Clinical trial NCT05422924: A Web-based Platform to Improve Physical Function, Nutrition, and Mindfulness in Patients With Long COVID
Official title: A Pilot and Feasibility Study of a Web-based Platform to Improve Physical Function, Nutrition, and Mindfulness in Patients With Long COVID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Keywords: Nutrition
Physical activity
Feasibility
Body composition
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Revive Wellness Inc.
First posted: 2022-06-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with COVID-19 may experience prolonged physical and psychological symptoms after weeks or months of the infection. This may be caused by a combination of factors including poor nutrition, low physical activity, and lack of emotional support. Leading to poor overall health and low quality of life. This evidence indicated that people with long COVID-19 need a personalized intervention. Our objective is to determine if the use of an online application that is based on preventive self-care and that includes nutrition and mindfulness will be feasible to use for patients with long COVID.

Detailed description: A Canadian web-based platform called My Viva Plan® became available. This web-based platform is based on preventive self-care and it includes three key pillars of health: nutrition and mindfulness.

Long COVID patients will be randomized into the following two groups; intervention arm (will use a web-based platform for 8 weeks) vs. control arm (will not use a web-based platform for 8 weeks).The primary aim of this study is to investigate the feasibility (defined by recruitment, adherence, and retention) of an 8-week digital nutrition and mindfulness self-care intervention program using My Viva Plan® versus usual care (i.e. general advice) in patients with long COVID who continue to have signs and symptoms not explainable by other causes. Dietary intake, physical function, body composition and mental health variables will also be explored.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years.
* COVID diagnosed (PCR positivity) \>12 weeks at time of screening and have persistent symptoms.
* Body mass index (BMI) \>18.5kg/m2 and \< 35 kg/m2.
* People with long COVID syndrome diagnosis enrolled in the Kaye Edmonton Clinic.
* Have mild to moderate long COVID syndrome (Based on the Post COVID-19 Functional Status Scale from 0-3).

Exclusion Criteria:

* Patients with severe mobility impairment (People without sufficiently mobile to come to the study centre).
* Diagnosis of severe mental health disorders (e.g., depression, anxiety, eating disorders).
* Individuals with pacemakers or other internal electrical medical devices.
* Suffer from claustrophobia.
* Pregnancy or lactation.
* No internet access.
* Not able to understand and communicate in English.
* Major visual or hearing impairment or other serious illness that would preclude participation.
* Living in assisted living situations or a nursing home.
* Individuals who fell more than 3 times in the last month. Because of the risk of doing a physical activity unsupervised.
* Not willing to make a change in their lifestyle (Readiness to change).

Primary outcomes:
measure: Feasibility (defined by recruitment, adherence, and retention).
timeFrame: Baseline, week 8
Secondary outcomes:
measure: Changes in quality of life parameters
timeFrame: Baseline, week 8
measure: Changes in fat mass
timeFrame: Baseline, week 8
measure: Changes in lean mass
timeFrame: Baseline, week 8
measure: Changes in muscle cross sectional area
timeFrame: Baseline, week 8
measure: Changes in dietary intake
timeFrame: Baseline, week 8
measure: Changes in mindfulness with Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID
timeFrame: Baseline, week 8
measure: Changes in self-efficacy assessed with Patient-Reported Outcomes Measurement Information System
timeFrame: Baseline, week 8
measure: Changes in physical function
timeFrame: Baseline, week 8
measure: Changes in physical performance
timeFrame: Baseline, week 8
measure: Changes in physical activity (daily activities subscale) by the Symptom Burden Questionnaire for Long COVID.
timeFrame: Baseline, week 8
measure: Changes in physical activity using the International Physical Activity Questionnaire
timeFrame: Baseline, week 8
measure: Changes in resting energy expenditure
timeFrame: Baseline, week 8
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Carla Prado, PhD
role: PRINCIPAL_INVESTIGATOR
References: