 1: Single-arm pilot trial
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are additional participants being solicited for this research project?
"Absolutely. According to the info presented on clinicaltrials.gov, this medical study was first published on November 17th 2022 and is actively seeking participants for recruitment. The study requires a total of 50 patients from one trial site."
Answered by AI
What purpose does this research endeavor aim to achieve?
"This evaluation has a primary focus of measuring changes in waist circumference from baseline to 3 and 12 months. Additionally, it looks into the intervention's efficacy at promoting alterations in BMI (weight-height ratio), fat mass (in kilograms), and phase angle according to bioelectrical impedance analysis."
Answered by AI
What is the total population size being studied in this research trial?
"Affirmative, according to the information hosted on clinicaltrials.gov this trial is currently recruiting participants. The listing was first made available on November 17th 2022 and it has since been updated lastly on April 7th 2023. 50 individuals need to be recruited from 1 site in total."
Answered by AI
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