Digital Metabolic Rehabilitation COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806294
• Other study ID #: Pro00116810
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: University of Alberta
• Contact: Bruna Ramos da Silva, PhD
• Phone: 780-492-7820
• Email: ramosdas[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Metabolic Syndrome
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Digital Metabolic Rehabilitation
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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Revive Wellness Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in quality of life parameters	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	From baseline to month 3 and month 6
Other	Changes in SF-12 score	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).	From baseline to month 3 and month 6
Other	Changes in cardiovascular disease risk	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	From baseline to month 3 and month 6
Other	Well being changes	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	From baseline to month 3 and month 6
Other	Mental health	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	From baseline to month 3 and month 6
Other	Changes in psychosocial determinants of behavioral	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	From baseline to month 3 and month 6
Other	Changes in hospital admissions rates for exacerbation of COPD	Exacerbation of COPD events is measured by outpatient visits, emergency room visits, and hospitalizations	From baseline to month 6
Other	Changes in hospital admissions rates for myocardial infarction events	Myocardial infarction events are measured by outpatient visits, emergency room visits, and hospitalizations	From baseline to month 3 and month 6
Other	Changes in hospital admissions rates for ischemic stroke events	Ischemic stroke events are measured by outpatient visits, emergency room visits, and hospitalizations	From baseline to month 3 and month 6
Primary	Metabolic Syndrome	Proportion of patients achieving reversal of Metabolic Syndrome (no longer meeting 3 of 5 diagnostic criteria)	Change From baseline to month 3 and month 6
Primary	Waist circumference	Proportion of patients achieving reduction in waist circumference.	Change From baseline to month 3 and month 6
Primary	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.	Change From baseline to month 3 and month 6
Secondary	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)	From baseline to month 3 and month 6
Secondary	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)	From baseline to month 3 and month 6
Secondary	Changes in fat mass	Changes in fat mass (kg) by bioelectrical impedance analysis	From baseline to month 3 and month 6
Secondary	Changes in phase angle	Changes in phase angle is assessed by bioelectrical impedance analysis	From baseline to month 3 and month 6
Secondary	Changes in fat-free mass	Changes in fat-free mass (kg) by bioelectrical impedance analysis	From baseline to month 3 and month 6
Secondary	Changes in muscle cross sectional area	Changes in muscle cross sectional area (cm2) by ultrasound	From baseline to month 3 and month 6
Secondary	Changes in muscle echogenicity	Changes in muscle echogenicity by ultrasound	From baseline to month 3 and month 6
Secondary	Changes in muscle strength	Changes in muscle strength assessed by handgrip strength	From baseline to month 3 and month 6
Secondary	Changes in physical performance	Changes in physical performance assessed by 6-minute walk test	From baseline to month 3 and month 6
Secondary	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.	From baseline to month 3 and month 6
Secondary	Changes in flexibility test	Changes in trunk flexion range of motion will be evaluated using inertial measuring units during bending in standing position.	From baseline to month 3 and month 6
Secondary	Changes in resting energy expenditure	Changes in resting energy expenditure assessed by indirect calorimetry	From baseline to month 3 and month 6

External Links

•   CHANGE Alberta website
•   My Viva Plan website