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OpenTrials
Completed

NCT Number: NCT05806294

Digital Metabolic Rehabilitation COPD

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. Waist circumference

    Time frame: Change From baseline to month 3 and month 6

    Proportion of patients achieving reduction in waist circumference.

  3. 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.

Secondary outcomes

  1. Changes in body weight

    Time frame: From baseline to month 3 and month 6

    Changes in body weight will be measured using calibrated digital scale (Health o meter® Professional Remote Display, Sunbeam Products Inc., Fla., USA)

  2. Changes in and body mass index (BMI)

    Time frame: From baseline to month 3 and month 6

    The intervention's ability to promote changes in BMI (weight and height will be combined to report BMI in kg/m^2)

  3. Changes in fat mass

    Time frame: From baseline to month 3 and month 6

    Changes in fat mass (kg) by bioelectrical impedance analysis

  4. Changes in phase angle

    Time frame: From baseline to month 3 and month 6

    Changes in phase angle is assessed by bioelectrical impedance analysis

  5. Changes in fat-free mass

    Time frame: From baseline to month 3 and month 6

    Changes in fat-free mass (kg) by bioelectrical impedance analysis

  6. Changes in muscle cross sectional area

    Time frame: From baseline to month 3 and month 6

    Changes in muscle cross sectional area (cm2) by ultrasound

  7. Changes in muscle echogenicity

    Time frame: From baseline to month 3 and month 6

    Changes in muscle echogenicity by ultrasound

  8. Changes in muscle strength

    Time frame: From baseline to month 3 and month 6

    Changes in muscle strength assessed by handgrip strength

  9. Changes in physical performance

    Time frame: From baseline to month 3 and month 6

    Changes in physical performance assessed by 6-minute walk test

  10. Changes in fitness assessment

    Time frame: From baseline to month 3 and month 6

    Changes in fitness test are assessed using the maximum number of partial curl-ups (up to 25) and push-ups performed in one minute.

  11. Changes in flexibility test

    Time frame: From baseline to month 3 and month 6

    Changes in trunk flexion range of motion will be evaluated using inertial measuring units during bending in standing position.

  12. Changes in resting energy expenditure

    Time frame: From baseline to month 3 and month 6

    Changes in resting energy expenditure assessed by indirect calorimetry

Other outcomes

  1. Changes in quality of life parameters

    Time frame: From baseline to month 3 and month 6

    Changes in scores of quality of life are assessed by the Chronic Respiratory Questionnaire (CRQ). The Items are scaled in Numerical, 7-point modified Likert Scale. Higher scores indicate a better health-related quality of life

  2. Changes in SF-12 score

    Time frame: From baseline to month 3 and month 6

    Changes in physical and mental well-being are assessed in 8 domains (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health) by the Short Form 12 (SF-12).

  3. Changes in cardiovascular disease risk

    Time frame: From baseline to month 3 and month 6

    Changes in cardiovascular disease risk by Prospective Cardiovascular Munster scores (PROCAM). PROCAM predicts cardiovascular risk in 10 years (<1% to > 40%). The higher the scores, the greater the cardiovascular risk

  4. Well being changes

    Time frame: From baseline to month 3 and month 6

    Changes in well-being are assessed by the World Health Organization Well-Being Index (WHO-5). The raw scores are transformed to a score from 0 to 100, with lower scores indicating worse well-being

  5. Mental health

    Time frame: From baseline to month 3 and month 6

    Mental health and depression are assessed by the Patient Health Questionnaire - 9 (PHQ-9). PHQ-9 score will be obtained by adding the score for each question (total points). Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively

  6. Changes in psychosocial determinants of behavioral

    Time frame: From baseline to month 3 and month 6

    Physical Activity Readiness Questionnaire (PAR-Q+) will be used to assess the readiness of participants to engage in physical activity and determines any safety and possible risks that could be impacted by physical activity

  7. Changes in hospital admissions rates for exacerbation of COPD

    Time frame: From baseline to month 6

    Exacerbation of COPD events is measured by outpatient visits, emergency room visits, and hospitalizations

  8. Changes in hospital admissions rates for myocardial infarction events

    Time frame: From baseline to month 3 and month 6

    Myocardial infarction events are measured by outpatient visits, emergency room visits, and hospitalizations

  9. Changes in hospital admissions rates for ischemic stroke events

    Time frame: From baseline to month 3 and month 6

    Ischemic stroke events are measured by outpatient visits, emergency room visits, and hospitalizations

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Revive Wellness Inc.

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 10, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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