Physical Activity Post COVID-19

NCT ID: NCT04768257

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-12-01

Brief Summary

THis study aims to examine PA trajectory, and potential behaviour-change factors least 12 months after COVID-19, across different levels of acute disease severity, and specifically in people with and without Long COVID.

Detailed Description

Eligible participants will be contacted and invited for a first visit by a pulmonologist or a respiratory physiotherapist, during which those interested will provide informed consent. Participants will be interviewed and medical records reviewed to collect sociodemographic, anthropometric, and clinical data. Then, functional capacity, peripheral muscle strength, and lung function will be assessed using several tests, and dyspnoea, fatigue, anxiety, depression, and HRQoL through self-administrated questionnaires. Finally, people will be provided with a specific device and instructed on its use for measuring daily PA over one week. A pulmonologist, specialized nurse, or technician from the corresponding centre will perform and assess spirometry, while two respiratory physiotherapists will conduct and supervise all other tests in a reserved space at the same centre. The assessments were scheduled at three time points: at least 12 months after hospital/medical discharge (baseline), three and six months afterward.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with COVID-19, treated in intensive care

Physical activity

Intervention Type: BEHAVIORAL

We will assess physical activity patterns of patients at baseline (at discharge from hospital or at patients' home), at 12 weeks and 6 months, through an objective measurement (triaxial accelerometer).

Patients with COVID-19, treated in hospital ward

Physical activity

Intervention Type: BEHAVIORAL

We will assess physical activity patterns of patients at baseline (at discharge from hospital or at patients' home), at 12 weeks and 6 months, through an objective measurement (triaxial accelerometer).

Patients with COVID-19, treated at home

Physical activity

Intervention Type: BEHAVIORAL

We will assess physical activity patterns of patients at baseline (at discharge from hospital or at patients' home), at 12 weeks and 6 months, through an objective measurement (triaxial accelerometer).

People with Long COVID (secondary analysis)

People from any of the three cohorts of patients with COVID-19 reporting clinically relevant symptoms among dyspnoea, fatigue, anxiety, depression or impaired health-related quality of life will be considered affected from post-COVID-19 condition or Long COVID.

No interventions assigned to this group

People without Long COVID (secondary analysis)

People from any of the three cohorts of patients with COVID-19 not reporting clinically relevant symptoms among dyspnoea, fatigue, anxiety, depression or impaired health-related quality of life will be considered affected from post-COVID-19 condition or Long COVID

No interventions assigned to this group

Interventions

Physical activity

We will assess physical activity patterns of patients at baseline (at discharge from hospital or at patients' home), at 12 weeks and 6 months, through an objective measurement (triaxial accelerometer).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• At least, 18 years of age;
• Diagnosis with COVID-19;
• Stable condition at hospital discharge or after 21 days of being treated at home (needed time to recover from an acute respiratory infection; however, patients treated at home should report a negative result in polymerase chain reaction [PCR] test).

Those reporting clinically relevant symptoms among dyspnoea, fatigue, anxiety, depression or impaired health-related quality of life will be considered affected from post-COVID-19 condition or Long COVID.

Exclusion Criteria

• Presence of signs of cognitive impairment or significant cardiovascular, neurological, and/or musculoskeletal disease, which may prevent the assessment tests and therefore limit participation. In particular, reasons for exclusion will be the following: cognitive disorders, such as sequelae of Alzheimer's disease, senile dementia; comprehension disorders, such as Wernicke's aphasia; cognitive-motor disorders, such as hemiparesis/hemiplegia due to stroke; musculoskeletal disorders, such as unconsolidated fractures, external prostheses (including replacements in amputees); cardiovascular disorders, such as unstable angina, recent acute myocardial infarction, among others.
• Vacination before infection.
• Reinfections during follow-up.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Professional College of Physiotherapists of the Community of Madrid (CPFCM)

UNKNOWN

Sponsor Role: collaborator

University Hospital of Guadalajara (HUGU)

UNKNOWN

Sponsor Role: collaborator

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Nicola Sante Diciolla

Associate Researcher, PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Sante Diciolla, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alcalá

Locations

University Hospital of Guadalajara

Guadalajara, Castille-La Mancha, Spain

Countries

Spain

References

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Other Identifiers

CEID/HU/2020/51

Identifier Type: -

Identifier Source: org_study_id