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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]

None

Universal Trial Number (UTN)

U1111-1266-1496

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COVID-19

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Respiratory

Other respiratory disorders / diseases

Infection

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]

Rehabilitation

Comparator / control treatment

No treatment for control group. Usual care (medical assistance in primary care center)

Control group

Active

Outcomes

Primary outcome [1]

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]

Days 0, 7, 14 post-intervention commencement

Primary outcome [2]

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]

Days 0, 7 and 14. post-intervention commencement

Primary outcome [3]

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]

Days 0, 7 and 14 post-intervention commencement

Secondary outcome [1]

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]

Days 0, 7, 14 post-intervention commencement

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Andalucia

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Fisiosur i+D

Address [1]

Calle Corneta, 1, 04630 Garrucha, Almería

Country [1]

Spain

Primary sponsor type

University

Name

University of Seville

Address

Avicena S/N 41009 Sevilla España

Country

Spain

Secondary sponsor category [1]

University

Name [1]

University of Almeria

Address [1]

Calle Universidad de Almería, s/n, 04120 La Cañada, Almería

Country [1]

Spain

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CEI Universiry Hospital Virgen Rocio-Macarena

Ethics committee address [1]

Av. Manuel Siurot, S/n, 41013 Sevilla

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

Approval date [1]

10/12/2020

Ethics approval number [1]

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

Dr Cleofas Rodriguez-Blanco

Address

University of Seville. Physiotherapy Department
Avizena S/N 41009 Sevilla

Country

Spain

Phone

+34619480601

Fax

[email protected]

Contact person for public queries

Name

Cleofas Rodriguez-Blanco

Address

University of Seville. Physiotherapy Department
Avizena S/N 41009 Sevilla

Country

Spain

Phone

+34619480601

Fax

[email protected]

Contact person for scientific queries

Name

Cleofas Rodriguez-Blanco

Address

University of Seville. Physiotherapy Department
Avizena S/N 41009 Sevilla

Country

Spain

Phone

+34619480601

Fax

[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.	Type	Citation	Link	Email	Other Details	Attachment
11111	Ethical 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

Source	Title	Year of Publication	DOI
Embase	A 14-Day Therapeutic Exercise Telerehabilitation Protocol of Physiotherapy Is Effective in Non-Hospitalized Post-COVID-19 Conditions: A Randomized Controlled Trial.	2023	https://dx.doi.org/10.3390/jcm12030776

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically