NCT05228691

Brief Summary

With more than 246 million people diagnosed with coronavirus 2019 (COVID-19) around the world, many of whom have required medical attention for past 23 months, greater emphasis is being placed on post-acute care of COVID-19 survivors. According to recent data, millions of patients who have recovered from acute COVID-19 are experiencing persistent symptoms, which lead to disability and impaired activities of daily living. Various terms have been used to describe the condition of patients who do not return to their initial health status to include post-acute sequelae of COVID-19, such as post-acute COVID syndrome (PACS) and Long COVID. The growing global burden of COVID-19 suggests that the potential effects of Long COVID in public health are vast even if Long COVID is experienced by a small proportion of patients recovering from acute infection. The ability to identify patients at high risk for Long COVID and forecasting medical resource requirements is of important clinical utility in the present. In view of the large number of people surviving after infection with COVID-19 and that should require follow-up, determine which patients are at risk of have Long COVID and who require close monitoring is crucial. In this study, therefore, we set out to analyze what type of patient profile with COVID-19 who, after 12 weeks of having suffered the infection, experiences the signs and symptoms described by current literature.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

3.8 years

First QC Date

February 5, 2022

Last Update Submit

August 21, 2025

Conditions

Keywords

physical therapy modalityLong COVIDpost-acute COVID-19 syndrome

Outcome Measures

Primary Outcomes (4)

  • Post-COVID-19 Functional Status scale

    The scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death, D), and covers the full range of functional outcomes by focusing on limitations in usual tasks/activities, whether at home or at work/study, as well as lifestyle changes. The scale ratings are intuitive and can be easily understood by clinicians and patients alike.

    5 days before start the intervention

  • Short Physical Performance Battery

    The Short Physical Performance Battery (SPPB) is a measure of physical performance that has been used to predict long-term disability and/or future institutionalization in adults aged 65 years and older. The test consists of three specific physical performance activities, scored from 0 to 4, with a summed score of 12. Higher scores reflect higher levels of function.

    Baseline at 0 minutes

  • Aerobic capacity

    Aerobic capacity will be measured with the 1 minute sit to stand test: The purpose of the test is to assess the exercise capacity and leg muscle strength. The movement required is to get up from this chair with the legs straight and sit back continuing the repetitions as fast as possible within one minute. The mean number of 1-minute sit to stand test repetitions reported in the literature achieved ranged from 8.1 (patients with stroke) to 50.0 (young men).

    Baseline at 0 minutes

  • Muscle Strength

    Muscle Strength will be measured with Medical Research Council (MRC) Scale : is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). This score was defined as the sum of the MRC scores of six muscles in the upper and lower limbs on both sides, so the score ranged from 60 (normal) to 0 (quadriplegic). The Criteria require that each of the six muscle groups be tested bilaterally, each scoring from 0 to 5.

    Baseline at 0 minutes

Secondary Outcomes (5)

  • Musculoskeletal pain

    5 days before start the intervention

  • Dyspnea

    5 days before start the intervention

  • Fatigue

    5 days before start the intervention

  • Physical activity

    5 days before start the intervention

  • Subjective health status assessment

    5 days before start the intervention

Study Arms (1)

Long COVID

Participants will self-complete some questionnaires, while the rest of the variables will be evaluated by the evaluating physiotherapist. After the consultation, the evaluator himself will provide the participants with some recommendations that he should make. As support, a diptych has been made with different general activities to be developed by the participant. With the purpose of track this activity, they will be informed that they will be contacted once 6 months have passed since the evaluation (via phone call or SMS).

Other: Evaluation and Education

Interventions

A functional physical evaluation will be carried out and they will be informed about the characteristics of their symptoms. After the evaluation, they will be taught a guideline of exercises and recommendations.

Long COVID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from the Autonomous Community of the Canary Islands presenting signs and symptoms related to COVID-19 and that last beyond 12 weeks from when disease debuted.

You may qualify if:

  • Have been positive for COVID-19 since the declaration of the state of alarm throughout the Spanish territory to deal with the health emergency situation caused by COVID-19 (March 14, 2020).
  • Symptoms associated with COVID-19 at least after 12 weeks of its detection.
  • Adequate cognitive and physical level to understand and perform the tests evaluation.

You may not qualify if:

  • Present comorbidities prior to suffering from COVID-19 whose symptoms are resemble Post-acute COVID-19.
  • Fibromyalgia.
  • Chronic fatigue.
  • Neuromuscular disease.
  • Not having signed the informed consent.
  • Person undergoing treatment for active cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Las Palmas de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

RECRUITING

Related Publications (4)

  • Carvalho-Schneider C, Laurent E, Lemaignen A, Beaufils E, Bourbao-Tournois C, Laribi S, Flament T, Ferreira-Maldent N, Bruyere F, Stefic K, Gaudy-Graffin C, Grammatico-Guillon L, Bernard L. Follow-up of adults with noncritical COVID-19 two months after symptom onset. Clin Microbiol Infect. 2021 Feb;27(2):258-263. doi: 10.1016/j.cmi.2020.09.052. Epub 2020 Oct 5.

  • Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re'em Y, Redfield S, Austin JP, Akrami A. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021 Aug;38:101019. doi: 10.1016/j.eclinm.2021.101019. Epub 2021 Jul 15.

  • Goertz YMJ, Van Herck M, Delbressine JM, Vaes AW, Meys R, Machado FVC, Houben-Wilke S, Burtin C, Posthuma R, Franssen FME, van Loon N, Hajian B, Spies Y, Vijlbrief H, van 't Hul AJ, Janssen DJA, Spruit MA. Persistent symptoms 3 months after a SARS-CoV-2 infection: the post-COVID-19 syndrome? ERJ Open Res. 2020 Oct 26;6(4):00542-2020. doi: 10.1183/23120541.00542-2020. eCollection 2020 Oct.

  • Iqbal FM, Lam K, Sounderajah V, Clarke JM, Ashrafian H, Darzi A. Characteristics and predictors of acute and chronic post-COVID syndrome: A systematic review and meta-analysis. EClinicalMedicine. 2021 May 24;36:100899. doi: 10.1016/j.eclinm.2021.100899. eCollection 2021 Jun.

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 Syndrome

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Aníbal Báez Suárez, PhD

    University of Las Palmas de Gran Canaria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aníbal Báez Suárez, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2022

First Posted

February 8, 2022

Study Start

March 22, 2022

Primary Completion

December 22, 2025

Study Completion

May 1, 2026

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations