Digital Metabolic Rehabilitation COPD
- Conditions
- Chronic Obstructive Pulmonary DiseaseMetabolic Syndrome
- Interventions
- Behavioral: Digital Metabolic Rehabilitation
- Registration Number
- NCT05806294
- Lead Sponsor
- University of Alberta
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-arm pilot trial Digital Metabolic Rehabilitation 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.
- Primary Outcome Measures
Name Time Method Metabolic Syndrome 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 Change From baseline to month 3 and month 6 Proportion of patients achieving reduction in waist circumference.
Blood pressure 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 Outcome Measures
Name Time Method Changes in muscle echogenicity From baseline to month 3 and month 6 Changes in muscle echogenicity by ultrasound
Changes in phase angle From baseline to month 3 and month 6 Changes in phase angle is assessed by bioelectrical impedance analysis
Changes in fat mass From baseline to month 3 and month 6 Changes in fat mass (kg) by bioelectrical impedance analysis
Changes in body weight 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)
Changes in and body mass index (BMI) 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)
Changes in fat-free mass From baseline to month 3 and month 6 Changes in fat-free mass (kg) by bioelectrical impedance analysis
Changes in muscle cross sectional area From baseline to month 3 and month 6 Changes in muscle cross sectional area (cm2) by ultrasound
Changes in flexibility test 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.
Changes in muscle strength From baseline to month 3 and month 6 Changes in muscle strength assessed by handgrip strength
Changes in physical performance From baseline to month 3 and month 6 Changes in physical performance assessed by 6-minute walk test
Changes in resting energy expenditure From baseline to month 3 and month 6 Changes in resting energy expenditure assessed by indirect calorimetry
Changes in fitness assessment 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.
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada