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Digital Physiotherapy Practice in Long Covid-19 Patients (TRCovidA)

Primary Purpose

Long COVID-19 Syndrome

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Digital Physiotherapy Practice (Telerehabilitation)
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long COVID-19 Syndrome focused on measuring Digital Physiotherapy Practice (Telerehabilitation), Covid19 sequelae

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult over 18 years old
  • Diagnosis: Long COVID-19 syndrome
  • Residing in the Andalusian Community during the research period
  • To have a computer technology with an internet connection aat home (personal computer, laptop, tablet or smartphone)
  • Ability and knowledge to access email or whatsapp

Exclusion Criteria:

-Cognitive ability not suitable for the use of technological tools

Sites / Locations

  • Facultad Ciencias de la Salud

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TR Group

Arm Description

Personalized digital physiotherapy program 4 weeks. One session per day. Web and mobile application. Auto-Exercise

Outcomes

Primary Outcome Measures

Functional Capacity
sit-to-stand test in 1 minute
Functional Capacity
sit-to-stand test in 1 minute
Functional Capacity (SPBB) short performance physical battery test
(SPBB) short performance physical battery test
Functional Capacity (SPBB) short performance physical battery test
(SPBB) short performance physical battery test
The Short Form Health Survey SF-12
Quality of Live. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension). a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status). 100 (the best health status)
The Short Form Health Survey SF-12 Quality of Live
The SF-12 For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension). a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status). 100 (the best health status)
European Quality of Life-5 Dimensions EQ-5D
Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).
European Quality of Life-5 Dimensions EQ-5D
Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).

Secondary Outcome Measures

Telemedicine Satisfaction Questionnaire (TSQ)
Telemedicine Satisfaction Questionnaire (TSQ). Perceived satisfaction comparing telemedicine to inperson in 26 Questions with likert scales
Cost-effectiveness of the telerehabilitation intervention
Direct Costs
Adherence to intervention
Automatic register by the digital physiotherapy software. Number of treatments and exercise acoording to PT prescription.
Satisfaction and Perception with intervention
Qualitative interview

