Tasman Medical Journal

ISSN: 2652-1881

Life AfTER covid-19 (LATER-19): a protocol for a prospective, longitudinal, cohort study of symptoms, physical function and psychological outcomes in the context of a pandemic

Dale W Edgar, Paul Gittings, Lisa van der Lee, Louise Naylor, Andrew Maiorana, Angela Jacques and Vinicius Cavalheri


Introduction (COVID-19) disease can present with respiratory tract infection and influenza-like symptoms. Although increased symptoms during physical exertion and impairments in lung function have been recently reported as some of the negative effects of COVID-19, no study has defined the recovery trajectories during and following the acute phase of the disease from a symptomatic, physical or psychological perspective. The proposed study will aim primarily to provide a multidimensional analysis of the 12-month recovery of symptoms, physical function, health-related quality of life (HRQoL), and psychological function in adults following a diagnosis of COVID-19.

Methods This report describes the method for a prospective, longitudinal, single-area multi-centre cohort study. Possible international extension is envisaged. Eligibility criteria are patients > 18 years old with a confirmed diagnosis of COVID-19, who provide informed consent. Exclusion criteria include those with pre-existing neuromuscular disorders likely to affect the measures of physical function, diagnosed pre-existing mental illness and significant cognitive impairment likely to affect responses to self-report measures. The study assessment protocol is in two parts. Part A will be undertaken by inpatients, who will undergo added clinical and symptom assessments every 48 hours during the admission. At discharge, participants will be eligible for Part B, incorporating assessments at four time points: on discharge and 3, 6, and 12 months from hospital admission. Assessments will include: symptoms (fatigue and shortness of breath), physical function (functional capacity and peripheral muscle force), HRQoL and psychological (feelings of anxiety and depression, and posttraumatic stress) function. Associations of patient and clinical characteristics predictors with longitudinal in-hospital clinical and symptomatic outcomes will be examined using generalised linear mixed models (GLMM) with random subject effects. Corresponding associations of patient characteristic, clinical pathway and rehabilitation pathway predictors with recovery trajectories will also be examined.

Full Text


Patients infected with SARS-CoV-2 (COVID-19 disease) present with respiratory tract infection and symptoms such as fever, cough, fatigue, sputum production and/or breathlessness.1 The spectrum of COVID-19 varies from asymptomatic infection through mild upper respiratory tract illness, to severe and potentially fatal viral pneumonia with respiratory failure. The Chinese Centre for Disease Control and Prevention reported that 70,420 of the 80,928 confirmed cases in China are “cured and discharged from hospital,” while 3,245 have died.2  However, in the early stage of this pandemic, and due mainly to the lack of understanding of the properties of the virus, inadequate medical protection, high infectivity and absence of effective treatment  there was a dramatic increase in the number of patients exceeding medical resources. As a result, the initial patient discharge rate was reported to be relatively low.3 Scientists and health care workers around the world are working to improve treatments in order to reduce mortality, and improved recovery rates are anticipated.  Chronic morbidity due to permanent organ damage in some patients is likely, and many patients who have recovered from the acute illness will need ongoing health care and allied health support.

Twenty-three percent of patients with severe acute respiratory syndrome caused by SARS-CoV-1 (SARS) had impaired lung function and a reduced exercise capacity after 1 year compared to normal predicted values.4,5  Similarly, there is a strong suggestion of prolonged lung function deficits in some patients with COVID-19. A recently published study6 on 50 middle-aged (median [interquartile range] 54 y [46 to 62 y]; 44% female) patients reported that 27 (54%) had impaired lung function 30 days after the onset of symptoms.  In another study, 14 of 55 “recovered” COVID-19 patients had lung function abnormalities 3 months after resolution of the acute disease, and radiological abnormalities were present in 39 patients.7 Given the intensive medical management for people with severe loss of respiratory function including prolonged mechanical ventilation, sedation and use of neuromuscular blockade, these patients are likely to be at high risk of intensive care unit acquired weakness (ICU-AW).8  This disease has independent long-term effects on symptoms and physical function.9  It is therefore desirable to define the clinical trajectory in these patients so as to provide them with appropriate rehabilitative interventions from a symptomatic, physical and psychological perspective.

The primary aim of the proposed study is to therefore provide a multidimensional analysis of recovery over 12 months following diagnosis and hospital admission in adults with COVID-19, with possible extension if recovery trajectories are more prolonged.  The specific objectives are to document the duration of symptoms and the time course of physical and psychological recovery during and following the acute (in-hospital or at home) phase of the disease; detect risk factors for patients who deteriorate in spite of treatment; and identify factors and specific elements of pragmatic rehabilitation programs that are associated with recovery of symptoms (fatigue and shortness of breath), physical function (functional capacity and peripheral muscle force), HRQoL, feelings of anxiety and depression, and post-traumatic stress over 12 months.

