Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000355774
Ethics application status
Approved
Date submitted
9/02/2022
Date registered
28/02/2022
Date last updated
20/06/2024
Date data sharing statement initially provided
28/02/2022
Date results information initially provided
20/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a four week telerehabilitation program improve exercise capacity compared to receiving usual medical care in people who have persistent symptoms consistent with a previous COVID-19 infection?
Scientific title
The effect on exercise capacity of a four week telerehabilitation program compared to usual care in people who were hospitalised or treated in the community for COVID-19 and who have persistent symptoms consistent with a previous COVID infection: a randomised controlled trial (COVID-Rehab trial).
Secondary ID [1] 306149 0
Nil known
Universal Trial Number (UTN)
Trial acronym
COVID-rehab
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post COVID-19 325129 0
Condition category
Condition code
Infection 322535 322535 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive pulmonary rehabilitation via telehealth supervised twice per week for 4 weeks by a physiotherapist experienced in exercise rehabilitation via remote supervision (telerehabilitation). All participants in this group will meet individually via videoconference with the physiotherapist for their first session so that any issues with the safety of the home environment can be addressed and an individualised exercise program can be prescribed and tested.

Aerobic exercise training will be walking and calisthenics of a prescribed intensity of maintaining breathlessness or fatigue (whichever is the highest) at 3 (moderate) to 4 (somewhat severe) on the 0-10 category ratio scale (Borg 1998). Strength training will be using body weight (squats, sit-to-stand, hand weights [cans of food, bags of rice etc] or resistance bands). The exercise program will be in groups no greater than 4-5 participants who will all be visible on the computer screen. The exercise session will be for 40 minutes. Before commencing exercise, participants will be asked to self-check if they have any change in how they feel or any new symptoms and to inform the physiotherapist supervising the session. Participants will be advised to stop exercise if they have any concerns or experience a change in symptoms or if the exercise causes ‘severe’ breathlessness or fatigue. At the next session, participants will be asked to report how they felt after the exercise, especially about their levels of breathlessness and feelings of fatigue. If fatigue was worse, the exercises will be adjusted to be a lower intensity or more rests will be included. An Australian case series of post-COVID patients has demonstrated that rehabilitation via videoconferencing was feasible and safe (Wootton et al, 2020). Adherence to the exercise sessions will be monitored by recording attendance at the telerehabilitation sessions.
An education program will be provided for 30 minutes once a week at the conclusion of the exercise session. Education sessions will include strategies to manage fatigue; eating well; managing daily activities; staying physically active; managing anxiety and depression; and return to work. The education will be provided by the physiotherapist and will be based on the World Health Organisation’s Pamphlet Support for rehabilitation: self-management after COVID-19-related illness (WHO 2021).
Intervention code [1] 322769 0
Rehabilitation
Comparator / control treatment
The control group will receive usual medical care. ‘Usual medical care’ will be any care that the treating physician considers appropriate, excluding exercise rehabilitation.
At the end of the 4 weeks and after completing the assessments, any participant in the control group who still has symptoms will be invited to cross-over into the telerehabilitation program and will be resassessed at the end of the 4-week program.
Control group
Active