Full Information

First Posted
February 3, 2021
Last Updated
November 14, 2022
Sponsor
Universidad de Granada
Collaborators
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT04742946
Brief Title
Digital Physiotherapy Practice in Long Covid-19 Patients
Acronym
TRCovidA
Official Title
Digital Physiotherapy Practice in Long Covid-19 Patients to Improve Functional Capacity and Quality of Life.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
Collaborators
University of Malaga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The COVID-19 can cause important sequels in the respiratory system by bilateral pneumonia and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Long COVID-19 has been defined as the condition occurring in individuals with a history of probable or confirmed SARS-CoV-2 infection, with related symptoms lasting at least 2 months and not explainable by an alternative diagnosis. The practice of digital physiotherapy presents itself as a promising complementary treatment method to standard physiotherapy, playing a key role in the recovery of function in subjects who have passed the disease and who maintain some symptomatology over time. The aims of this research are to explore the effect of a digital physiotherapy intervention on functional recovery in patients diagnosed with Long COVID-19 and to identify the level of adherence to the treatment carried out. Physiotherapy interventions acquires a fundamental role in the recovery of the functions and the quality of life. As secondary objectives, the aim is to identify the satisfaction and perception of patients with the intervention and the presence of barriers to its implementation (throught a qualitative research), as well as to evaluate the cost-effectiveness from the perspective of the health system. A quasi-experimental pre-post study assessed initially and at the end of the 4-week intervention the functional capacity (1-min STS and SPPB) and the adherence (software). The hypothesis of this research is that the implementation of a TR program presents positive results. If hypothesis is confirmed, that would be an opportunity to define new policies and interventions to address this disease and its consequences.
Detailed Description
The authors hypothesised that the implementation of a digital physiotherapy intervention in Long COVID-19 participants is effective to improve the functional capacity and adherence and have positive results in patients satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID-19 Syndrome
Keywords
Digital Physiotherapy Practice (Telerehabilitation), Covid19 sequelae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A quasi-experimental pre-post study
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TR Group
Arm Type
Experimental
Arm Description
Personalized digital physiotherapy program 4 weeks. One session per day. Web and mobile application. Auto-Exercise
Intervention Type
Other
Intervention Name(s)
Digital Physiotherapy Practice (Telerehabilitation)
Other Intervention Name(s)
Telemedicine, ehealth
Intervention Description
Online Physiotherapy services
Primary Outcome Measure Information:
Title
Functional Capacity
Description
sit-to-stand test in 1 minute
Time Frame
Baseline (T0)
Title
Functional Capacity
Description
sit-to-stand test in 1 minute
Time Frame
4 weeks (T1)
Title
Functional Capacity (SPBB) short performance physical battery test
Description
(SPBB) short performance physical battery test
Time Frame
Baseline (T0)
Title
Functional Capacity (SPBB) short performance physical battery test
Description
(SPBB) short performance physical battery test
Time Frame
Baseline 4 weeks (T1)
Title
The Short Form Health Survey SF-12
Description
Quality of Live. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension). a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status). 100 (the best health status)
Time Frame
Baseline (T0)
Title
The Short Form Health Survey SF-12 Quality of Live
Description
The SF-12 For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 0 (the worst health status for that dimension). a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status). 100 (the best health status)
Time Frame
4 weeks (T1)
Title
European Quality of Life-5 Dimensions EQ-5D
Description
Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).
Time Frame
Baseline (T0)
Title
European Quality of Life-5 Dimensions EQ-5D
Description
Quality of Live The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. The collection of index values for all possible EQ-5D states is called a value set. Value sets are currently available for the EQ-5D-3L and EQ-5D-5L for different countries/regions. Several valuation techniques have been used to generate these value sets: time trade-off (TTO), visual analogue scale (VAS), and more recently, discrete choice experiments (DCE).
Time Frame
4 weeks (T1)
Secondary Outcome Measure Information:
Title
Telemedicine Satisfaction Questionnaire (TSQ)
Description
Telemedicine Satisfaction Questionnaire (TSQ). Perceived satisfaction comparing telemedicine to inperson in 26 Questions with likert scales
Time Frame
4 weeks (T1)
Title
Cost-effectiveness of the telerehabilitation intervention
Description
Direct Costs
Time Frame
4 weeks T1
Title
Adherence to intervention
Description
Automatic register by the digital physiotherapy software. Number of treatments and exercise acoording to PT prescription.
Time Frame
4 weeks T1
Title
Satisfaction and Perception with intervention
Description
Qualitative interview
Time Frame
4 weeks T1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult over 18 years old Diagnosis: Long COVID-19 syndrome Residing in the Andalusian Community during the research period To have a computer technology with an internet connection aat home (personal computer, laptop, tablet or smartphone) Ability and knowledge to access email or whatsapp Exclusion Criteria: -Cognitive ability not suitable for the use of technological tools
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José-Manuel Pastora-Bernal, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad Ciencias de la Salud
City
Málaga
ZIP/Postal Code
29004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol, Statistical Analysis plan and outcomes measures will be shared
IPD Sharing Time Frame
8 weeks
IPD Sharing Access Criteria
data will be shared upon request to the principal investigator
Citations:
PubMed Identifier
32022836
Citation
Del Rio C, Malani PN. 2019 Novel Coronavirus-Important Information for Clinicians. JAMA. 2020 Mar 17;323(11):1039-1040. doi: 10.1001/jama.2020.1490. No abstract available.
Results Reference
result
PubMed Identifier
32112977
Citation
Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, Iosifidis C, Agha R. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). Int J Surg. 2020 Apr;76:71-76. doi: 10.1016/j.ijsu.2020.02.034. Epub 2020 Feb 26. Erratum In: Int J Surg. 2020 May;77:217.
Results Reference
result
PubMed Identifier
32283155
Citation
Fu L, Wang B, Yuan T, Chen X, Ao Y, Fitzpatrick T, Li P, Zhou Y, Lin YF, Duan Q, Luo G, Fan S, Lu Y, Feng A, Zhan Y, Liang B, Cai W, Zhang L, Du X, Li L, Shu Y, Zou H. Clinical characteristics of coronavirus disease 2019 (COVID-19) in China: A systematic review and meta-analysis. J Infect. 2020 Jun;80(6):656-665. doi: 10.1016/j.jinf.2020.03.041. Epub 2020 Apr 10.
Results Reference
result
PubMed Identifier
35954922
Citation
Estebanez-Perez MJ, Pastora-Bernal JM, Martin-Valero R. The Effectiveness of a Four-Week Digital Physiotherapy Intervention to Improve Functional Capacity and Adherence to Intervention in Patients with Long COVID-19. Int J Environ Res Public Health. 2022 Aug 3;19(15):9566. doi: 10.3390/ijerph19159566.
Results Reference
derived
PubMed Identifier
33809277
Citation
Pastora-Bernal JM, Estebanez-Perez MJ, Molina-Torres G, Garcia-Lopez FJ, Sobrino-Sanchez R, Martin-Valero R. Telerehabilitation Intervention in Patients with COVID-19 after Hospital Discharge to Improve Functional Capacity and Quality of Life. Study Protocol for a Multicenter Randomized Clinical Trial. Int J Environ Res Public Health. 2021 Mar 12;18(6):2924. doi: 10.3390/ijerph18062924.
Results Reference
derived

Learn more about this trial

Digital Physiotherapy Practice in Long Covid-19 Patients

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