Covid19PA-COVID19NCT04768257
Physical Activity Post COVID-19
An observational study of Covid19, run by University of Alcala at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
University Hospital of Guadalajara
Guadalajara, Castille-La Mancha, 19002
About this study
Official title: Physical Activity Post Coronavirus (COVID-19). a Longitudinal Study
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.
Read the 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
- Being tested
- Physical activity
- Keywords
- Covid19, Physical activity, Exercise capacity, Functional capacity, Long COVID
- Medical subject headings
- COVID-19, Motor Activity, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID-19, treated in intensive care | Not described Receives: Behavioral: Physical activity | |
| Patients with COVID-19, treated in hospital ward | Not described Receives: Behavioral: Physical activity | |
| Patients with COVID-19, treated at home | Not described Receives: Behavioral: Physical activity | |
| 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. | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical activity (PA) patterns (steps/day) from baseline (at hospital discharge or patient's home) at 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).
Measured: Baseline, 12 weeks and 6 months
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
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).
Measured: Baseline, 12 weeks and 6 months
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
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).
Measured: Baseline, 12 weeks and 6 months
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
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).
Measured: Baseline, 12 weeks and 6 months
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
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).
Measured: Baseline, 12 weeks and 6 months
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
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).
Measured: Baseline, 12 weeks and 6 months
Change in functional capacity (six-minutes walking test) from baseline (at hospital discharge or patient's home) at 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.
Measured: Baseline, 12 weeks and 6 months
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
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.
Measured: Baseline, 12 weeks and 6 months
Secondary outcomes (15)
Change in isometric quadriceps strength from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
Isometric quadriceps strength (dynamometer). A hand-held dynamometer will be used to assess isometric strength of both legs. Participants will be seated at the edge of a treatment table, positioned near their maximal knee extension (0º), and with arms across the chest. The dynamometer will be positioned two fingers width above the lateral malleolus on the anterior aspect of the tibia.
Four warm-ups will be allowed, on each at 25, 50, 75, and 100% of perceived effort, gradually building up to a maximal effort over 1 to 2 seconds.
The tester will perform two make tests with the subject exerting 100% effort for 3 seconds. Average peak force of the two trials will be used to determine quadriceps muscle performance. The make test will entail the examiner giving appropriate resistance to the muscle force in order to ensure isometric conditions.
After allowing 1 minute of rest, the procedure will be repeated at 60º of knee flexion.
Measured: 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
Handgrip force (dynamometer). A hand-held dynamometer will be used to measure isometric strength of the grip. Participants will be seated on a straight back chair with both feet flat on the floor. Arm positioning will be demonstrated by the examiner: the tested arm will have the elbow bended to 90º, the forearm and wrist in neutral position, and the fingers flexed as needed for a maximal contraction, while the not-tested arm will assume an adducted and neutrally rotated shoulder position.
Subjects will be instructed to breathe in through their nose and blow out through pursed lips while making a maximum grip effort. At this time, a verbal encouragement will be given by the examiner (e.g., "Squeeze! Harder! Harder! Relax!"). Four minutes or more of rest will be allowed between each grip assessment. The average score among 3 trials will be recorded.
Measured: 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
Maximal respiratory pressures will be measured using a specific device; then, the highest value of 3 attempts will be selected to obtain a reliable average, excluding pressure peaks lower than one second. Participants will be asked to sit with their neck and chest in an upright position and their feet flat on the floor. The results will be read using the reference values provided by Black and Hyatt equations.
Measured: Baseline, 12 weeks and 6 months
Change in health-related quality of life from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
Health-related quality of life (EQ-5D-5L questionnaire). The EQ-5D-5L consists of two parts: the descriptive system and a visual analogue scale (VAS). The descriptive system addresses five different dimensions (mobility, self-care, usual activities. pain/discomfort, and anxiety/depression), each with a five-point Likert-scale; the answering pattern can be transferred to a utility between 0 and 1 (the higher the better) by distinct (nation-specific) scoring algorithms. On the other hand, the VAS allows valuing current health on a 0-100 mm scale, with higher values indicating better health.
