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OpenTrials
Completed

NCT Number: NCT05422924

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

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.

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Key information

Conditions

Long COVID Behavior COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Motor Activity Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Web-based platform. (My Viva Plan)

Behavioral

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

Primary outcomes

  1. Feasibility (defined by recruitment, adherence, and retention).

    Time frame: Baseline, week 8

    The proportion of participants that agreed to participate, the engagement in the platform (login), participants who complete both visits

Secondary outcomes

  1. Changes in quality of life parameters

    Time frame: Baseline, week 8

    Changes in scores of quality of life assessed by EuroQol 5-level EQ-5D.

  2. Changes in fat mass

    Time frame: Baseline, week 8

    Changes in fat mass (kg) using bioelectrical impedance analysis

  3. Changes in lean mass

    Time frame: Baseline, week 8

    Changes in lean mass (kg) using bioelectrical impedance analysis

  4. Changes in muscle cross sectional area

    Time frame: Baseline, week 8

    Changes in muscle cross sectional area (cm2) using an ultrasound

  5. Changes in dietary intake

    Time frame: Baseline, week 8

    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

  6. Changes in mindfulness with Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID

    Time frame: Baseline, week 8

    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.

  7. Changes in self-efficacy assessed with Patient-Reported Outcomes Measurement Information System

    Time frame: Baseline, week 8

    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.

  8. Changes in physical function

    Time frame: Baseline, week 8

    Changes in physical function assessed by handgrip strength

  9. Changes in physical performance

    Time frame: Baseline, week 8

    Changes in physical performance assessed by 6-minute walk test

  10. Changes in physical activity (daily activities subscale) by the Symptom Burden Questionnaire for Long COVID.

    Time frame: Baseline, week 8

    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.

  11. Changes in physical activity using the International Physical Activity Questionnaire

    Time frame: Baseline, week 8

    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.

  12. Changes in resting energy expenditure

    Time frame: Baseline, week 8

    Changes in resting energy expenditure assessed by a metabolic cart (indirect calorimetry)

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Revive Wellness Inc.

Registry information

Official study title

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

Acronym: BLEND

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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