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Completed

NCT Number: NCT06394921

Cardiopulmonary Exercise Tests in Patients With Long COVID

The value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings has been established in the last decade. CPET methods remain highly relevant in the COVID-19 endemic phase and should be used to assess those recovering from COVID-19 (SARS-CoV-2) infection. This diagnostic tool could play an integral role in disease prognostication and evaluate the integrative response to incremental exercise. Date from such assessments can enable practitioners to characterise cardio-respiratory fitness and identify reasons for physical impairment or abnormal cardio-respiratory function. More than 50% of patients admitted to hospital will experience cardiorespiratory issues and significant morbidity during their recovery and will require significant rehabilitative support. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function. Current approaches to rehabilitation are being developed on existing knowledge from Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS) related illness. These provide important insight but do not provide insight into the novel challenges provided by COVID-19.

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Key information

Conditions

Long COVID COVID Long-Haul COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ramaiah Medical College, Bengaluru, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Aged 18 to 65 years old
  • Diagnosed with COVID-19
  • Still suffering from symptoms of COVID-19, 3 months after initial infection
  • Sufficient English language comprehension and cognitive ability to understand the study protocol, give informed consent and follow instructions.

Exclusion criteria

  • • <18 years of age
  • Admitted to or received treatment from Intensive Care Units
  • Unconfirmed COVID-19 test diagnosis
  • Unable to understand verbal or written information in English
  • Achieving a grade 0 or 1 on the PCFS.
  • Unstable angina
  • Uncontrolled hypertension, that is, resting systolic blood pressure (SBP) >180mmHg, or resting diastolic blood pressure (BP) (DBP) >110mmHg
  • Orthostatic blood pressure drop of >20 mmHg with symptoms
  • Significant aortic stenosis (aortic valve area 120 bpm)
  • Acute pericarditis or myocarditis
  • Decompensated HF
  • Third degree (complete) atrioventricular (AV) block without pacemaker
  • Recent embolism
  • Acute thrombophlebitis
  • Resting ST segment displacement (>2 mm)
  • Uncontrolled diabetes mellitus
  • Severe orthopaedic conditions that would prohibit exercise
  • Other metabolic conditions, such as acute thyroiditis, hypokalaemia, hyperkalaemia or hypovolaemia (until adequately treated)
  • Severe grade 3 rejection (cardiac transplantation recipients Appendix N).

Treatment and study plan

2 day cardiopulmonary exercise test

Procedure

Consecutive day 2 day CPET and follow up for 7 days for subjective feelings/fatigue.

Primary outcomes

  1. Cardiopulmonary Exercise Test- Rate of Oxygen Utilisation

    Time frame: During CPET1 and CPET2

    Rate of Oxygen Utilisation (VO2; l/min)

  2. Cardiopulmonary Exercise Test- Rate of carbon dioxide production

    Time frame: During CPET1 and CPET2

    Rate of Carbon Dioxide Production (VCO2; l/min)

  3. Cardiopulmonary Exercise Test- Respiratory Exchange Ratio

    Time frame: During CPET1 and CPET2

    Respiratory Exchange Ratio (VO2/VCO2)

  4. Cardiopulmonary Exercise Test: Maximal Rate of Oxygen Utilisation

    Time frame: During CPET1 and CPET2

    Maximal Rate of Oxygen Utilisation per kg body mass (VO2max; ml/kg/min)

  5. Cardiopulmonary Exercise Test- Respiratory Threshold

    Time frame: During CPET1 and CPET2

    Respiratory Threshold breath by breath (l/min)

  6. Cardiopulmonary Exercise Test- Minute Ventilation

    Time frame: During CPET1 and CPET2

    Minute Ventilation using breath by breath (l/min)

  7. Cardiopulmonary Exercise Test- Blood lactate

    Time frame: During CPET1 and CPET2

    Blood Lactate Concentration from fingertip (mmol/l)

