Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000031864
Ethics application status
Approved
Date submitted
4/01/2021
Date registered
15/01/2021
Date last updated
15/01/2021
Date data sharing statement initially provided
15/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Home-based virtual rehabililtation for people with persistent symptoms after COVID-19 disease (Long COVID-19)
Scientific title
A randomized controlled trial investigating the effect of home-based, virtual supervised pulmonary rehabilitation program on the exercise capacity of patients with persistent symptoms after COVID-19 disease: a substudy of the ADAPT COVID-19 study.
Secondary ID [1] 303088 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a sub-study of the ADAPT COVID-19 study (ACTRN12620000554965) for those participants that have been determined to have Long-COVID-19.

Health condition
Health condition(s) or problem(s) studied:
Long COVID-19 320171 0
Condition category
Condition code
Respiratory 318114 318114 0 0
Other respiratory disorders / diseases
Infection 318191 318191 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group will complete a twice/weekly rehabilitation program for eight weeks.
This will be physiotherapist led and delivered through videoconferencing technology in groups of 4-6 participants.
Exercise sessions will run for about an hour each and cover aerobic exercise (walking) and strengthening (such as sit to stand exercises) in a similar format to usual pulmonary rehabilitation. Participant's will exercise at a moderate level of exertion (either breathlessness or fatigue depending on participant's individual symptoms) and this will be monitored using 0-10 Borg dyspnoea and rate of perceived exertion scales.
Adherence to the intervention will be recorded by the physiotherapist during each session on an exercise log which will track the number of sessions attended, exercises completed and any relevant issues during the sessions such as technological limitations or changes in participant symptoms.
Intervention code [1] 319388 0
Rehabilitation
Comparator / control treatment
Control group will continue usual care for the eight week period and will not receive any specific exercise advice.
The control group will all be participants in the existing ADAPT study (ACTRN12620000554965) and will continue to attend other study appointments such as blood tests and any other things deemed relevant by their medical specialists and general practitioners but they will not be actively encouraged to participate in any rehabilitation program during the study period.
Control group
Active

Outcomes
Primary outcome [1] 326099 0
Exercise capacity measured by six minute walk test
Timepoint [1] 326099 0
Pre and post intervention (0 and 8 weeks)
Secondary outcome [1] 390123 0
Health related quality of life measured by St George Respiratory Questionnaire
Timepoint [1] 390123 0
Pre and post intervention (0 and 8 weeks)
Secondary outcome [2] 390124 0
Fatigue measured by FACIT-F
Timepoint [2] 390124 0
Pre and post intervention (0 and 8 weeks)
Secondary outcome [3] 390137 0
Lower limb muscle endurance using 1 minute sit to stand test
Timepoint [3] 390137 0
Pre and post intervention (0 and 8 weeks)
Secondary outcome [4] 390138 0
Muscle strength using handgrip dynamometry
Timepoint [4] 390138 0
Pre and post intervention (0 and 8 weeks)

Eligibility
Key inclusion criteria
• Adult patients (>16 years) consented to the ADAPT cohort study with laboratory confirmed SARS-CoV-2 PCR positive (ACTRN12620000554965)
• Long COVID-19 symptoms; defined as persistent symptoms of dyspnoea, chest pain or fatigue at follow up visit 4
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
o Patients that are unwilling or unable to participate in the supervised telerehabilitation program
o Those that have participated in a structured, supervised exercise program of at least 6 weeks in duration in the last 3 months (prior to enrollment in the Long COVID-19 rehabilitation study)
o People with other comorbid conditions that would prohibit participation in exercise training such as unstable cardiovascular disease
o People with pre-existing chronic lung disease (including COPD, bronchiectasis, interstitial lung disease) or chronic heart failure known to be amenable to pulmonary rehabilitation. This people will instead be referred to their local pulmonary or heart failure rehabilitation service
o People who have an immediate family or household member already enrolled in this trial to limit potential contamination of groups. If this is the case, the person will be offered the opportunity to participate in the exercise program at a later date, if desired, but their data will not be included in the analysis.

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)
Allocation will be concealed from study investigators during enrollment.
Allocation will be completed by an offsite member of staff that is otherwise not involved in the running of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming a mean 6-minute walk distance of 400m at baseline among the Long Covid-19 patients, an improvement of 40m with the intervention of home-based pulmonary rehabilitation compared to standard care would require a sample size of 16 participants per group to allow 80% power at a significance level of 0.05. The minimally clinically important difference for functional capacity measured by the 6-minute walk test is considered generally considered to be 30m among people with chronic respiratory disease.


Descriptive statistics will be summarised by median (IQR) and counts (%-total). Differences between groups will be compared using the Student’s T test for continuous variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/01/2021
Actual
Date of last participant enrolment
Anticipated
8/03/2021
Actual
Date of last data collection
Anticipated
7/06/2021
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18268 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 32337 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 307490 0
Hospital
Name [1] 307490 0
St Vincent's Hospital Sydney
Country [1] 307490 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria St, Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 308170 0
Hospital
Name [1] 308170 0
St Vincent's Private Hospital Sydney
Address [1] 308170 0
406 Victoria St, Darlinghurst, NSW 2010
Country [1] 308170 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307565 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 307565 0
Ethics committee country [1] 307565 0
Australia
Date submitted for ethics approval [1] 307565 0
Approval date [1] 307565 0
17/12/2020
Ethics approval number [1] 307565 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107694 0
Dr Anthony Byrne
Address 107694 0
St Vincent's Hospital
390 Victoria St, Darlinghurst, NSW, 2010
Country 107694 0
Australia
Phone 107694 0
+61 283826822
Fax 107694 0
Email 107694 0
[email protected]
Contact person for public queries
Name 107695 0
Anthony Byrne
Address 107695 0
St Vincent's Hospital
390 Victoria St, Darlinghurst, NSW, 2010
Country 107695 0
Australia
Phone 107695 0
+61 283821111
Fax 107695 0
Email 107695 0
[email protected]
Contact person for scientific queries
Name 107696 0
Anthony Byrne
Address 107696 0
St Vincent's Hospital
390 Victoria St, Darlinghurst, NSW, 2010
Country 107696 0
Australia
Phone 107696 0
+61 283821111
Fax 107696 0
Email 107696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.