This will be a prospective, longitudinal, multi-centre cohort study led by Allied Health staff at Fiona Stanley Hospital, in collaboration with Royal Perth Hospital and Sir Charles Gairdner Hospital in Perth, Western Australia (WA). It is designed to complement the Western Australian Health Translation Network (WAHTN) COVID Research Response (CRR).  The WAHTN is a state-wide collaborative network of WA’s universities, medical research institutes, public and private hospitals, PathWest and the WA Department of Health.  International collaboration is also a possibility.

Eligibility Criteria
Adults > 18 years of age and who have tested positive for COVID-19 admitted to the participating hospitals will be eligible to participate. Informed consent will be sought.  Exclusion criteria will be pre-existing neuromuscular disorders thought to affect the measures of physical function or known mental illness, or significant communication or cognitive impairment thought to affect responses to self-report measures.  Participants will be given a unique study ID, and may withdraw consent at any time, but data accumulated to that point will be retained with assent from the patient.

Outcome assessment Protocol and Timeline
This study assessment protocol has been designed in two parts. The participant flow through this study’s assessment protocol is outlined in Figure 1. The outcome assessment protocol is outlined in Table 1.

Outcomes and Measures
A detailed description of the tests and tools used to assess each outcome measure in Parts A and B is included in the Supplementary Information (after references).

Part A: Acute Hospital Period
Part A will be undertaken by participants during their hospital stay. They will receive standard treatment but will have additional clinical and symptom assessments every 48 hours. The assessments will be performed via phone communication with the participant (who will be in isolation); with the assistance of the attending nurse and/or from distant observation of participant’s performance (in the tests related to physical function) via a glass window.  This will be on a case-by-case basis.  In the case of patient admission to the intensive care unit (ICU) and the need for mechanical ventilation, the assessments will not be attempted while intubated but will resume following extubation from mechanical ventilation in ICU.  Routine collection of symptoms and an abridged physical assessment will provide valuable insight into the acute course of the disease to the development of adaptive algorithms to predict those who deteriorate. The first assessment will occur on recruitment and will be completed every 48 hours during the hospital stay.

Symptoms of fatigue and shortness of breath will be assessed using The Edmonton Symptom Assessment Scale (ESAS).10,11 The physical assessments will comprise measures of functional capacity, using the 1-minute sit-to-stand test (1STS),12 and peripheral muscle power (handgrip power) measured using a hydraulic hand dynamometer (Jamar; JA Preston Corporation; MI, USA).13   In view of the safety challenges and physical distancing requirements for COVID-19 positive patients, the physical testing has been abridged to clinical tests which can be completed by researchers and treating clinicians (physiotherapists or nurses).

Part B: Discharge to 12 months
Participants will undergo assessments (Table 1) at four time points T1 – T4: T1, at hospital discharge; T2, T3 and T4, at 3, 6 12 months dated from the date of admission. Part B assessments T2 to T4 will be performed either in person, or via the use of electronic data capture including telehealth systems, REDCap electronic data capture tool and/or the South Metropolitan Health Service Virtual Clinic System (VCS) (data capture via smartphone). 

From T1 to T4 measures to be collected are: (i) functional capacity by the 1STS (face-to-face if the participant remains in contact with clinical services, or remotely by video link); (ii) fatigue related to activities by the Fatigue Severity Scale (FSS);14 (iii) shortness of breath during activities by the Modified Medical Research Council Dyspnoea Scale (MMRC);15 (iv) health-related quality of life by the EuroQol 5 dimensions – five response level (EQ-5D-5L);16 (v) feelings of anxiety and depression: Hospital Anxiety and Depression Scale (HADS);17 and (vi) posttraumatic stress: Impact of Events Scale–6 (IES-6).18,19

Table 1. Study outcome assessment protocol.  *Collected in patients with ≥7 days of length of hospital stay; α Sit-to-stand and peripheral muscle power collected where feasible in person or using video conference.   ISARIC = International Severe Acute Respiratory and emerging Infection Consortium (https://isaric.tghn.org/); T1, at discharge; T2, T3, and T4: at 3, 6 and 12 m after initial presentation.

