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

November 14, 2022 updated by: María José Estebanez Pérez, Universidad de Granada

Digital Physiotherapy Practice in Long Covid-19 Patients to Improve Functional Capacity and Quality of Life.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain, 29004
        • Facultad Ciencias de la Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TR Group
Personalized digital physiotherapy program 4 weeks. One session per day. Web and mobile application. Auto-Exercise
Other: Digital Physiotherapy Practice (Telerehabilitation)
Online Physiotherapy services
Other Names:
  • Telemedicine, ehealth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Capacity
Time Frame: Baseline (T0)
sit-to-stand test in 1 minute
Baseline (T0)
Functional Capacity
Time Frame: 4 weeks (T1)
sit-to-stand test in 1 minute
4 weeks (T1)
Functional Capacity (SPBB) short performance physical battery test
Time Frame: Baseline (T0)
(SPBB) short performance physical battery test
Baseline (T0)
Functional Capacity (SPBB) short performance physical battery test
Time Frame: Baseline 4 weeks (T1)
(SPBB) short performance physical battery test
Baseline 4 weeks (T1)
The Short Form Health Survey SF-12
Time Frame: Baseline (T0)

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)
Baseline (T0)
The Short Form Health Survey SF-12 Quality of Live
Time Frame: 4 weeks (T1)

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)
4 weeks (T1)
European Quality of Life-5 Dimensions EQ-5D
Time Frame: Baseline (T0)
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).
Baseline (T0)
European Quality of Life-5 Dimensions EQ-5D
Time Frame: 4 weeks (T1)
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).
4 weeks (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telemedicine Satisfaction Questionnaire (TSQ)
Time Frame: 4 weeks (T1)
Telemedicine Satisfaction Questionnaire (TSQ). Perceived satisfaction comparing telemedicine to inperson in 26 Questions with likert scales
4 weeks (T1)
Cost-effectiveness of the telerehabilitation intervention
Time Frame: 4 weeks T1
Direct Costs
4 weeks T1
Adherence to intervention
Time Frame: 4 weeks T1
Automatic register by the digital physiotherapy software. Number of treatments and exercise acoording to PT prescription.
4 weeks T1
Satisfaction and Perception with intervention
Time Frame: 4 weeks T1
Qualitative interview
4 weeks T1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Collaborators

University of Malaga

Investigators

  • Principal Investigator: José-Manuel Pastora-Bernal, PhD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2021

Primary Completion (ANTICIPATED)

December 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (ACTUAL)

February 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRCovidAndalucía

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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