Physical Activity Post COVID-19

NCT04768257 | Completed

• 1 other identifier: CEID/HU/2020/51
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Covid19; Physical activity; Exercise capacity; Functional capacity; Long COVID

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (15)

• 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 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

Study Arms (5)

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

Interventions

Physical activity BEHAVIORAL

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).

Patients with COVID-19, treated at home; Patients with COVID-19, treated in hospital ward; Patients with COVID-19, treated in intensive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• Vacination before infection.
• Reinfections during follow-up.

Sponsors & Collaborators

• University of Alcala: lead
• Professional College of Physiotherapists of the Community of Madrid (CPFCM): collaborator
• University Hospital of Guadalajara (HUGU): collaborator

Study Sites (1)

University Hospital of Guadalajara

Guadalajara, Castille-La Mancha, 19002, Spain

Location

Related Publications (10)

• 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.

  PMID: 23397303 BACKGROUND

• 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.

  PMID: 24603844 BACKGROUND

• 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.

  PMID: 25359355 BACKGROUND

• 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.

  PMID: 7624188 BACKGROUND

• 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.

  PMID: 7849749 BACKGROUND

• 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.

  PMID: 18796752 BACKGROUND

• 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.

  PMID: 29801506 BACKGROUND

• 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.

  PMID: 10377201 BACKGROUND

• 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.

  PMID: 22588750 BACKGROUND

• 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.

  PMID: 11832252 BACKGROUND

MeSH Terms

Conditions

COVID-19; Motor Activity; Post-Acute COVID-19 Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nicola Sante Diciolla, PT, MSc

  University of Alcalá

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher, PhD Student

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available once the final version of the database will be considered completed for one year.

Locations

ES (1)