NCT05422924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

June 16, 2022

Last Update Submit

March 5, 2025

Conditions

Long COVID

Keywords

NutritionPhysical activityFeasibilityBody composition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Changes in quality of life parameters

    Baseline, week 8

  • Changes in fat mass

    Baseline, week 8

  • Changes in lean mass

    Baseline, week 8

  • Changes in muscle cross sectional area

    Baseline, week 8

  • Changes in dietary intake

    Baseline, week 8

  • +7 more secondary outcomes

Study Arms (2)

Control Arm

NO INTERVENTION

No use of My Viva Plan

Intervention Arm

EXPERIMENTAL

Use of My Viva Plan

Behavioral: Web-based platform. (My Viva Plan)

Interventions

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.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeMotor Activity

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Carla Prado, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 21, 2022

Study Start

August 25, 2023

Primary Completion

October 31, 2023

Study Completion

January 31, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)