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Vol. 57. Issue 3.
Pages 195-204 (March 2021)
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Vol. 57. Issue 3.
Pages 195-204 (March 2021)
Original Article
DOI: 10.1016/j.arbr.2020.03.029
Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial
Programa de telerrehabilitación como estrategia de mantenimiento para pacientes con EPOC: un ensayo clínico aleatorizado de 12 meses
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Juan B. Galdiza,
Corresponding author
med001901@hotmail.com

Corresponding author.
, Alba Gómezb, Diego Rodriguezc, Rosa Guelld, Pilar Cebolleroe, Javier Huetoe, Pilar Cejudof, Francisco Ortegag, Itxaso Sayagoh, Susana Chici, Marta Iscarj, Carlos Amadok, Gemma Rodríguez Trigol, Borja G. Cosiom, Victor Bustamanten, Josèc) Ignacio Pijoano
a Respiratory Department, Hospital Universitario Cruces, Osakidetza, Biocruces Bizkaia Health Research Institute, CibeRes, Barakaldo, Spain
b Unitat Rehabilitació Cardio-Respiratoria, Hospital Universitari Vall d
tm)Hebron, Barcelona, Spain
c Respiratory Department, Hospital del Mar, CibeRes, Barcelona, Spain
d Respiratory Department, Hospital de la Santa Creu i San Pau, CibeRes, Barcelona, Spain
e Respiratory Department, Complejo Hospitalario Navarra, Pamplona, Spain
f Instituto de Biomedicina de Sevilla, Unidad Mèc)dico-Quirúrgica de Enfermedades Respiratorias, Hospital Virgen Rocío, Sevilla, Spain
g Instituto de Biomedicina de Sevilla, Unidad Mèc)dico-Quirúrgica de Enfermedades Respiratorias, Hospital Virgen Rocio, CibeRes, Sevilla, Spain
h Respiratory Department, Clínica Asunción, Tolosa, Gipuzkoa, Spain
i Internal Medicine Department (Respiratory Unit), Hospital de Mendaro, Osakidetza, Mendaro, Gipuzkoa, Spain
j Respiratory Department, Hospital General de Asturias, Oviedo, Spain
k Respiratory Department, Hospital Universitario Marquèc)s de Valdecilla, Santander, Spain
l Respiratory Department, Hospital Álvaro Cunqueiro, Vigo, Spain
m Respiratory Department, Hospital Universitary Son Espases, Palma de Mallorca, CibeRes, Spain
n Respiratory Department, Hospital Universitario Basurto, Bilbao, Spain
o Clinical Epidemiology Unit, Hospital Universitario de Cruces, Biocruces Bizkaia, Health Research Institute, Bilbao, Spain
Article information
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Tables (7)
Table 1. Characteristics of Patients at Enrolment and Randomization Visits.
Table 2. Descriptive Data for Outcome Variables at Randomization (Visit 0) and Follow-up Visits.
Table 3. Longitudinal Linear Analysis of Measures at 3, 9 and 12 Months, Adjusting for Values at Randomization Visit.
Table 4. Number of Patients Who Attended Follow-up Appointments by Group.
Table 5. Number of Exacerbations per Period Between Visits.
Table 6. Change Over Time in the 6-Minute Walk Test Distance in Each Group Stratified by the Presence of at Least One Exacerbation Episode.
Table 7. Joint Effect of Several Variables on 6MWT Distance Walked at 12 Month Visit.
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Additional material (1)
Abstract
Background

There is uncertainty regarding efficacy of telehealth-based approaches in COPD patients for sustaining benefits achieved with intensive pulmonary rehabilitation (PR).

Research question

To determine whether a maintenance pulmonary telerehabilitation (TelePR) programme, after intensive initial PR, is superior to usual care in sustaining over time benefits achieved by intensive PR.

