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Physical Activity Post COVID-19 (PA-COVID19)

U

University of Alcala

Status

Completed

Conditions

Covid19

Treatments

Behavioral: Physical activity

Study type

Observational

Funder types

Other

Identifiers

NCT04768257
CEID/HU/2020/51

Details and patient eligibility

About

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.

Full 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.

Enrollment

148 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

148 participants in 5 patient groups

Patients with COVID-19, treated in intensive care
Treatment:
Behavioral: Physical activity
Patients with COVID-19, treated in hospital ward
Treatment:
Behavioral: Physical activity
Patients with COVID-19, treated at home
Treatment:
Behavioral: Physical activity
People with Long COVID (secondary analysis)
Description:
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.
People without Long COVID (secondary analysis)
Description:
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

Trial contacts and locations

1

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Central trial contact

María José Yuste Sánchez, PT, PhD; Nicola Sante Diciolla, PT, MSc

Data sourced from clinicaltrials.gov

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