Feasibility, of Tele-rehabilitation Following COVID-19

NCT04511962 | Active Not Recruiting

• 1 other identifier: 285205
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• How many people that have been admitted to hospital and needed intensive care treatment for COVID-19 still report breathlessness, fatigue, cough and limitation of activities after being discharged from hospital?
• Is it possible to recruit these people to a trial of tele-rehabilitation after hospital discharge?
• Are people willing and able to perform tele-rehabilitation in their own home using video-link to connect with their therapist?
• Are there other rehabilitation needs that are commonly encountered by people requiring intensive care treatment for COVID-19 that could be addressed by tele-rehabilitation that the programme doesn't currently address? Investigators will perform a small study called a feasibility trial to answer these questions and gather some early information about possible benefits of tele-rehabilitation. Based on our understanding of other similar diseases, doctors and therapists think that people will benefit from rehabilitation after COVID-19. The investigators therefore want to test a trial design that makes sure that everyone gets the treatment. This type of trial is called a feasibility, wait-list design randomised controlled trial. People with breathlessness and some limitation of activities will be selected at random to receive tele-rehabilitation within 2 weeks or to wait 6-8 weeks before starting. how many people were eligible to take part, how many agreed to take part and the symptoms and rehabilitation needs that they have will be assessed. Investigators will then monitor symptoms and ability to exercise at the start and end of the trial and before and after tele-rehabilitation.

Conditions

Pulmonary Disease

Keywords

rehabilitation, covid19

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

Fast track group

Participants randomised to the fast track group will receive the pulmonary rehabilitation intervention 14 ± 7 days after randomisation.

Other: Tele-Pulmonary rehabilitation

Wait list group

Participants randomised to the wait-list group will receive the pulmonary rehabilitation intervention 56 ± 7 days after randomisation.

Other: Tele-Pulmonary rehabilitation

Interventions

Tele-Pulmonary rehabilitation OTHER

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.

Fast track group; Wait list group

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• \) Males and females aged ≥18 years.
• \) Suspected or confirmed COVID-19 requiring hospitalisation and either i) non- invasive respiratory support \[CPAP, HFNO, NIV\] or ii) invasive mechanical ventilation within 3 months of study recruitment.
• \) \> 4 weeks since hospital discharge / first positive COVID-19 swab (whichever is later) at time of screening
• \) mMRC dyspnoea grades 2 or more.
• \) Perceived limitation of activities compared with prior to COVID-19 hospitalisation (patient or investigators perception).
• \) Internet connection and access to a device that supports video calling.
• \) Able to give informed consent

You may not qualify if:

• \- 1) Significant comorbid physical or mental illness considered by the investigator to:
• \) prevent engagement in modified exercise,
• \) impair the participants ability to follow instructions
• \) place the participant at undue risk during exercise training
• \) adversely affect the recovery or rehabilitation trajectory
• Unwilling or unable to consent or complete study measures.
• Current involvement in other interventional clinical trials relating to COVID-19 (e.g. clinical trial of an investigational medicinal product)

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Castle Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Related Publications (12)

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MeSH Terms

Conditions

Lung Diseases; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 13, 2020
• Study Start: August 24, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2025
• Last Updated: May 25, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)