Outcomes
Primary outcome [1] 330326 0
Functional exercise capacity measured by the 1-minute sit-to-stand test.
Timepoint [1] 330326 0
Prior to and at the completion of the 4 week intervention or control period and at 12-month follow-up
Secondary outcome [1] 405843 0
Physical component score of the SF-36 quality of life questionnaire;
Timepoint [1] 405843 0
Prior to and at the completion of the 4 week intervention or control period and at 12-month follow-up
Secondary outcome [2] 405844 0
Functional lower limb strength measured by the 5 repetition sit-to-stand test
Timepoint [2] 405844 0
Prior to and at the completion of the 4 week intervention or control period and at 12-month follow-up
Secondary outcome [3] 405845 0
Quality of life measured by SF-36
Timepoint [3] 405845 0
Prior to and at the completion of the 4 week intervention or control period and at 12-month follow-up
Secondary outcome [4] 405846 0
Symptoms based on Yorkshire Rehabilitation Assessment Survey
Timepoint [4] 405846 0
Prior to and at the completion of the 4 week intervention or control period and at 12-months follow-up
Secondary outcome [5] 405847 0
COPD Assessment Test (CAT)
Timepoint [5] 405847 0
Prior to and at the completion of the 4 week intervention or control period and at 12-months follow up.
Secondary outcome [6] 405848 0
Hospital Anxiety and Depression Scale
Timepoint [6] 405848 0
Prior to and at the completion of the 4 week intervention or control period and at 12-month follow-up
Secondary outcome [7] 405849 0
Fatigue measured by the fatigue severity scale (FSS
Timepoint [7] 405849 0
Prior to and at the completion of the 4 week intervention or control period and at 12-months follow-up
Secondary outcome [8] 405850 0
Cognitive impairment measured by the Montreal Cognitive Assessment (MoCA-BLIND) test (telephone version)
Timepoint [8] 405850 0
Prior to and at the completion of the 4 week intervention or control period and at 12-month follow-up
Secondary outcome [9] 436562 0
Focus interviews of a random sample of participants who complete the telerehabilitation intervention.
Timepoint [9] 436562 0
Interviews will take place between immediately post intervention up to a maximum of 2 months post intervention.
Secondary outcome [10] 436563 0
Return-to-work questions from the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) questionnaire
Timepoint [10] 436563 0
Interviews will take place between immediately post intervention up to a maximum of 2 months post intervention.
Secondary outcome [11] 436564 0
Return-to-work questions from the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) questionnaire
Timepoint [11] 436564 0
At 12-month follow-up
Secondary outcome [12] 436565 0
Return-to-work questions from the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) questionnaire
Timepoint [12] 436565 0
At 12-month follow-up
Secondary outcome [13] 436566 0
Return-to-work questions from the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) questionnaire
Timepoint [13] 436566 0
at 12-month follow-up
Secondary outcome [14] 436567 0
Kessler Psychological Distress Scale (K6+).
Timepoint [14] 436567 0
at 12-month follow-up
Secondary outcome [15] 436568 0
Kessler Psychological Distress Scale (K6+).
Timepoint [15] 436568 0
Prior to and at completion of the 4 week intervention or control period and at 12 month follow-up

Eligibility
Key inclusion criteria
1. People diagnosed with COVID-19 who were hospitalised due to the severity of their COVID-19 infection and who attend a Post-COVID Respiratory Clinic at RPAH or Concord Hospital or people diagnosed with COVID-19 and who were managed in the community, either at home or by virtual care.
2. Ongoing symptoms consistent with post-COVID sequelae
3. Sex: All genders
4. Age range: greater than or equal to 18 years old
5. Identified by treating physician as suitable for rehabilitation
6. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. People with severe COVID-19 requiring long stay ICU who develop post-ICU syndrome. These people need rehabilitation and therefore should not be in a RCT in which they may be randomised to no rehabilitation.
2. People with acute symptoms of any illness where exercise is not recommended
3. People who are not medically stable as judged by treating physician
4. Women who are pregnant or post-partum
5. No access to appropriate technology (e.g internet, computer or tablet)
6. Difficulty understanding English and unable to access an interpreter
7. Severe cognitive impairment or other comorbidities which would make exercise unsafe, as assessed by the referring physician

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be via a central REDCap randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be via a central REDCap randomisation using a computerised sequence generator with stratification for sex (male/female) and age (less than or equal to 50 years or > 50 years).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
42 patients will be required to have an 80% chance of detecting, as significant at the 5% level, a difference of 3.5 repetitions, which is minimal important difference (Vaidya et al 2016,) in the 1-minute sit-to-stand test in the rehabilitation group compared with the control group, SD 4 repetitions. To account for a 15% dropout, 48 participants will be recruited.

Data will be analysed for within group and between group changes using linear mixed effects model ANOVA..