Study design and methods

A multicentre open-label pragmatic parallel-group randomized clinical trial was conducted. Two groups were created at completion of an 8-week intensive outpatient hospital PR programme. Intervention group (IG) patients were given appropriate training equipment and instructed to perform three weekly training sessions and send performance data through an app to a web-based platform. Patients in the control group (CG) were advised to exercise regularly (usual care).

Results

Ninety-four patients (46 IG, 48 CG) were randomized. The analysis of covariance showed non-significant improvements in 6-min walk distance [19.9m (95% CI ∧4.1/+43.8)] and Chronic Respiratory Disease Questionnaire • Emotion score [0.4 points (0•0.8)] in the IG. Secondary linear mixed models showed improvements in the IG in Short Form-36 mental component summary [9.7, (4.0•15.4)] and Chronic Respiratory Disease Questionnaire • Emotion [0.5, (0.2•0.9)] scores, but there was no association between compliance and outcomes. Acute exacerbations were associated with a marginally significant decrease in 6-minute walk distance of 15.8m (∧32.3/0.8) in linear models.

Conclusions

The TelePR maintenance strategy was both feasible and safe but failed to show superiority over usual care, despite improvements in some HRQoL domains. Acute exacerbations may have an important negative influence on long-term physical function.

ClinicalTrials.gov identifier

NCT03247933.

Keywords:
Chronic obstructive pulmonary disease
Telerehabilitation Programme
Maintenance
Abbreviations:
ANCOVa
BODE
COPD
CG
CRQ
HRQoL
IG
PR
SF-36
TelePR
6MWT
Resumen
Contexto previo

Existe incertidumbre con respecto a la eficacia de los enfoques basados en telesalud en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) para mantener los beneficios logrados con la rehabilitación pulmonar (RP) intensiva.

Pregunta de investigación

Determinar si un programa de telerrehabilitación pulmonar de mantenimiento (TeleRP), despuèc)s de una RP inicial intensiva, es superior a la atención habitual para mantener en el tiempo los beneficios logrados por la RP intensiva.

Diseño del estudio y mèc)todos

Se realizó un ensayo clínico aleatorizado, pragmático, abierto, multicèc)ntrico, de grupos paralelos. Se crearon 2 grupos al finalizar un programa de RP intensiva en rèc)gimen ambulatorio de 8 semanas de duración. A los pacientes del grupo de intervención (GI) se les proporcionó el equipo de entrenamiento apropiado y se les instruyó para realizar 3 sesiones de entrenamiento semanales y enviar los datos de rendimiento a travèc)s de una aplicación a una plataforma web. Se aconsejó a los pacientes del grupo de control (GC) que hicieran ejercicio regularmente (cuidado habitual).

Resultados

Se aleatorizaron 94 pacientes (46 GI, 48 GC). El análisis de covarianza mostró mejoras no significativas en la distancia en la prueba de marcha de 6min (19,9m [IC 95%: ∧4,1/+43,8]) y el cuestionario de enfermedad respiratoria crónica-factor emocional (0,4 puntos [0-0,8]) en el GI. Los modelos lineales mixtos secundarios mostraron mejoras en el GI en las puntuaciones de la sección mental del SF-36 (9,7 [4,0-15,4]) y el cuestionario de enfermedad respiratoria crónica-factor emocional (0,5 puntos [0,2-0,9]), pero no se demostró asociación entre el cumplimiento y los resultados. Las exacerbaciones agudas se asociaron con una disminución marginalmente significativa en la distancia en la prueba de la marcha de 6min de 15,8m (∧32,3/0,8) en los modelos lineales.

Conclusiones

La estrategia de mantenimiento TeleRP fue viable y segura, pero no se demostró superioridad frente al cuidado habitual, a pesar de las mejoras en algunos aspectos en las valoraciones de la calidad de vida en relación con la salud. Las exacerbaciones agudas podrían tener una influencia negativa importante en la función física a largo plazo.

Identificador ClinicalTrials.gov

NCT03247933.

Palabras clave:
Enfermedad pulmonar obstructiva crónica
Programa de telerrehabilitación
Mantenimiento

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