Clinical trial NCT04742946: Digital Physiotherapy Practice in Long Covid-19 Patients
Official title: Digital Physiotherapy Practice in Long Covid-19 Patients to Improve Functional Capacity and Quality of Life.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Long COVID-19 Syndrome
Keywords: Digital Physiotherapy Practice (Telerehabilitation)
Covid19 sequelae
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: University of Malaga
First posted: 2021-02-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A quasi-experimental pre-post study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Capacity
timeFrame: Baseline (T0)
measure: Functional Capacity
timeFrame: 4 weeks (T1)
measure: Functional Capacity (SPBB) short performance physical battery test
timeFrame: Baseline (T0)
measure: Functional Capacity (SPBB) short performance physical battery test
timeFrame: Baseline 4 weeks (T1)
measure: The Short Form Health Survey SF-12
timeFrame: Baseline (T0)
measure: The Short Form Health Survey SF-12 Quality of Live
timeFrame: 4 weeks (T1)
measure: European Quality of Life-5 Dimensions EQ-5D
timeFrame: Baseline (T0)
measure: European Quality of Life-5 Dimensions EQ-5D
timeFrame: 4 weeks (T1)
Secondary outcomes:
measure: Telemedicine Satisfaction Questionnaire (TSQ)
timeFrame: 4 weeks (T1)
measure: Cost-effectiveness of the telerehabilitation intervention
timeFrame: 4 weeks T1
measure: Adherence to intervention
timeFrame: 4 weeks T1
measure: Satisfaction and Perception with intervention
timeFrame: 4 weeks T1
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Facultad Ciencias de la Salud
Study officials:
affiliation: Universidad de Granada
name: José-Manuel Pastora-Bernal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.