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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05806294
Other study ID # Pro00116810
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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