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A Feasibility, Randomised Controlled Trial of Tele-rehabilitation Following COVID-19
Sponsor study identifier
observational
40
1 country
1
Study Start
August 24, 2020
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Since initial reports of a novel coronavirus emerged from Hubei province, China, the world has been engulfed by a pandemic with over 3 million cases and 225,000 deaths by 30th April 2020. Health care systems around the world have struggled to cope with the number of patients presenting with COVID-19 (the disease caused by the SARS-CoV-2 virus). Although the majority of people infected with the virus have a mild disease, around 20% experience a more severe illness leading to hospital admission and sometimes require treatment in intensive care. People that survive severe COVID-19 are likely to have persistent health problems that would benefit from rehabilitation. Pulmonary rehabilitation (PR) is a multidisciplinary program which is designed to improve physical and social performance and is typically provided for people with chronic lung conditions. PR courses typically last 6-12 weeks with patients attending classes once or twice weekly and consist of exercise and education components. PR is known to improve symptoms (e.g. breathlessness), quality of life and ability to exercise in those with lung conditions. Breathlessness is a very common symptom reported by people presenting to hospital with COVID-19 and loss of physical fitness will be very common. Using existing pulmonary rehabilitation programmes as a model, we have developed a tele-rehabilitation programme (a programme that will be delivered using video link to overcome the challenges faced by social distancing and shielding advice) for people that have been critically ill with COVID-19. In order to prove whether people benefit from this tele-rehabilitation programme after being admitted to hospital following COVID-19 we would need to perform a large clinical trial. However, before doing this it is important for us to answer some key questions:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2020
Actual (reported)August 13, 2020
Actual (reported)August 24, 2020
Actual (reported)June 30, 2021
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Recruitment - contact to consent ratio
The proportion of the total patients contacted, that meet the intieligibility criteria and give consent to take part * Data quality: completion of clinical outcomes (questionnaires and other assessments) at each time point and patterns of missing data for the study measures. * Intervention: Adherence in delivery and uptake documented in the clinical record.
through study completion an average of a year
Recruitment - screen failure rate
The proportion of patients consented to the study that do not meet the eligibility criteria
through study completion an average of a year
Recruitment rate
The number patients recruited over the designated time frame
through study completion an average of a year
Recruitment retention
The proportion of consented patients that complete the study
through study completion an average of 16 months
The Modified Medical Research Council (MMRC) Dyspnoea Scale
8 weeks
Numerical Rating Scale (NRS) of breathlessness
8 weeks
Cough Visual analogue Scale (VAS)
8 weeks
EQ-5D-5L questionnaire
8 weeks
Hospital Anxiety and Depression scale
8 weeks
Participants randomised to the fast track group will receive the pulmonary rehabilitation intervention 14 ± 7 days after randomisation.
Participants randomised to the wait-list group will receive the pulmonary rehabilitation intervention 56 ± 7 days after randomisation.
The tele-rehabilitation programme will be delivered via an NHSX / NHS Digital approved commercial video conferencing application. It will comprise an initial assessment followed by 12 bespoke classes delivered by video link over a 6 week period. Participants will be advised to undertake exercises on 5 days each week.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients will be identified from those patients being contacted post hospitalisation at Hull University Teaching Hospitals NHS Trust due to Covid-19. Patients selected will be those still reporting breathlessness, fatigue, cough and limited activity.
Castle Hill Hospital
Cottingham, East Yorkshire, HU16 5JQ, United Kingdom
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First Submitted
August 5, 2020
First Posted
August 13, 2020
Study Start
August 24, 2020
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Contact the study team to confirm eligibility.
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Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 25, 2025
Record last verified: 2024-10
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