Measured: 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
Dyspnea - modified Medical Research Council (mMRC) scale. The mMRC dyspnea scale consists of five grades of increasing severity. A higher score indicates a greater impact of dyspnea on activities of daily life.
Measured: 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
Fatigue - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale.
The FACIT-F scale consists of many items to produce a global score, and each item can be scored from 0 to 4 (from "not at all" to "very much"). It covers different aspects of fatigue (physical, functional, emotional, and social consequences) with regard to the previous seven days. A higher score reflects less fatigue.
Measured: Baseline, 12 weeks and 6 months
Change in anxiety and depression symptoms from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
Anxiety and depression-The Hospital Anxiety and Depression Scale (HADS). The HADS consists of two subscales (HADS-A, for anxiety disorders, and HADS-D, for depression) both containing seven intermingled items. A higher score implies a more severe case.
Measured: 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)
Forced expiratory volume in the first second (FEV1, milliliters)
Measured: Baseline
Forced vital capacity (FVC) assessed using spirometry at baseline (at hospital discharge or patient's home)
Forced vital capacity (FVC, milliliters)
Measured: Baseline
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)
Ratio between Forced expiratory volume in the first second and Forced vital capacity (FEV1/FVC, percentage)
Measured: Baseline
Sociodemographics (age) at baseline (at hospital discharge or patient's home)
Sociodemographics (age in years).
Measured: Baseline
Sociodemographics (sex) at baseline (at hospital discharge or patient's home)
Sociodemographics (sex, assessed as male/female).
Measured: Baseline
Anthropometrics (height) at baseline (at hospital discharge or patient's home)
Anthropometrics (height in meters).
Measured: Baseline
Change in anthropometrics (weight) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
Anthropometrics (weight in kilograms).
Measured: Baseline, 12 weeks and 6 months
Relevant clinical history (diagnosis with lung or cardiovascular disease) at baseline
We will report the presence of any relevant clinical history related to lung or cardiovascular disease, cardiovascular risk or immunosuppressed status (for instance, due to cancer treatment or other pathology).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 May 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Collaborators
- Professional College of Physiotherapists of the Community of Madrid (CPFCM), University of Guadalajara
- Responsible party
- Principal investigator, Nicola Sante Diciolla, University of Alcala
- Investigators
- Nicola Sante Diciolla, PT, MSc, Principal investigator, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768257
- Sponsor's protocol ID
- CEID/HU/2020/51
- Acronym
- PA-COVID19
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after drafting the final version of the database.
Publications
Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8.
PubMed 23397303Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.
PubMed 24603844Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.
PubMed 7624188Deones VL, Wiley SC, Worrell T. Assessment of quadriceps muscle performance by a hand-held dynamometer and an isokinetic dynamometer. J Orthop Sports Phys Ther. 1994 Dec;20(6):296-301. doi: 10.2519/jospt.1994.20.6.296.
PubMed 7849749Hamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9. doi: 10.2519/jospt.1992.16.5.215.
PubMed 18796752Szentes BL, Kreuter M, Bahmer T, Birring SS, Claussen M, Waelscher J, Leidl R, Schwarzkopf L. Quality of life assessment in interstitial lung diseases:a comparison of the disease-specific K-BILD with the generic EQ-5D-5L. Respir Res. 2018 May 25;19(1):101. doi: 10.1186/s12931-018-0808-x.
PubMed 29801506Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
PubMed 10377201Hewlett S, Dures E, Almeida C. Measures of fatigue: Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF MDQ), Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF NRS) for severity, effect, and coping, Chalder Fatigue Questionnaire (CFQ), Checklist Individual Strength (CIS20R and CIS8R), Fatigue Severity Scale (FSS), Functional Assessment Chronic Illness Therapy (Fatigue) (FACIT-F), Multi-Dimensional Assessment of Fatigue (MAF), Multi-Dimensional Fatigue Inventory (MFI), Pediatric Quality Of Life (PedsQL) Multi-Dimensional Fatigue Scale, Profile of Fatigue (ProF), Short Form 36 Vitality Subscale (SF-36 VT), and Visual Analog Scales (VAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S263-86. doi: 10.1002/acr.20579. No abstract available.
