Long COVID-19 SyndromeTRCovidANCT04742946
Digital Physiotherapy Practice in Long Covid-19 Patients
A study testing Digital Physiotherapy Practice (Telerehabilitation) in people with Long COVID-19 Syndrome, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long COVID-19 Syndrome
- What is being tested?
- Digital Physiotherapy Practice (Telerehabilitation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Cognitive ability not suitable for the use of technological tools
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Long COVID-19 Syndrome
- Being tested
- Digital Physiotherapy Practice (Telerehabilitation)
- Keywords
- Digital Physiotherapy Practice (Telerehabilitation), Covid19 sequelae
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Physiotherapy Practice (Telerehabilitation)Other
Also called Telemedicine, ehealth
Online Physiotherapy services
| Study group | Role | What they receive |
|---|---|---|
| TR Group | Experimental | Personalized digital physiotherapy program 4 weeks. One session per day. Web and mobile application. Auto-Exercise Receives: Other: Digital Physiotherapy Practice (Telerehabilitation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
sit-to-stand test in 1 minute
Measured: Baseline (T0)
Functional Capacity
sit-to-stand test in 1 minute
Measured: 4 weeks (T1)
Functional Capacity (SPBB) short performance physical battery test
(SPBB) short performance physical battery test
Measured: Baseline (T0)
Functional Capacity (SPBB) short performance physical battery test
(SPBB) short performance physical battery test
Measured: Baseline 4 weeks (T1)
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)
Measured: Baseline (T0)
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)
Measured: 4 weeks (T1)
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).
Measured: Baseline (T0)
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).
Measured: 4 weeks (T1)
Secondary outcomes (4)
Telemedicine Satisfaction Questionnaire (TSQ)
Telemedicine Satisfaction Questionnaire (TSQ). Perceived satisfaction comparing telemedicine to inperson in 26 Questions with likert scales
Measured: 4 weeks (T1)
Cost-effectiveness of the telerehabilitation intervention
Direct Costs
Measured: 4 weeks T1
Adherence to intervention
Automatic register by the digital physiotherapy software. Number of treatments and exercise acoording to PT prescription.
Measured: 4 weeks T1
Satisfaction and Perception with intervention
Qualitative interview
Measured: 4 weeks T1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start15 Dec 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Long COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A quasi-experimental pre-post study
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaga
- Responsible party
- Principal investigator, María José Estebanez Pérez, University of Malaga
- Investigators
- José-Manuel Pastora-Bernal, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742946
- Sponsor's protocol ID
- TRCovidAndalucía
- Acronym
- TRCovidA
- Status last verified
- Nov 2022
- First submitted
- 3 Feb 2021
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, Statistical Analysis plan and outcomes measures will be shared
Publications
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.
PubMed 32022836Sohrabi 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.
PubMed 32112977Fu 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.
PubMed 32283155Estebanez-Perez MJ, Martin-Valero R, Pastora-Estebanez P, Pastora-Bernal JM. Experiences of people with Long Covid with a digital physiotherapy intervention: A qualitative study. Health Expect. 2024 Apr;27(2):e13993. doi: 10.1111/hex.13993.
PubMed 38590093Estebanez-Perez MJ, Pastora-Bernal JM, Vinolo-Gil MJ, Pastora-Estebanez P, Martin-Valero R. Digital physiotherapy is a satisfactory and effective method to improve the quality of life in Long COVID patients. Digit Health. 2024 Feb 26;10:20552076241234432. doi: 10.1177/20552076241234432. eCollection 2024 Jan-Dec.
PubMed 38414563Estebanez-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.
PubMed 35954922Pastora-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.
PubMed 33809277
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Physiotherapy Practice in Long Covid-19 Patients to Improve Functional Capacity and Quality of Life.
- ClinicalTrials.gov ID
- NCT04742946
- Acronym / sponsor ID
- TRCovidA / TRCovidAndalucía
- Conditions
- Long COVID-19 Syndrome
- Keywords
- Digital Physiotherapy Practice (Telerehabilitation), Covid19 sequelae
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University of Malaga
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A quasi-experimental pre-post study
| Arm | Type | Receives |
|---|---|---|
| TR Group | Experimental | Other: Digital Physiotherapy Practice (Telerehabilitation)Personalized digital physiotherapy program 4 weeks. One session per day. Web and mobile application. Auto-Exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -Cognitive ability not suitable for the use of technological tools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Physiotherapy Practice (Telerehabilitation)Also: Telemedicine, ehealthOnline Physiotherapy services | Other | TR Group |
Primary outcome
Functional Capacity
Time frame: Baseline (T0)
sit-to-stand test in 1 minute
Functional Capacity
Time frame: 4 weeks (T1)
sit-to-stand test in 1 minute
Functional Capacity (SPBB) short performance physical battery test
Time frame: Baseline (T0)
(SPBB) short performance physical battery test
Functional Capacity (SPBB) short performance physical battery test
Time frame: Baseline 4 weeks (T1)
(SPBB) short performance physical battery test
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)
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)
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).
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 secondary outcomes
Telemedicine Satisfaction Questionnaire (TSQ)
Time frame: 4 weeks (T1)
Cost-effectiveness of the telerehabilitation intervention
Time frame: 4 weeks T1
Adherence to intervention
Time frame: 4 weeks T1
Satisfaction and Perception with intervention
Time frame: 4 weeks T1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Results publication: PubMed 32022836Del 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 publication: PubMed 32112977Sohrabi 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.
- Results publication: PubMed 32283155Fu 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.
- Derived from this study: PubMed 38590093Estebanez-Perez MJ, Martin-Valero R, Pastora-Estebanez P, Pastora-Bernal JM. Experiences of people with Long Covid with a digital physiotherapy intervention: A qualitative study. Health Expect. 2024 Apr;27(2):e13993. doi: 10.1111/hex.13993.
- Derived from this study: PubMed 38414563Estebanez-Perez MJ, Pastora-Bernal JM, Vinolo-Gil MJ, Pastora-Estebanez P, Martin-Valero R. Digital physiotherapy is a satisfactory and effective method to improve the quality of life in Long COVID patients. Digit Health. 2024 Feb 26;10:20552076241234432. doi: 10.1177/20552076241234432. eCollection 2024 Jan-Dec.
- Derived from this study: PubMed 35954922Estebanez-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.
- Derived from this study: PubMed 33809277Pastora-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.
- Individual participant dataSharing planned: Yes. Study protocol, Statistical Analysis plan and outcomes measures will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José-Manuel Pastora-Bernal, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Physiotherapy Practice (Telerehabilitation) in people with Long COVID-19 Syndrome, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (time frame: Baseline (T0)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04742946, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.