Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000347864
Ethics application status
Approved
Date submitted
21/03/2021
Date registered
26/03/2021
Date last updated
26/03/2021
Date data sharing statement initially provided
26/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a telerehabilitation program for therapeutic toning and respiratory exercises in patients affected by Covid-19 sequelae
Scientific title
Efficacy of a telerehabilitation program for therapeutic toning and respiratory exercises on mobility and level of exertion in patients affected by Covid-19 sequelae
Secondary ID [1] 303700 0
None
Universal Trial Number (UTN)
U1111-1266-1496
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 321119 0
Condition category
Condition code
Musculoskeletal 318913 318913 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 318991 318991 0 0
Physiotherapy
Respiratory 318992 318992 0 0
Other respiratory disorders / diseases
Infection 318993 318993 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Exercise Program consisted of 10 exercises based on with scientific evidence, respiratory exercises based on 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. Non-specific toning exercises of resistance and strength to try to improve the physical deconditioning and physiological deterioration that implies. The exercises are available at https://www.fisiosurid.com/ejercicios-tonificacion-respiratoria/ , 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] 320003 0
Rehabilitation
Comparator / control treatment
No treatment for control group. Usual care (medical assistance in primary care center)
Control group
Active

Outcomes
Primary outcome [1] 326851 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] 326851 0
Days 0, 7, 14 post-intervention commencement
Primary outcome [2] 326852 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 [2] 326852 0
Days 0, 7 and 14. post-intervention commencement
Primary outcome [3] 326853 0
Six-Minute Walk Test (6MWT). The 6MWT will be performed by all patients in their home, under the telematically supervision of a physiotherapist. All patients will receive the same instructions before the walk and will be encouraged by the physiotherapist who repeated set phrases every minute during the walk. The distance covered during the test will be recorded in meters telematically by the patient’s smartphone. Patients will be allowed to stop and rest during the test, but they will be instructed to resume walking as soon as they felt able to do so.
Timepoint [3] 326853 0
Days 0, 7 and 14 post-intervention commencement
Secondary outcome [1] 392886 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 to the evaluator, via WhatsApp or email.
Timepoint [1] 392886 0
Days 0, 7, 14 post-intervention commencement
Secondary outcome [2] 392887 0
Visual Analog Scale Fatigue (VASF), for fatigue measurement. Patients participating in the study will indicate the intensity of their fatigue by means of the VAS through the smartphone application called “Visual Scale” (Apple Store and Google Play). They will have to signal in a horizontal line where they would place their fatigue, being 0 “no fatigue” and the 10 would be “the worst imaginable fatigue”. VASF will be controlled telematically by the evaluators through the Smartphone application. The evaluator will ask the patient to indicate their level of VASF in the “Visual Scale” application and to take a screenshot of the smartphone to obtain the established value for VASF, which is calculated as the average value of two attempts.
Timepoint [2] 392887 0
Days 0, 7, 14 post-intervention commencement

Eligibility
Key inclusion criteria
Patients with COVID-19 positive polymerase chain reaction (PCR) test and/or Antygen-test more than 40 days ago.

Physical sequelae related to deconditioning and fatigue
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, chronic kidney disease, chronic neurological disorders. Patients suffering from hypertension and cardiovascular conditions without medical treatment. Patients affected with grade III osteoporosis, with acute phase of rheumatologic disorders, with acute phase of disc abnormalities.

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
15/05/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 23537 0
Spain
State/province [1] 23537 0
Andalucia

Funding & Sponsors
Funding source category [1] 308115 0
Other Collaborative groups
Name [1] 308115 0
Fisiosur i+D
Country [1] 308115 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Avicena S/N 41009 Sevilla España
Country
Spain
Secondary sponsor category [1] 308869 0
University
Name [1] 308869 0
University of Almeria
Address [1] 308869 0
Calle Universidad de Almería, s/n, 04120 La Cañada, Almería
Country [1] 308869 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308101 0
CEI Universiry Hospital Virgen Rocio-Macarena
Ethics committee address [1] 308101 0
Av. Manuel Siurot, S/n, 41013 Sevilla
Ethics committee country [1] 308101 0
Spain
Date submitted for ethics approval [1] 308101 0
Approval date [1] 308101 0
10/12/2020
Ethics approval number [1] 308101 0
CE2020/3643

Summary
Brief summary
This trial designed to analyze the results in terms of the level of fatigue and perceived exertion, physical health, and maintenance of respiratory activity of exercise program based on toning and respiratory, applied in patients affected by COVID-19 sequeale. We intend to investigate a field not previously studied: the repercussion of carrying out a toning and respiratory exercise program in these patients, we consider that this study could be of interest in public health, Trying to alleviate the sequelae in relation to physical deconditioning and loss of musculoskeletal capacity should be a priority.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109538 0
Dr Cleofas Rodriguez-Blanco
Address 109538 0
University of Seville. Physiotherapy Department
Avizena S/N 41009 Sevilla
Country 109538 0
Spain
Phone 109538 0
+34619480601
Fax 109538 0
Email 109538 0
[email protected]
Contact person for public queries
Name 109539 0
Dr Cleofas Rodriguez-Blanco
Address 109539 0
University of Seville. Physiotherapy Department
Avizena S/N 41009 Sevilla
Country 109539 0
Spain
Phone 109539 0
+34619480601
Fax 109539 0
Email 109539 0
[email protected]
Contact person for scientific queries
Name 109540 0
Dr Cleofas Rodriguez-Blanco
Address 109540 0
University of Seville. Physiotherapy Department
Avizena S/N 41009 Sevilla
Country 109540 0
Spain
Phone 109540 0
+34619480601
Fax 109540 0
Email 109540 0
[email protected]

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 ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11111Ethical approval    381620-(Uploaded-21-03-2021-22-25-33)-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
SourceTitleYear of PublicationDOI
EmbaseA 14-Day Therapeutic Exercise Telerehabilitation Protocol of Physiotherapy Is Effective in Non-Hospitalized Post-COVID-19 Conditions: A Randomized Controlled Trial.2023https://dx.doi.org/10.3390/jcm12030776
N.B. These documents automatically identified may not have been verified by the study sponsor.