Physical Activity Post Coronavirus (COVID-19). a Longitudinal Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- University of Alcala
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Nicola Sante Diciolla
Associate Researcher, PhD Student
University of Alcala
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.
Outcomes
Primary Outcomes
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
Time Frame: Baseline, 12 weeks and 6 months
Patients will wear a tri-axial accelerometer for 1 week. A valid assessment will be a minimum of two days with at least 8 hours of wearing time, weekends excluded. The minute-by-minute output of the number of steps and metabolic equivalents of task (METs) will be exported. Using a statistical package, we will be calculate: Mean duration of bouts of moderate-to-vigorous PA (MVPA, hours and minutes).
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
Time Frame: Baseline, 12 weeks and 6 months
One-minute sit-to-stand \[1minSTS\]. Patients will sit and stand from a chair, without the aid of the upper limbs, many times as they can in a 1-min bout. Afterwards, the results will be compared to age- and sex-matched reference values.
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
Time Frame: Baseline, 12 weeks and 6 months
Patients will wear a tri-axial accelerometer for 1 week. A valid assessment will be a minimum of two days with at least 8 hours of wearing time, weekends excluded. The minute-by-minute output of the number of steps and metabolic equivalents of task (METs) will be exported. Using a statistical package, we will be calculate: Total time in sedentary behaviour (lying and/or sitting, hours and minutes).
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
Time Frame: Baseline, 12 weeks and 6 months
Patients will wear a tri-axial accelerometer for 1 week. A valid assessment will be a minimum of two days with at least 8 hours of wearing time, weekends excluded. The minute-by-minute output of the number of steps and metabolic equivalents of task (METs) will be exported. Using a statistical package, we will be calculate: Mean duration of a sedentary bout (hours and minutes).
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
Time Frame: Baseline, 12 weeks and 6 months
Patients will wear a tri-axial accelerometer for 1 week. A valid assessment will be a minimum of two days with at least 8 hours of wearing time, weekends excluded. The minute-by-minute output of the number of steps and metabolic equivalents of task (METs) will be exported. Using a statistical package, we will be calculate: Total time spent in moderate-to-vigorous PA (MVPA, hours and minutes).
Change in functional capacity (six-minutes walking test) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
Time Frame: Baseline, 12 weeks and 6 months
Six-minutes walking test/distance \[6MWT/6MWD\]. Patients will be asked to walk as far as possible in 6 min along a flat 30m corridor. Standardised instructions and encouragement will be given during the test, following European Respiratory Society/American Thoracic Society statement.
Change in Physical activity (PA) patterns (steps/day) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
Time Frame: Baseline, 12 weeks and 6 months
Patients will wear a tri-axial accelerometer for 1 week. A valid assessment will be a minimum of two days with at least 8 hours of wearing time, weekends excluded. The minute-by-minute output of the number of steps and metabolic equivalents of task (METs) will be exported. Using a statistical package, we will be calculate: Total daily step count (steps/day).
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
Time Frame: Baseline, 12 weeks and 6 months
Patients will wear a tri-axial accelerometer for 1 week. A valid assessment will be a minimum of two days with at least 8 hours of wearing time, weekends excluded. The minute-by-minute output of the number of steps and metabolic equivalents of task (METs) will be exported. Using a statistical package, we will be calculate: Time spent in moderate-to-vigorous PA (MVPA), performed in bouts of at least 10 minutes (hours and minutes).
Secondary Outcomes
- Forced vital capacity (FVC) assessed using spirometry at baseline (at hospital discharge or patient's home)(Baseline)
- Change in health-related quality of life from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months(Baseline, 12 weeks and 6 months)
- Change in dyspnea symptom from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months(Baseline, 12 weeks and 6 months)
- Sociodemographics (sex) at baseline (at hospital discharge or patient's home)(Baseline)
- Change in isometric quadriceps strength from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months(Baseline, 12 weeks and 6 months)
- Change in handgrip force from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months(Baseline, 12 weeks and 6 months)
- Change in maximal inspiratory and expiratory pressures from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months(Baseline, 12 weeks and 6 months)
- Change in fatigue symptom from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months(Baseline, 12 weeks and 6 months)
- Forced expiratory volume in the first second (FEV1) assessed using spirometry at baseline (at hospital discharge or patient's home)(Baseline)
- Sociodemographics (age) at baseline (at hospital discharge or patient's home)(Baseline)
- Anthropometrics (height) at baseline (at hospital discharge or patient's home)(Baseline)
- Relevant clinical history (diagnosis with lung or cardiovascular disease) at baseline(Baseline)
- Change in anxiety and depression symptoms from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months(Baseline, 12 weeks and 6 months)
- 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)(Baseline)
- Change in anthropometrics (weight) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months(Baseline, 12 weeks and 6 months)