A Web-based Platform to Improve Physical Function, Nutrition, and Mindfulness in Patients With Long COVID

Long COVID Clinical Trial

— BLEND  

Official title:

A Pilot and Feasibility Study of a Web-based Platform to Improve Physical Function, Nutrition, and Mindfulness in Patients With Long COVID

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05422924
• Other study ID #: Pro00120894
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Alberta
• Contact: Montserrat Montes de Oca, MSc
• Phone: 780-492-7820
• Email: mmontesd[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Long COVID

Intervention

Behavioral:
• Web-based platform. (My Viva Plan)
Participants will use a web-based platform (i.e. My Viva Plan®) to improve physical function, nutrition and mindfulness.

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
Primary	Feasibility (defined by recruitment, adherence, and retention).	The proportion of participants that agreed to participate, the engagement in the platform (login), participants who complete both visits	Baseline, week 8
Secondary	Changes in quality of life parameters	Changes in scores of quality of life assessed by EuroQol 5-level EQ-5D.	Baseline, week 8
Secondary	Changes in fat mass	Changes in fat mass (kg) using bioelectrical impedance analysis	Baseline, week 8
Secondary	Changes in lean mass	Changes in lean mass (kg) using bioelectrical impedance analysis	Baseline, week 8
Secondary	Changes in muscle cross sectional area	Changes in muscle cross sectional area (cm2) using an ultrasound	Baseline, week 8
Secondary	Changes in dietary intake	Changes in diet quality assessed by dietary intake assessed by Automated Self-Administered 24-hour dietary assessment tool and analysed with Canadian version of the Healthy Eating Index	Baseline, week 8
Secondary	Changes in mindfulness with Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID	Changes in mindfulness assessed by Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID (SBQ-LC). 9-item measure. Scores are to 0-100 linear. Higher scores indicate greater symptom burden.	Baseline, week 8
Secondary	Changes in self-efficacy assessed with Patient-Reported Outcomes Measurement Information System	Changes in self-efficacy for managing chronic conditions with of 8-item questionnaire that is based on a Patient-Reported Outcomes Measurement Information System (PROMIS).The total raw score (ranging from 8 to 40) will be transferred to a T-score. A mean of 50 and a standard deviation (SD) of 10 will be the average. A higher PROMIS T-score indicates that the respondent has greater self-efficacy for managing their emotions than the general chronic condition population.	Baseline, week 8
Secondary	Changes in physical function	Changes in physical function assessed by handgrip strength	Baseline, week 8
Secondary	Changes in physical performance	Changes in physical performance assessed by 6-minute walk test	Baseline, week 8
Secondary	Changes in physical activity (daily activities subscale) by the Symptom Burden Questionnaire for Long COVID.	Changes in physical activity assessed by Daily Activities Symptom Burden Questionnaire for Long COVID (SBQ-LC). Raw scores (ranging from 0 to 24) will be converted to 0-100 linear scores with conversion tables. Higher scores indicate greater symptom burden.	Baseline, week 8
Secondary	Changes in physical activity using the International Physical Activity Questionnaire	Changes in physical activity assessed by International Physical Activity Questionnaire (IPAQ). This questionnaire collects information about three specific types of physical activity: walking, moderate-intensity activities and vigorous intensity activities. To compute the total score, measures of frequency (measured in days per week) and duration (time per day) are needed. We will use this information to compare over time.	Baseline, week 8
Secondary	Changes in resting energy expenditure	Changes in resting energy expenditure assessed by a metabolic cart (indirect calorimetry)	Baseline, week 8