NCT04895371

Brief Summary

Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), is a multisystem infectious disease which has led to a global pandemic. Tele-medicine is a tool to connect patients and health care professions while maintaining social distancing and restrictions. Tele-physiotherapy is a field of physiotherapy which has the advantage of providing therapy. Since some months ago, different organizations have started the tele-physiotherapy/tele-rehabilitation program to manage the patients' complications after COVID-19. This research team have developed a tele-rehabilitation guideline for physiotherapists to help them how to use tele-physiotherapy program for patients after COVID-19 hospitalization. The aim of this study is to evaluate the efficacy of tele-physiotherapy program in patients discharged after COVID-19.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

June 12, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 3, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

May 15, 2021

Last Update Submit

May 31, 2022

Conditions

Covid19Coronavirus Disease 2019

Outcome Measures

Primary Outcomes (3)

  • 6-Minute Walk Test (6MWT)

    6-minute walk test is a sub-maximal test to evaluate the aerobic capacity. The distance which patient can walk during 6 minutes will be measured.

    Baseline

  • 6-Minute Walk Test (6MWT)

    6-minute walk test is a sub-maximal test to evaluate the aerobic capacity. The distance which patient can walk during 6 minutes will be measured.

    After six weeks

  • 6-Minute Walk Test (6MWT)

    6-minute walk test is a sub-maximal test to evaluate the aerobic capacity. The distance which patient can walk during 6 minutes will be measured.

    After 10 weeks

Secondary Outcomes (27)

  • Five Times Sit to Stand test (5TST)

    Baseline

  • Five Times Sit to Stand test (5TST)

    After six weeks

  • Five Times Sit to Stand test (5TST)

    After 10 weeks

  • Fatigue Severity Scale (FSS)

    Baseline

  • Fatigue Severity Scale (FSS)

    After six weeks

  • +22 more secondary outcomes

Study Arms (2)

Tele-physiotherapy group

EXPERIMENTAL

Allocated participants to this group will receive 18 physiotherapy sessions (three sessions per week) during six weeks. in these sessions, physiotherapist will prescribe aerobic, resistive, breathing and functional exercises and airway clearance techniques (if needed) based on result of assessment of patients at the discharge phase. the physiotherapist will use some educational contents for the patient and call him/her to guide the patient about how exercises should be performed (determining frequency, time, intensity and type of exercise). the patient should do exercises until next session and provide a feedback. The patient will be assessed weekly using a pre-designed questionnaire remotely. the progression of interventions will be based on the results of weekly assessment.

Other: Tele-physiotherapy group

Control group

ACTIVE COMPARATOR

Allocated participants to control group will receive one consultation session by the physiotherapist. At this session, patients will be educated about how to perform their daily activities, breathing exercises, walking, using oxygen cylinder and dietary.

Other: Control group

Interventions

Tele-physiotherapy groupOTHER

Allocated participants to this group will receive 18 physiotherapy sessions (three sessions per week) during six weeks. in these sessions, physiotherapist will prescribe aerobic, resistive, breathing and functional exercises and airway clearance techniques (if needed) based on result of assessment of patients at the discharge phase. the physiotherapist will use some educational contents for the patient and call him/her to guide the patient about how exercises should be performed (determining frequency, time, intensity and type of exercise). the patient should do exercises until next session and provide a feedback. The patient will be assessed weekly using a pre-designed questionnaire remotely. the progression of interventions will be based on the results of weekly assessment.

Tele-physiotherapy group
Control groupOTHER

Allocated participants to control group will receive one consultation session by the physiotherapist. At this session, patients will be educated about how to perform their daily activities, breathing exercises, walking, using oxygen cylinder and dietary.

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Discharged patients with Covid-19 pneumonia,
  • Having at least one rT-PCR Covid test,
  • Duration of hospitalization \> 10 days,
  • Ability to walk,
  • Totally oriented,
  • Ability to use smartphone,
  • Ability to read and write in Persian.

You may not qualify if:

  • Having any kind of musculoskeletal disorder causing inability to participate in physiotherapy sessions,
  • Severe cardiovascular impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Khomeini Hospital Complex

Tehran, Iran

Location

Related Publications (17)

  • Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.

    PMID: 12890299BACKGROUND

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PMID: 12900694BACKGROUND

  • Vasheghani-Farahani A, Tahmasbi M, Asheri H, Ashraf H, Nedjat S, Kordi R. The Persian, last 7-day, long form of the International Physical Activity Questionnaire: translation and validation study. Asian J Sports Med. 2011 Jun;2(2):106-16. doi: 10.5812/asjsm.34781.

    PMID: 22375226BACKGROUND

  • Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.

    PMID: 7624188BACKGROUND

  • Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

    PMID: 2803071BACKGROUND

  • Azimian M, Farahani AS, Dadkhah A, Fallahpour M, Karimlu M. Fatigue severity scale: the psychometric properties of the persian-version in patients with multiple sclerosis. Res J Biol Sci. 2009;4(9):974-7.