Clinical data and other information
Clinical data will be available in the form of Tier 0 clinical data as per the ISARIC / WHO RAPID minimum dataset (https://isaric.tghn.org/COVID-19-CRF/) captured during the WAHTN COVID-19 Research Response program. The data will consist of patient demographics (age, gender, body-mass index at admission), pre-existing comorbidities, short term outcomes such as number of days in intensive care unit, duration of mechanical ventilation, length of hospital stay, recorded mobility status (average distance walked per day), and average daily distance during hospital stay.  These data will assist predictive modelling and to identify factors affecting clinical variability after hospital discharge.  At T2, patients will be asked to provide a total number of days in isolation as well as information on use of so-called “wellbeing apps” (exercise, mindfulness, meditation, etc.).

Data management
Study data will be recorded and held electronically in the REDCap electronic data capture tool hosted at the Department of Health Western Australia.20,21 REDCap is a secure, web-based software platform designed to support data capture for research projects. This data will only be accessible to the recruiters and senior co-investigators who have established and, or been granted permission to access the database.  

Sample size and statistical analysis plan
In this observational trial all suspected and proven COVID-19 positive inpatients in each facility will be given the opportunity to join the study. A 50% recruitment rate is envisaged, owing to the complexity of engaging patients in isolation and availability of recruitment staff resources.

Descriptive summaries will include mean ± SD or median [interquartile range] for continuous data, and frequency distributions for categorical data [counts or percentage].  Comparisons of patient baseline characteristics (gender, age, comorbidities) and clinical characteristic data by disease severity (mild or severe/critical) will be undertaken using parametric independent t-tests or oneway ANOVA for normally distributed continuous data and non-parametric Mann-Whitney U or Kruskall-Wallis H tests for continuous data not confirmed to display a normal distribution.  Chi-squared or Fisher’s Exact tests, as appropriate, will be applied for categorical data.

Associations of patient and clinical characteristic predictors with longitudinal in-hospital symptomatic and physical functioning outcomes (including ESAS, 1STS, handgrip force) will be examined using generalised linear mixed models (GLMM) with random subject effects, adjusting for disease severity, length of stay in ICU and in hospital, and selected baseline (admission) characteristics. Associations of patient characteristic, clinical pathway and rehabilitation pathway predictors with post-discharge recovery trajectories (including 1STS, FSS, MMRC, EQ-5D-5L, HADS, IES-6 and clinical sequalae) will be examined using GLMM with random subject effects, adjusting for disease severity and selected baseline (discharge) characteristics. All models will be implemented as univariable and predictive multivariable models, with all covariates univariately significant at alpha=0.15 considered as candidate predictors in the multivariable models. Potential confounding variables informed by the literature will also be included in the multivariable models. Results will be summarised using estimated marginal means and 95% CI for continuous outcomes or odds ratios (OR) and 95% CI for categorical outcomes. Model fit will be assessed using residuals checking and cross-validation of models will be undertaken by splitting the dataset to form training and test sets if the sample is large.  Missing data points in longitudinal data will be accounted for by the use of maximum likelihood estimation (MLE) methods in the models. Temporal outcomes including time to death and time to discharge in the in-hospital analysis and time to reach recovery milestones, defined according to EQ5D age and gender appropriate norms, in post-discharge analysis will be assessed using Kaplan-Meier survival probabilities and compared between relevant patient characteristic, clinical pathway and rehabilitation pathway predictors using Log rank tests.  Effects of these predictors on temporal outcomes will be examined using Cox proportional hazards regression models, censoring at 12 months post-admission and adjusting for relevant baseline patient and clinical characteristics.  Results will be summarised using hazard ratios (HR) and 95% CI. Sensitivity analyses will be performed on patients who are engaged in any other forms of exercise/wellbeing apps/activities and those who are not. Stata MP version 16.0 (StataCorp LP, College Station, TX) will be used for data analysis.  All hypotheses will be two-sided and significance will be set at alpha = 0.05. All analyses will be conducted by senior biostatisticians (coinvestigators AJ and HJC).

Provenance: Externally reviewed
Ethics & Dissemination: The protocol has been granted Ethical approval by the South Metropolitan Health Service Human Research Ethics Committee (HREC) (REG 0000004040), with reciprocal approval at the other sites.  Results will be published after peer review and disseminated in the community by the consumer group representatives in the LATER-19 advisory group.
Conflicts or declarations of interest:  None declared
Funding interests:  Supported by the WA Department of Health and the WA Health Translation Network (COVID-19 Research Grants Program).  EuroQOL has licensed use of the EQ-5D-5L.
Author Contribution: DWE, LN, AM, LVDL and VC contributed to study conception and design. PG obtained Ethical approval and wrote the initial manuscript. AJ prepared the statistical analysis. The LATER-19 Coinvestigator Group has advised regarding study design and development.

