Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000309886
Ethics application status
Approved
Date submitted
12/03/2021
Date registered
19/03/2021
Date last updated
19/03/2021
Date data sharing statement initially provided
19/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate effects of a respiratory telerehabilitation program in confined
patients affected by COVID-19
Scientific title
Immediate effects of a respiratory telerehabilitation program on mobility and level of exertion in confined patients affected by COVID-19
Secondary ID [1] 303487 0
Nil known
Universal Trial Number (UTN)
U1111-1265-8052
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 321001 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318808 318808 0 0
Physiotherapy
Respiratory 318978 318978 0 0
Other respiratory disorders / diseases
Infection 318979 318979 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Respiratory Exercise Program consisted of 10 exercises based on with scientific evidence, the method of active cycle of breathing techniques uses an alternate depth of breathing to move mucus from small airways at the bottom of the lungs to bigger airways, where they can be cleaned in an easier way by coughing. The exercises are available at https://www.fisiosurid.com/exercises-covid-19/ , it will be carried out once a day, for 14 days, at the patient’s home, depending on the score obtained on the Borg evaluation scale (BS), patients will perform 4 (BS 7-10) anticipated to take 10 minutes, 8 (BS 5-7) anticipated to take 20 minutes or 12 (BS 8-10) repetitions per exercises and day anticipated to take 30 minutes, this parameter may be modified in the intra-intervention evaluation. The exercise program will be reinforced by a physical therapist at least 2 times (1 time a week, if the patient does not require further attention), through telematic control by videoconference with each patient. Additionally, patients will receive a text message daily, asking about the exercises and as a method of follow-up and adherence.
Intervention code [1] 319980 0
Rehabilitation
Comparator / control treatment
No treatment is applied for the control group, the patients assigned to this group received usual care from the medical team, usual drugs for this disease, and the usual protocol.
Control group
Active

Outcomes
Primary outcome [1] 326825 0
Thirty Seconds Sit-To-Stand Test (30STST). Evaluators will ask patients to place a straight-backed armless chair, with a hard seat , which will be stabilized by placing it against a wall, considering floor to seat height will be between 45 - 50 cm. Seated participants will asked to come forward on the seat until their feet will be flat on the floor, and to fold their upper limbs across the chest, without moving it during all test. Patients will be then instructed to stand up all the way and sit down once without using the upper limbs. Patients will start in the seated position on the chair and, upon command telematically, they will stand up, and then they will return to sitting as many times as they could, in a 30-second time period. The evaluators will control this test telematically by videoconference.
Timepoint [1] 326825 0
days 0, 7 and 14 post-intervention commencement
Primary outcome [2] 326826 0
Multidimensional Dysphnoea-12 (MD12) Spanish version. The MD12 questionnaire will be self-administered and will be performed at the end of the 30STST. Patients will send the results of MD12 screenshot daily to the evaluator, via WhatsApp or email.
Timepoint [2] 326826 0
Days 0, 7, 14 post-intervention commencement
Primary outcome [3] 326827 0
Borg Scale (BS). The Borg scale, of perceived effort, measures the entire range of effort that the individual perceives when exercising. This scale gives criteria to make adjustments to the intensity of exercise, that is, to the workload, and thus forecast and dictate the different intensities of exercise in sports and medical rehabilitation. The BS will be completed by patients at the end of the test,( 30STST). Patients will send the results of BS screenshot to the evaluator, via WhatsApp or email.
Timepoint [3] 326827 0
Days 0, 7 and 14 post-intervention commencement
Secondary outcome [1] 392816 0
Nil
Timepoint [1] 392816 0
Nil

Eligibility
Key inclusion criteria
Patients who are affected by coronavirus (COVID-19), and are in home confinement.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with chronic lung conditions; Patients with chronic kidney disease; Patients affected with chronic neurological disorders; Patients suffering from hypertension and cardiovascular conditions without medical treatment; Patients affected with grade III osteoporosis; Patients affected with acute outbreaks of rheumatologic disorders; Patients affected with acute outbreaks disc abnormalities; Patients who have had respiratory conditions in the last 12 months; Patients who have recent musculoskeletal disorders, and who are not fully recovered from their injuries; Patients who have received physical therapy treatment in the last 3 months; Patients affected with chronic mental and / or psychological disturbances; Red Flags (Night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch)

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)
central randomisation by computer
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 receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/04/2021
Actual
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
21/05/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 23535 0
Spain
State/province [1] 23535 0

Funding & Sponsors
Funding source category [1] 307904 0
Other Collaborative groups
Name [1] 307904 0
Fisiosur i+D
Country [1] 307904 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Avicena S/N Sevilla Spain 41009
Country
Spain
Secondary sponsor category [1] 308618 0
University
Name [1] 308618 0
University of Almeria
Address [1] 308618 0
Calle Universidad de Almería, s/n, 04120 La Cañada, Almería
Country [1] 308618 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307901 0
CEI University Hospital Virgen Rocio-Macarena
Ethics committee address [1] 307901 0
Av. Manuel Siurot, S/n, 41013 Sevilla
Ethics committee country [1] 307901 0
Spain
Date submitted for ethics approval [1] 307901 0
Approval date [1] 307901 0
12/11/2020
Ethics approval number [1] 307901 0
CE2020/2337

Summary
Brief summary
Respiratory exercise can have an important role against respiratory infections and disorders, such as pneumonia and acute respiratory distress syndrome (ARDS), which are two common disorders with COVID-19, and in people in the lockdown period is strongly recommended to decrease risk factors of COVID-19, improving immune and respiratory systems’ function to allow better body response against the disease.

However, traditional rehabilitation has involved human interaction and physical contact, which may lead to an increase in transmission and contagious. To face this problem, telerehabilitation has increased its importance. Indeed, it has been demonstrated that a session of respiratory exercise through a telerehabilitation system is feasible, and it has been proposed as a way of managing with COVID-19.
Therefore, we conducted a randomized controlled trial with the aim of assessing the effectiveness of a program of therapeutic exercise in patients with COVID-19.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108878 0
Dr Cleofas Rodriguez-Blanco
Address 108878 0

University of Seville. Physiotherapy Department
C/ Avicena S/N 41009 Sevilla, Spain
Country 108878 0
Spain
Phone 108878 0
+34619480601
Fax 108878 0
Email 108878 0
cleofas.rguez@gmail.com
Contact person for public queries
Name 108879 0
Dr Cleofas Rodriguez-Blanco
Address 108879 0
University of Seville. Physiotherapy Department
C/ Avicena S/N 41009 Sevilla, Spain
Country 108879 0
Spain
Phone 108879 0
+34619480601
Fax 108879 0
Email 108879 0
cleofas.rguez@gmail.com
Contact person for scientific queries
Name 108880 0
Dr Cleofas Rodriguez-Blanco
Address 108880 0
University of Seville. Physiotherapy Department
C/ Avicena S/N 41009 Sevilla, Spain
Country 108880 0
Spain
Phone 108880 0
+34619480601
Fax 108880 0
Email 108880 0
cleofas.rguez@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Available immediately following publication. No expiration date to share data.
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator (cleofas@us.es)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11003Ethical approval    381455-(Uploaded-12-03-2021-18-28-49)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
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