Digital Physiotherapy Practice in Long Covid-19 Patients

NCT04742946 | Unknown

• 1 other identifier: TRCovidAndalucía
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID-19 Syndrome

Keywords

Digital Physiotherapy Practice (Telerehabilitation); Covid19 sequelae

Outcome Measures

Primary Outcomes (8)

• Functional Capacity

  sit-to-stand test in 1 minute

  Baseline (T0)

• Functional Capacity

  sit-to-stand test in 1 minute

  4 weeks (T1)

• Functional Capacity (SPBB) short performance physical battery test

  (SPBB) short performance physical battery test

  Baseline (T0)

• Functional Capacity (SPBB) short performance physical battery test

  (SPBB) short performance physical battery test

  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)

  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)

  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).

  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).

  4 weeks (T1)

Secondary Outcomes (4)

• Telemedicine Satisfaction Questionnaire (TSQ)

  4 weeks (T1)

• Cost-effectiveness of the telerehabilitation intervention

  4 weeks T1

• Adherence to intervention

  4 weeks T1

• Satisfaction and Perception with intervention

  4 weeks T1

Study Arms (1)

TR Group

EXPERIMENTAL

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

Other: Digital Physiotherapy Practice (Telerehabilitation)

Interventions

Digital Physiotherapy Practice (Telerehabilitation) OTHER

Online Physiotherapy services

Also known as: Telemedicine, ehealth

TR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive ability not suitable for the use of technological tools

Sponsors & Collaborators

• Universidad de Granada: lead
• University of Malaga: collaborator

Study Sites (1)

Facultad Ciencias de la Salud

Málaga, 29004, Spain

Location

Related Publications (7)

• 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.

  PMID: 32022836 RESULT

• 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.

  PMID: 32112977 RESULT

• 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.

  PMID: 32283155 RESULT

• Estebanez-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.

  PMID: 38590093 DERIVED

• Estebanez-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.

  PMID: 38414563 DERIVED

• 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.

  PMID: 35954922 DERIVED

• 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.

  PMID: 33809277 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Telerehabilitation; Telemedicine

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• José-Manuel Pastora-Bernal, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. PhD

Model Details: A quasi-experimental pre-post study

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: December 15, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 8 weeks
• Access Criteria: data will be shared upon request to the principal investigator

Locations

ES (1)