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/03/2022
Actual
6/03/2022
Date of last participant enrolment
Anticipated
18/11/2022
Actual
30/06/2023
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
48
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21631 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 21632 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 21633 0
Canterbury Hospital - Campsie
Recruitment hospital [4] 21634 0
Balmain Hospital - Balmain
Recruitment postcode(s) [1] 36563 0
2041 - Balmain
Recruitment postcode(s) [2] 36560 0
2050 - Camperdown
Recruitment postcode(s) [3] 36561 0
2139 - Concord
Recruitment postcode(s) [4] 36562 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 310490 0
Government body
Name [1] 310490 0
Sydney Local Health District
Country [1] 310490 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Missenden Road, Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 311909 0
None
Name [1] 311909 0
Address [1] 311909 0
Country [1] 311909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310119 0
Sydney Local Health District Ethics Review Committee (RPAH zone)
Ethics committee address [1] 310119 0
RESEARCH ETHICS AND GOVERNANCE OFFICE
ROYAL PRINCE ALFRED HOSPITAL
Missenden Road
Camperdown
NSW 2050
Ethics committee country [1] 310119 0
Australia
Date submitted for ethics approval [1] 310119 0
08/12/2021
Approval date [1] 310119 0
21/01/2022
Ethics approval number [1] 310119 0
X21-0460

Summary
Brief summary
The primary objective of the Post-COVID Early Rehabilitation Trial is:
To determine whether a 4-week telerehabilitation program for people post hospital discharge or who were managed in the community and who have persistent symptoms following COVID-19 infection, improves physical function and symptoms compared to usual medical care. The hypothesis is that people who receive a four-week telerehabilitation program post COVID infection, will improve physical function and symptoms more than those who receive usual medical care.

People who meet the inclusion criteria will be invited to participate in a study comparing a 4-week, twice weekly, program of telerehabilitation with 4-weeks of usual medical care. Following consent and initial assessment of physical function, quality of life, symptoms, anxiety, depression, and cognition, participants will be randomised using stratification for sex (male/female) and age (less than or equal to 50 years or > 50 years). At the end of the 4 weeks all participants will be reassessed by an assessor blind to group allocation. The participants will be asked not to divulge to the assessor the group to which they were allocated, and the assessor will be asked not to seek this information. All the same measures taken at initial assessment will be repeated. Participants originally randomised to the control group of usual care will be invited to crossover into the intervention group of telerehabilitation. All the same assessments will be repeated at the end of the telerehabilitation period by an assessor blind to group allocation. All participants will be invited for follow-up assessment at 12-months after completion of the intervention or control periods to assess the longer term outcomes. At this timepoint all the same assessments will be repeated and one additional questionnaire to collect information about return-to-work.
A random sample of people randomised into the telerehabilitation group will be invited to participate in a focussed interview to gain an in-depth understanding of their experiences of the telerehabilitation. It is anticipated that 20 people will be interviewed or until no new themes emerge.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116542 0
Prof Jennifer Alison
Address 116542 0
Faculty of Medicine and Health
Sydney School of Health Sciences
Susan Wakil Health Building
The University of Sydney
Camperdown
NSW 2006
Country 116542 0
Australia
Phone 116542 0
+61 414300416
Fax 116542 0
Email 116542 0
jennifer.alison@sydney.edu.au
Contact person for public queries
Name 116543 0
Prof Jennifer Alison
Address 116543 0
Faculty of Medicine and Health
Sydney School of Health Sciences
Susan Wakil Health Building
The University of Sydney
Camperdown
NSW 2006
Country 116543 0
Australia
Phone 116543 0
+61 414300416
Fax 116543 0
Email 116543 0
jennifer.alison@sydney.edu.au
Contact person for scientific queries
Name 116544 0
Prof Jennifer Alison
Address 116544 0
Faculty of Medicine and Health
Sydney School of Health Sciences
Susan Wakil Health Building
The University of Sydney
Camperdown
NSW 2006
Country 116544 0
Australia
Phone 116544 0
+61 414300416
Fax 116544 0
Email 116544 0
jennifer.alison@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval will need to be sought if participant data is to be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.