  8. Prevalence of symptoms of post exertional Malaise

    Time frame: 7 days post exercise

    Symptom Profile post exercise protocols- Questionnaire

Secondary outcomes

  1. Blood biomarkers of Inflammation- IL-6

    Time frame: Day 1 and Day 2

    Concentration of Interleukin 6

  2. Blood biomarkers of Inflammation- IL-1

    Time frame: Day 1 and Day 2

    Concentration of Interleukin 1

  3. Blood biomarkers of Inflammation- Microclots

    Time frame: Day 1 and Day 2

    Number of Microclots

  4. Blood biomarkers of Inflammation- D-Dimer

    Time frame: Day 1 and Day 2

    D-Dimer Concentration

  5. Blood biomarkers of Inflammation- CRP

    Time frame: Day 1 and Day 2

    C-Reactive protein Concentration

  6. Echocardiogram

    Time frame: Baseline, Day 1 and Day 2

    12 lead echocardiogram.

  7. Resting Systolic Blood Pressure

    Time frame: Baseline, Day 1 and Day 2

    Systolic Blood Pressure at Rest (mmHg)

  8. Resting Diastolic Blood Pressure

    Time frame: Baseline, Day 1 and Day 2

    Diastolic Blood Pressure at Rest (mmHg)

  9. Exercise Diastolic Blood Pressure

    Time frame: Baseline, Day 1 and Day 2

    Diastolic Blood Pressure During Exercise (mmHg)

  10. Exercise Systolic Blood Pressure

    Time frame: Baseline, Day 1 and Day 2

    Systolic Blood Pressure During Exercise (mmHg)

Other outcomes

  1. Symptom Profile Questionnaire

    Time frame: Baseline

    Description of previous and current symptom/s of Long COVID

  2. Quality of Life questionnaire

    Time frame: Baseline

    EQ-5D-5L

  3. Sleep Behavour

    Time frame: Baseline

    Pittsburgh Sleep Quality Index

  4. Fatigue Questionnaire- FAS

    Time frame: Baseline, Day 1 and Day 2

    Fatigue Assessment Scale

  5. Fatigue Questionnaire- MFI

    Time frame: Baseline, Day 1 and Day 2

    Multidimensional Fatigue Index (MFI-20)

  6. Medical Research Council Dyspnoea Scale

    Time frame: Baseline

    Breathlessness scale

  7. Post COVID-19 functional status Scale

    Time frame: Baseline

    Questionnaire to see effect of COVID-19 on physical function- 0= No Limitations; 4- Severe Limitations to function

  8. Cognition

    Time frame: Baseline

    Montreal cognitive assessment

  9. 6 minute walk

    Time frame: Baseline

    6 minute walk distance (metres)

  10. Timed Up and Go

    Time frame: Baseline

    5m timed up and go (seconds)

  11. Lung Function Assessment- FEV1

    Time frame: Baseline

    Forced Expiratory Volume in 1 Second (l)

  12. Lung Function Assessment- FVC

    Time frame: Baseline

    Forced Vital Capacity (l)

  13. Lung Function Assessment- PEF

    Time frame: Baseline

    Peak Expiratory Flow Rate (l/min)

  14. Lung Function Assessment- MIP

    Time frame: Baseline

    Maximal Inspiratory Pressure (mmHg)

  15. Lung Function Assessment- MEP

    Time frame: Baseline

    Maximal Expiratory Pressure (mmHg)

  16. Height

    Time frame: Baseline

    measurement of body stature (m)

  17. Weight

    Time frame: Baseline

    Measurement of body mass (kg)

  18. body mass index

    Time frame: Baseline

    weight and height will be combined to report BMI in kg/m^2

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Collaborators

  • King's College London
  • MS Ramaiah Medical College & Hospitals
  • Northumbria University
  • University of Derby
  • University of Illinois at Chicago
  • University of Nottingham

Registry information

Official study title

Interrogative Approaches Identify Causes of Physical Impairment in Those Affected by Post COVID-19 Morbidity (Long COVID) - an International Multicenter Observational Study

Acronym: PREPP-19

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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