Physical Activity Post COVID-19

Covid19 Clinical Trial

— PA-COVID19  

Official title:

Physical Activity Post Coronavirus (COVID-19). A Longitudinal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768257
• Other study ID #: CEID/HU/2020/51
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to characterize functional status and physical activity of patients with COVID-19 after hospital discharge.

Description:

Interested patients will be contacted and informed consent obtained. Then, participants will be assessed through a set of tests and questionnaires to register data regarding: physical activity; functional capacity; muscle strength; health-related quality of life; symptoms (dyspnea, fatigue, anxiety and depression); lung function; sociodemographics and anthropometrics. Data collection will occur at baseline (at discharge from hospital or at patients' home), at 12 weeks and 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
Spain	University Hospital of Guadalajara	Guadalajara	Castilla La Mancha

Sponsors (3)

Lead Sponsor	Collaborator
University of Alcala	Professional College of Physiotherapists of the Community of Madrid (CPFCM), University Hospital of Guadalajara (HUGU)

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Bestall 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. — View Citation

Bjelland 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. — View Citation

Bohannon 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. — View Citation

Demeyer 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. — View Citation

Deones 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. — View Citation

Hamilton 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. — View Citation

Hewlett 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. — View Citation

Holland 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. — View Citation

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. — View Citation

Szentes 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, 12 weeks and 6 months
Primary	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).	Baseline, 12 weeks and 6 months
Primary	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).	Baseline, 12 weeks and 6 months
Primary	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).	Baseline, 12 weeks and 6 months
Primary	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).	Baseline, 12 weeks and 6 months
Primary	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).	Baseline, 12 weeks and 6 months
Primary	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.	Baseline, 12 weeks and 6 months
Primary	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.	Baseline, 12 weeks and 6 months
Secondary	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.	Baseline, 12 weeks and 6 months
Secondary	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.	Baseline, 12 weeks and 6 months
Secondary	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.	Baseline, 12 weeks and 6 months
Secondary	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.	Baseline, 12 weeks and 6 months
Secondary	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.	Baseline, 12 weeks and 6 months
Secondary	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.	Baseline, 12 weeks and 6 months
Secondary	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.	Baseline, 12 weeks and 6 months
Secondary	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)	Baseline
Secondary	Forced vital capacity (FVC) assessed using spirometry at baseline (at hospital discharge or patient's home)	Forced vital capacity (FVC, milliliters)	Baseline
Secondary	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)	Baseline
Secondary	Sociodemographics (age) at baseline (at hospital discharge or patient's home)	Sociodemographics (age in years).	Baseline
Secondary	Sociodemographics (sex) at baseline (at hospital discharge or patient's home)	Sociodemographics (sex, assessed as male/female).	Baseline
Secondary	Anthropometrics (height) at baseline (at hospital discharge or patient's home)	Anthropometrics (height in meters).	Baseline
Secondary	Change in anthropometrics (weight) from baseline (at hospital discharge or patient's home) at 12 weeks and 6 months	Anthropometrics (weight in kilograms).	Baseline, 12 weeks and 6 months
Secondary	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).	Baseline