    BACKGROUND

  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PMID: 1593914BACKGROUND

  • Montazeri A, Goshtasebi A, Vahdaninia M, Gandek B. The Short Form Health Survey (SF-36): translation and validation study of the Iranian version. Qual Life Res. 2005 Apr;14(3):875-82. doi: 10.1007/s11136-004-1014-5.

    PMID: 16022079BACKGROUND

  • Thomas P, Baldwin C, Bissett B, Boden I, Gosselink R, Granger CL, Hodgson C, Jones AY, Kho ME, Moses R, Ntoumenopoulos G, Parry SM, Patman S, van der Lee L. Physiotherapy management for COVID-19 in the acute hospital setting: clinical practice recommendations. J Physiother. 2020 Apr;66(2):73-82. doi: 10.1016/j.jphys.2020.03.011. Epub 2020 Mar 30.

    PMID: 32312646BACKGROUND

  • World Health Organization. COVID-19 clinical management: living guidance, 25 January 2021. World Health Organization; 2021.

    BACKGROUND

  • SeyedAlinaghi S, Afsahi AM, MohsseniPour M, Behnezhad F, Salehi MA, Barzegary A, Mirzapour P, Mehraeen E, Dadras O. Late Complications of COVID-19; a Systematic Review of Current Evidence. Arch Acad Emerg Med. 2021 Jan 20;9(1):e14. doi: 10.22037/aaem.v9i1.1058. eCollection 2021. No abstract available.

    PMID: 33681819BACKGROUND

  • Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

    PMID: 31978945BACKGROUND

  • Portnoy J, Waller M, Elliott T. Telemedicine in the Era of COVID-19. J Allergy Clin Immunol Pract. 2020 May;8(5):1489-1491. doi: 10.1016/j.jaip.2020.03.008. Epub 2020 Mar 24. No abstract available.

    PMID: 32220575BACKGROUND

  • Salawu A, Green A, Crooks MG, Brixey N, Ross DH, Sivan M. A Proposal for Multidisciplinary Tele-Rehabilitation in the Assessment and Rehabilitation of COVID-19 Survivors. Int J Environ Res Public Health. 2020 Jul 7;17(13):4890. doi: 10.3390/ijerph17134890.

    PMID: 32645876BACKGROUND

  • Cortes-Telles A, Lopez-Romero S, Figueroa-Hurtado E, Pou-Aguilar YN, Wong AW, Milne KM, Ryerson CJ, Guenette JA. Pulmonary function and functional capacity in COVID-19 survivors with persistent dyspnoea. Respir Physiol Neurobiol. 2021 Jun;288:103644. doi: 10.1016/j.resp.2021.103644. Epub 2021 Feb 27.

    PMID: 33647535RESULT

  • Jenkins SC. 6-Minute walk test in patients with COPD: clinical applications in pulmonary rehabilitation. Physiotherapy. 2007 Sep 1;93(3):175-82.

    RESULT

  • Javaherian M, Shadmehr A, Keshtkar A, Beigmohammadi MT, Dabbaghipour N, Syed A, Attarbashi Moghadam B. Safety and efficacy of pulmonary physiotherapy in hospitalized patients with severe COVID-19 pneumonia (PPTCOVID study): A prospective, randomised, single-blind, controlled trial. PLoS One. 2023 Jan 31;18(1):e0268428. doi: 10.1371/journal.pone.0268428. eCollection 2023.

    PMID: 36719885RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Mohammad Javaherian, Ph.D. cand.

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Mohsen Nasiri-toosi, MD.

    Tehran University of Medical Sciences

    STUDY DIRECTOR

  • Behrouz Attarbashi Moghadam, Ph.D.

    Tehran University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor will be blinded to the randomization and allocation. The assessor will have not access to patients' medical record. Patients will be also asked to do not explain about their procedure to the assessor.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The participants will be randomly allocated to Tele-physiotherapy or control groups. The sample size was calculated to identify clinically relevant effects on the primary outcome, the distance of six-minute walk test. The calculation was performed using STATA 16 software. Presuming a two-sided significance level (α) of 0.05, the power of 80% (β=0.20) and standard deviation based on the results of a relevant study in COVID-19 survivors which assessed the distance of six-minute walk test. Minimal clinically important difference (MCID) of 54m was reported and considered to be clinically significant. Repeated measurement of ANCOVA was used for the calculation with a baseline and two follow-up measurements (correlation of repeated measurement=0.499). After considering 20% possible participants attrition, It was determined that a sample size of 72 participants would be required to detect a significant change, 36 in each group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Liver Transplantation Research Center

Study Record Dates

First Submitted

May 15, 2021

First Posted

May 20, 2021

Study Start

June 12, 2021

Primary Completion

November 20, 2021

Study Completion

April 30, 2022

Last Updated

June 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

All related mentioned data will be available through the principle investigator (Email: Javaherian\_m@razi.tums.ac.ir) for researchers who provide a related approved proposal and ethical committee approve to achieve aims. These data will be available with publication date until one year.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Until one year after result publication.
Access Criteria
All researchers who provide a related approved proposal and ethical committee approve to achieve aims.

Locations

IR(1)