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Comparaison des recommandations de téléréadaptation pulmonaire et d'activité physique chez les patients atteints de fibrose post-covid

29 septembre 2026 mis à jour par: Ozge Ertan, Istanbul University - Cerrahpasa

Comparaison de l'efficacité des recommandations de téléréadaptation pulmonaire et d'activité physique chez les patients atteints de fibrose pulmonaire due au COVID-19

Rehabilitation plays a very important role in the management of patients with COVID-19, focusing on respiratory and motor functions, and therefore the importance of establishing treatment strategies to ensure optimal recovery of these patients has been emphasized. It has been stated that physical activity recommendations should be clarified for the management of symptoms associated with prolonged COVID-19 Syndrome and for the continuation of activities of daily living. It has been stated that after COVID-19 pneumonia, it is necessary to evaluate the physical functions of patients with long-term follow-up and to establish rehabilitation programs. The importance of being included in the rehabilitation program was emphasized, especially for patients with lung fibrosis.

The primary aim of this study was to compare the effects of pulmonary telerehabilitation and physical activity recommendations on exercise capacity and peripheral muscle strength in patients with pulmonary fibrosis due to COVID-19.

The secondary aim of this study is to compare the effects of pulmonary telerehabilitation and physical activity recommendations on symptoms, activity and participation in patients with pulmonary fibrosis due to COVID-19.

Aperçu de l'étude

Statut

Complété

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • >18 years old
  • Patients who have been infected with the COVID-19 virus at least 12 months ago and have been diagnosed with a positive PCR
  • Patients with post-COVID-19 pulmonary fibrosis followed by a pulmonologist
  • Patients who have sufficient technological infrastructure to participate in the telerehabilitation program and can adapt to online systems
  • Patients who are clinically stable

Exclusion Criteria:

  • Patients with orthopedic/neurological problems that prevent walking and exercise
  • Patients with uncontrolled cardiovascular disease
  • Patients with uncontrolled medical conditions

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Pulmonary Rehabilitation Group

A total of 24 sessions of breathing exercises and high-repetitive muscle endurance and strengthening exercises will be applied to the pulmonary telerehabilitation group for 8 weeks, two days a week and one day a week unsupervised, via online systems. High-repetition muscle endurance and strengthening exercises will be applied to large muscle groups of the lower and upper extremities by creating resistance with body weight and theraband.

High repetition muscle endurance and strengthening exercises Walking

Comparateur actif: Physical Activity Group

Respiratory exercises and physical activity recommendations will be given to the physical activity group. Physical activity recommendations are; It will include information about the importance of physical activity and walking 3-5 days a week for at least 30 minutes of moderate intensity (4-6 on the Modified Borg scale of perceived exertion level).

High repetition muscle endurance and strengthening exercises Walking

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Submaximal exercise capacity
Délai: 1 week-8 week

Six minute walk test and

1 week-8 week
maximal exercise capacity
Délai: 1 week-8 week

Incremental shuttle walk test

1 week-8 week
endurance exercise capacity
Délai: 1 week-8 week

endurance shuttle walk test

1 week-8 week
Peripheral muscle strength
Délai: 1 week-8 week

Hand-held dynamometer

1 week-8 week
Functional exercise capacity
Délai: 1 week-8 week

1 min sit to stand test

1 week-8 week

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Physical activity
Délai: 1 week-8 week also Participants will monitor their weekly step counts during the study

Pedometer

1 week-8 week also Participants will monitor their weekly step counts during the study
Physical activity
Délai: 1 week-8 week

Physical activity will be assessed using a SenseWear Armband (BodyMedia Inc., Pittsburgh, PA, USA), worn for at least 72 hours.

1 week-8 week
Dyspnea
Délai: 1 week-8 week

Modified Medical Research Council Dyspnea Scale stratifies severity of dyspnea in respiratory diseases. The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing

1 week-8 week
Fatigue
Délai: 1 week-8 week

The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on patients. The FSS is a short questionnaire that requires to rate your level of fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. Patients read each statement and circle a number from 1 to 7, based on how accurately it reflects their condition during the past week and how much they agree or disagree that the statement applies to patients. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. Total score between 9-63. A total score of less than 36 suggests that you may not be suffering from fatigue.

1 week-8 week
Functionality
Délai: 1 week-8 week

Post covid-19 functionality scale (PCFS): The PCFS scale stratifies functional status limitation as follows: grade 0 (No functional limitations), grade 1 (Negligible functional limitations), grade 2 (Slight functional limitations), grade 3 (Moderate functional limitations), grade 4 (Severe functional limitations), and grade 5 (death)

1 week-8 week
Emotional status
Délai: 1 week-8 week

Hospital anxiety and depression scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).

1 week-8 week
Body composition
Délai: 1 week-8 week

Bioelectrical impedence analysis

1 week-8 week
Activities of daily living
Délai: 1 week-8 week

London chest activity of daily living scale: Perceived dyspnea while performing daily living activities is scored between 0-5. A high score indicates greater disability in performing ADLs. The minimum score 0 and maximum total score is 75.

1 week-8 week

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Pulmonary Telerehabilitation Feasibility
Délai: 8 week

Changes in clinical status will be assessed using the 'Global Change Scale' in order to determine the programme's effect on clinical status.

8 week
Pulmonary Telerehabilitation Feasibility
Délai: 8 week

Adherence and drop-out rate

8 week
Pulmonary Telerehabilitation Feasibility
Délai: 8 week

System usability: The usability of the telerehabilitation system was assessed using the "System Usability Scale (SUS)".

8 week
Pulmonary Telerehabilitation Feasibility
Délai: 8 week

Safety

8 week

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 septembre 2022

Achèvement primaire (Réel)

7 mars 2025

Achèvement de l'étude (Réel)

7 mars 2025

Dates d'inscription aux études

Première soumission

25 mars 2022

Première soumission répondant aux critères de contrôle qualité

28 mars 2022

Première publication (Réel)

29 mars 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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