Corresponding author: Dale Edgar, Departments of Physiotherapy and Exercise Physiology, Fiona Stanley Hospital, Murdoch, Western Australia. dale.edgar@health.wa.gov.au


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Physical Testing Protocols

1 Minute Sit to Stand Protocol

This is a protocol for the 1 Minute Sit to Stand (STS) test. The testing procedures have been informed by recommendations from a systematic review of the literature,1 with adaptations for the clinical environment, research protocol and hospitalised patient acuity. The test should be completed as an activity ‘bundled’ with other care requirements to minimise risk and PPE use – please check with nursing and other team members if there is any in-room tasks or patient needs that can be attended to in conjunction with completing this test. The recorded details below have the potential to reflect the severity of impact of the disease state and allows those who cannot complete one STS independently to record an outcome on the test. The appropriateness of these categorisations of an effort of up to one STS are yet to be finalised. The weighting of the physical assistance necessary from others to complete the one stand during the time of the test, and the amount of supplemental oxygen required, are yet to be validated.


1x Chair with seat height 45 – 52cm (preferably without arm rests)

1x stop watch / timer

1x pulse oximeter

BORG and Fatigue (/10) scales – printed & to be left in room

PPE as required for self +/- patient, including gown, gloves and appropriate face mask for completing an aerosolising procedure.


This test should be administered face to face in the first instance. Patients within one week of initial symptoms of COVID-19 should have face to face testing. After this time the clinician may determine whether it can be safely administered from the patient window using the IPAD or phone, therefore minimising clinician risk and minimising use of PPE.

  1. Initial Screening
    1. Medical approval to conduct the test should be sought for patients who are in the acute phase of their condition. This should be recorded on the data sheet.
    2. Absolute contraindications to this test include:
      1. Raised troponin
      2. Resting heart rate >120 bpm
  • Abnormal / unstable baseline heart rhythms
  1. Oxygen requirement >4L / min (ie. not on nasal prongs)
  2. If there are any other concerns about the patient condition – please discuss performing this test with the medical team or a senior clinician.
  3. Initial Data Recording
    1. Current clinical observations – Heart rate, Respiratory rate, Blood pressure, Oxygen saturations (SpO2), Oxygen administered, Resting BORG and leg fatigue.
  1. Preparation
    1. If a patient is COVID-19 POSITIVE and a staff member is present in the room at the time of this test:
      1. The staff member should wear PPE as per the current policy for the location in which the test takes place
      2. The patient should wear a surgical mask as this is classed as an aerosolising procedure
    2. If a patient is COVID-19 NEGATIVE and a staff member is present during the test
      1. PPE should be worn as required for that individual
    3. Record the date of assessment on the data sheet.
    4. Ask the patient to sit in the bedside chair which is positioned against a wall or bed (so that chair is stable and not likely to move) and without wheels.
    5. Ask the patient to position themselves so that their feet are flat on the ground and the calf is forward of the seating surface. Arms are crossed over their chest.
    6. Ensure that tubes or lines attached to the patient are safely positioned.
    7. Demonstrate a sit to stand where possible.
  1. Instruct the patient:

“When I say go, I want you to repeatedly stand all the way up and sit down as many times as you can for 1 minute. You are aiming to do as many as you can in that minute. If you need to rest at any time, you are free to do so, however, you should resume as soon as you can.  If you get chest pain or dizziness, please sit down and inform me.  If I need you to stop for any other reason, I will ask you to stop…

… (If patient is monitoring their own SpO2 – insert here that the patient “should rest if it reaches <88% and recommence when it goes over 88%”)…

You are aiming to do as many sit-to-stand cycles as you can in 1 minute.”