PubMed 22588750Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
PubMed 11832252
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Post Coronavirus (COVID-19). a Longitudinal Study
- ClinicalTrials.gov ID
- NCT04768257
- Acronym / sponsor ID
- PA-COVID19 / CEID/HU/2020/51
- Conditions
- Covid19
- Keywords
- Covid19, Physical activity, Exercise capacity, Functional capacity, Long COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Collaborators
- Professional College of Physiotherapists of the Community of Madrid (CPFCM), University of Guadalajara
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID-19, treated in intensive care | – | Behavioral: Physical activity |
| Patients with COVID-19, treated in hospital ward | – | Behavioral: Physical activity |
| Patients with COVID-19, treated at home | – | Behavioral: Physical activity |
| 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityWe 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). | Behavioural | Patients with COVID-19, treated at home, Patients with COVID-19, treated in hospital ward, Patients with COVID-19, treated in intensive care |
Primary outcome
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) 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 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).
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 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 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 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.
15 secondary outcomes
Change in isometric quadriceps strength from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
Time frame: 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
Time frame: 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
Time frame: Baseline, 12 weeks and 6 months
Change in health-related quality of life from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
Time frame: 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
Time frame: 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
Time frame: Baseline, 12 weeks and 6 months
Change in anxiety and depression symptoms from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
Time frame: 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)
Time frame: Baseline
Forced vital capacity (FVC) assessed using spirometry at baseline (at hospital discharge or patient's home)
Time frame: Baseline
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)
Time frame: Baseline
Sociodemographics (age) at baseline (at hospital discharge or patient's home)
Time frame: Baseline
Sociodemographics (sex) at baseline (at hospital discharge or patient's home)
Time frame: Baseline
Anthropometrics (height) at baseline (at hospital discharge or patient's home)
Time frame: Baseline
Change in anthropometrics (weight) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months
Time frame: Baseline, 12 weeks and 6 months
Relevant clinical history (diagnosis with lung or cardiovascular disease) at baseline
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 23397303Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8.
- Background: PubMed 24603844Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.
- Background: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Background: PubMed 7624188Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.
- Background: PubMed 7849749Deones VL, Wiley SC, Worrell T. Assessment of quadriceps muscle performance by a hand-held dynamometer and an isokinetic dynamometer. J Orthop Sports Phys Ther. 1994 Dec;20(6):296-301. doi: 10.2519/jospt.1994.20.6.296.
- Background: PubMed 18796752Hamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9. doi: 10.2519/jospt.1992.16.5.215.
- Background: PubMed 29801506Szentes BL, Kreuter M, Bahmer T, Birring SS, Claussen M, Waelscher J, Leidl R, Schwarzkopf L. Quality of life assessment in interstitial lung diseases:a comparison of the disease-specific K-BILD with the generic EQ-5D-5L. Respir Res. 2018 May 25;19(1):101. doi: 10.1186/s12931-018-0808-x.
- Background: PubMed 10377201Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
- Background: PubMed 22588750Hewlett S, Dures E, Almeida C. Measures of fatigue: Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF MDQ), Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF NRS) for severity, effect, and coping, Chalder Fatigue Questionnaire (CFQ), Checklist Individual Strength (CIS20R and CIS8R), Fatigue Severity Scale (FSS), Functional Assessment Chronic Illness Therapy (Fatigue) (FACIT-F), Multi-Dimensional Assessment of Fatigue (MAF), Multi-Dimensional Fatigue Inventory (MFI), Pediatric Quality Of Life (PedsQL) Multi-Dimensional Fatigue Scale, Profile of Fatigue (ProF), Short Form 36 Vitality Subscale (SF-36 VT), and Visual Analog Scales (VAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S263-86. doi: 10.1002/acr.20579. No abstract available.
- Background: PubMed 11832252Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
- Individual participant dataSharing planned: Yes. Data will be shared after drafting the final version of the database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Sante Diciolla, PT, MSc principal investigator
University of Alcalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04768257, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.