Clinical trial NCT04768257: Physical Activity Post COVID-19
Official title: Physical Activity Post Coronavirus (COVID-19). a Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid19
Physical activity
Exercise capacity
Functional capacity
Long COVID
Lead sponsor: University of Alcala
Sponsor class: OTHER
Collaborators: name: Professional College of Physiotherapists of the Community of Madrid (CPFCM)
name: University Hospital of Guadalajara (HUGU)
First posted: 2021-02-24
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Three cohorts of patients affected from SARS-CoV-2; 1-treated in intensive care; 2-treated in hospital ward and 3-treated at home. Groups will be age and gender matched.

People with and without Long COVID (secondary analysis)

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.

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.

Primary outcomes:
measure: Change in Physical activity (PA) patterns (steps/day) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in Physical activity (PA) patterns (time spent in moderate-to-vigorous PA) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in Physical activity (PA) patterns (time spent in moderate-to-vigorous PA, in bouts of 10 minutes) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in Physical activity (PA) patterns (Mean duration of bouts of moderate-to-vigorous PA) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in Physical activity (PA) patterns (total time in sedentary behaviour -lying or sitting-) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in Physical activity (PA) patterns (mean duration of a sedentary bout) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in functional capacity (six-minutes walking test) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in functional capacity (one-minute sit-to-stand test) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
Secondary outcomes:
measure: Change in isometric quadriceps strength from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in handgrip force from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in maximal inspiratory and expiratory pressures from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in health-related quality of life from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in dyspnea symptom from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in fatigue symptom from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Change in anxiety and depression symptoms from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Forced expiratory volume in the first second (FEV1) assessed using spirometry at baseline (at hospital discharge or patient's home)
timeFrame: Baseline
measure: Forced vital capacity (FVC) assessed using spirometry at baseline (at hospital discharge or patient's home)
timeFrame: Baseline
measure: Ratio between Forced expiratory volume in the first second and Forced vital capacity (FEV1/FVC) assessed using spirometry at baseline (at hospital discharge or patient's home)
timeFrame: Baseline
measure: Sociodemographics (age) at baseline (at hospital discharge or patient's home)
timeFrame: Baseline
measure: Sociodemographics (sex) at baseline (at hospital discharge or patient's home)
timeFrame: Baseline
measure: Anthropometrics (height) at baseline (at hospital discharge or patient's home)
timeFrame: Baseline
measure: Change in anthropometrics (weight) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks and 6 months
measure: Relevant clinical history (diagnosis with lung or cardiovascular disease) at baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Guadalajara
country: Spain
facility: University Hospital of Guadalajara
state: Castilla La Mancha
Study officials:
affiliation: University of Alcalá
name: Nicola Sante Diciolla, PT, MSc
role: PRINCIPAL_INVESTIGATOR
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