  1. Perform the test
    1. Patient should remain on prescribed resting, or, prescribed exertional FiO2 during the test
    2. Give the patient a “GO” command and start the timer
    3. Do not provide encouragement but remind to stand up with full hip and knee extension as needed.
    4. Inform the patient when 30 seconds & 10 seconds remain in the test.
    5. Stop the test after 60 seconds.
  1. Stopping Criteria
    1. The patient should be instructed to rest when:
      1. SpO2 falls to less than 88% during the test. Patients can re-commence within the minute test when SpO2 is equal to or greater than 88%.
      2. HR response is of concern. Ie. ≥HR max (220-age) or beta-blocker resting HR +40
  • they report new chest pain or dizziness during the test
  1. Recording
    1. Record Oxygen requirements
    2. Count each repetition and mark on the score sheet.
      1. Full knee extension is recorded must be achieved for a repetition to be counted. Count each stand upon full knee extension.
    3. Record the number of repetitions following the “Original” unassisted protocol AND the number of “deviations” to the original protocol on the datasheet
    4. Record what deviations were taken (eg. Use of arms for balance, not full knee extension, or any other deviation)
    5. Record the number of rests required, duration of rests and reason for resting.
    6. If the patient requires physical assistance during the test – they score 0.
    7. Record the following for the patient rating of the test
      1. Lowest SpO2
      2. Highest heart rate
  • BORG (Dyspnoea & Leg Fatigue)
  1. Limiting factor for completing sit to stands
  2. Leg fatigue
  3. Please record any deviations to the protocol in the data sheet
  4. Post-test
    1. Recovery: Continuously monitor SpO­2 until return to baseline and record time taken to achieve baseline
    2. Any equipment that are to be removed from the room
      1. Should be double wiped with appropriate surface cleaner, if patient is COVID-19 POSITIVE.
      2. Should be cleaned with appropriate surface cleaner, if patient is COVID-19 NEGATIVE
    3. Enter data into the electronic data management system
    4. Please document any perceived issues, concerns or suggestions about the protocol – these will be collated and discussed regularly with the clinical teams whilst testing occurs.
    5. Please document this test in the medical record, including the following features.
      1. Number of sit to stands completed, plus assistance needed if any.
      2. FiO2 used
  • Lowest SpO2 during test
  1. Time to return to baseline SpO2 after the test
  2. Other observations recorded
  3. Any adverse events during the test
  • Reasons for ceasing the test
  • Any other details determined pertinent for the individual patient

Reference:  Bohannon RW, Crouch R. 1-Minute Sit-to-Stand Test: SYSTEMATIC REVIEW OF PROCEDURES, PERFORMANCE, AND CLINIMETRIC PROPERTIES. J Cardiopulm Rehabil Prev. 2019; 39: 2-8.


LATER-19 Co-investigator Group

Ann White (AW, WAHTN, consumer representative); Caitlin Vicary (CV, DoPT-RPH); Carol Watson (CW, DoPT-RPH, HoD); Caroline Roffman (CR, DoPT-RPH); Emma-Leigh Synnott (ELS, SRS-FSH); Hui Jun Chih (HJC, SoPH-CU); Ivan Lin (IL, WACRH); Ian Suttie (IS, RMS-FSH); Jade Larsson (JL, DoPT-RPH); Jane Pearce (JP, WAHTN, consumer representative); Jessica Tearne (JT, DoCP-FSH); Kristen Grove (KG, DoPT-RPH, Site Coordinator); Linda Woodhouse (LW, SoPTES-CU); Liz Hurn (LH, DoPT-SCGH, Site Coordinator); Megan Harrold (MH, SoPTES-CU); Mercedes Elliott (ME, DoPT-FSH); Peta Winship (PW, DoPT-FSH); Robyn Timms (RT, DoPT-FSH, HOD); Sheldon Wulff (SW, DoPT-RPH); Tracy Hebden-Todd (THT, DoPT-SCGH, HoD)


Group institutional Affiliations

SoPTES-CU – School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia; DoPT-FSH – Department of Physiotherapy, Fiona Stanley Hospital, South Metropolitan Health Service, Murdoch, Western Australia; DoPT-RPH – Department of Physiotherapy, Royal Perth Hospital/Royal Perth Bentley Group, East Metropolitan Health Service, Perth, Western Australia; SRS-FSH – State Rehabilitation Service, Fiona Stanley Hospital, South Metropolitan Health Service, Murdoch, Western Australia; RMS-FSH – Respiratory Medicine Service, Fiona Stanley Hospital, South Metropolitan Health Service, Murdoch, Western Australia; WACRH – Western Australian Centre for Rural Health, Geraldton Regional Aboriginal Medical Service, Western Australia; DoCPN-FSH – Department of Clinical Psychology and Neuropsychology, Fiona Stanley Hospital, South Metropolitan Health Service, Murdoch, Western Australia; SoPH-CU – School of Public Health, Curtin University, Bentley, Western Australia; Western Australian Health Translation Network, Perth, Western Australia; DoPT-SCGH – Department of Physiotherapy, Sir Charles Gardiner Hospital, North Metropolitan Health Service, Nedlands, Western Australia

Publication Categories


Assoc. Prof. Dale W Edgar

Senior Physiotherapist
Fiona Stanley Hospital

Dr Paul Gittings

Senior Physiotherapist
Fiona Stanley Hospital

Dr Lisa van der Lee

Senior Physiotherapist
Fiona Stanley Hospital

Assoc. Prof. Louise Naylor

Curtin University

Assoc. Prof. Andrew Maiorana

Curtin University

Ms Angela Jacques

Curtin University

Dr Vinicius Cavalheri

Senior Physiotherapist
Curtin University