Metabolic SyndromeNCT05806294
Digital Metabolic Rehabilitation COPD
A study testing Digital Metabolic Rehabilitation in people with Metabolic Syndrome and Chronic Obstructive Pulmonary Disease, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Digital Metabolic Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Digital Metabolic Rehabilitation
- Keywords
- Web-based platform, Nutrition, Physical activity, Mindfulness, Primary care, Metabolic syndrome, COPD
- Medical subject headings
- Metabolic Syndrome, Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Metabolic RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital Metabolic Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Syndrome
Proportion of patients achieving reversal of Metabolic Syndrome (no longer meeting 3 of 5 diagnostic criteria)
Measured: Change From baseline to month 3 and month 6
Waist circumference
Proportion of patients achieving reduction in waist circumference.
Measured: 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.
Measured: Change From baseline to month 3 and month 6
Secondary outcomes (12)
Changes in body weight
Changes in body weight will be measured using calibrated digital scale (Health o meter® Professional Remote Display, Sunbeam Products Inc., Fla., USA)
Measured: From baseline to month 3 and month 6
Changes in and body mass index (BMI)
The intervention's ability to promote changes in BMI (weight and height will be combined to report BMI in kg/m^2)
Measured: From baseline to month 3 and month 6
Changes in fat mass
Changes in fat mass (kg) by bioelectrical impedance analysis
Measured: From baseline to month 3 and month 6
Changes in phase angle
Changes in phase angle is assessed by bioelectrical impedance analysis
Measured: From baseline to month 3 and month 6
Changes in fat-free mass
Changes in fat-free mass (kg) by bioelectrical impedance analysis
Measured: From baseline to month 3 and month 6
Changes in muscle cross sectional area
Changes in muscle cross sectional area (cm2) by ultrasound
Measured: From baseline to month 3 and month 6
Changes in muscle echogenicity
Changes in muscle echogenicity by ultrasound
Measured: From baseline to month 3 and month 6
Changes in muscle strength
Changes in muscle strength assessed by handgrip strength
Measured: From baseline to month 3 and month 6
Changes in physical performance
Changes in physical performance assessed by 6-minute walk test
Measured: From baseline to month 3 and month 6
Changes in fitness assessment
Changes in fitness test are assessed using the maximum number of partial curl-ups (up to 25) and push-ups performed in one minute.
Measured: From baseline to month 3 and month 6
Changes in flexibility test
Changes in trunk flexion range of motion will be evaluated using inertial measuring units during bending in standing position.
Measured: From baseline to month 3 and month 6
Changes in resting energy expenditure
Changes in resting energy expenditure assessed by indirect calorimetry
Measured: From baseline to month 3 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start17 Nov 2022
- Primary completion15 Jul 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Revive Wellness Inc.
- Responsible party
- Sponsor
- Investigators
- Doug Klein, MD, Principal investigator, University of AlbertaLiam Collins, MS, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806294
- Sponsor's protocol ID
- Pro00116810
- Status last verified
- Apr 2025
- First submitted
- 3 Mar 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05806294
- Acronym / sponsor ID
- Pro00116810
- Keywords
- Web-based platform, Nutrition, Physical activity, Mindfulness, Primary care, Metabolic syndrome, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Revive Wellness Inc.
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm pilot trial | Experimental | Behavioral: Digital Metabolic RehabilitationThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Metabolic RehabilitationDigital 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. | Behavioural | Single-arm pilot trial |
Primary outcome
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)
Waist circumference
Time frame: Change From baseline to month 3 and month 6
Proportion of patients achieving reduction in waist circumference.
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.
12 secondary outcomes
Changes in body weight
Time frame: 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
Changes in fat mass
Time frame: From baseline to month 3 and month 6
Changes in phase angle
Time frame: 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 muscle cross sectional area
Time frame: 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 strength
Time frame: From baseline to month 3 and month 6
Changes in physical performance
Time frame: From baseline to month 3 and month 6
Changes in fitness assessment
Time frame: From baseline to month 3 and month 6
Changes in flexibility test
Time frame: From baseline to month 3 and month 6
Changes in resting energy expenditure
Time frame: From baseline to month 3 and month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- CHANGE Alberta websiteLink provided by the sponsor.
- My Viva Plan websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doug Klein, MD principal investigator
University of Alberta
Liam Collins, MS study director
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Metabolic Rehabilitation in people with Metabolic Syndrome and Chronic Obstructive Pulmonary Disease, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Syndrome (time frame: Change From baseline to month 3 and month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.