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Respiratory Muscle Training and Walking Exercise in Women Recovering From COVID-19 Pneumonia (RECOVID-EX)

15 juin 2026 mis à jour par: Mehmet İsmail TOSUN, Hitit University

Investigation of the Effects of Respiratory Muscle Training and Walking Exercises on Some Blood and Respiratory Parameters in Patients Recovering From COVID-19 Lung Inflammation

This experimental study was designed to investigate the effects of respiratory muscle training and walking exercise on selected blood, respiratory, functional, dyspnea, sleep quality, and quality-of-life outcomes in women who had recovered from COVID-19-related lung inflammation/pneumonia. The study included women aged 20 to 45 years who had experienced COVID-19 with pneumonia, reported dyspnea, and had reduced quality of life.

A total of 80 female participants were divided into four groups: respiratory muscle training plus walking exercise, respiratory muscle training alone, walking exercise alone, and a control group, with 20 participants in each group. Measurements were performed before and after the intervention period. The assessments included pulmonary function testing, maximal inspiratory pressure, the 6-minute walk test, the modified Borg scale for dyspnea, the Nottingham Health Profile, the Pittsburgh Sleep Quality Index, and selected blood parameters. The study aimed to determine whether respiratory muscle training, walking exercise, or their combination could improve respiratory function, inspiratory muscle strength, functional capacity, dyspnea, sleep quality, quality of life, and blood-related parameters in this population.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This was a single-blind, experimental, pretest-posttest intervention study conducted in adult women who had recovered from COVID-19-related pneumonia and continued to experience dyspnea during the post-discharge period. Participants were recruited from routine post-discharge follow-up settings and were informed about the study procedures before participation. Written informed consent was obtained from all participants before any study-related procedures were performed.

Before the start of the intervention period, participants completed a familiarization session and trial measurements to reduce learning-related variability during the actual assessments. Baseline measurements were then performed, and participants were allocated into four study groups according to their pretest results: respiratory muscle training, respiratory muscle training plus walking exercise, walking exercise, and control.

The respiratory muscle training intervention was performed for 8 weeks using a pressure-threshold respiratory muscle training device. The training load was set at 50% of each participant's maximal inspiratory pressure. Participants in the respiratory muscle training group performed the intervention 5 days per week, twice daily, with 30 breaths in each session. Respiratory muscle strength was reassessed weekly, and the training load was updated according to changes in maximal inspiratory pressure.

The combined intervention group completed the same respiratory muscle training protocol in addition to a structured walking exercise program. The walking exercise consisted of 40 minutes of walking, 3 days per week, either outdoors or on a treadmill, at a pace of approximately 4 to 6 km/hour. Exercise intensity was prescribed using a target heart rate approach corresponding to 40% intensity and was monitored during the sessions with an optical heart rate sensor. Before walking exercise, participants completed a 10-minute warm-up and stretching routine for the upper and lower extremities.

The walking exercise group completed only the structured walking program using the same frequency, duration, intensity, and monitoring procedures as the walking component of the combined intervention group. The control group did not receive a structured exercise intervention and continued their usual daily routine during the study period.

Study data were collected using individual participant forms. These forms included health history, medication use, smoking status, previous physical activity status, basic physical characteristics, and all pre- and post-intervention measurement values. The intervention process and exercise sessions were monitored throughout the study period. Measurements were repeated after the 8-week intervention period to evaluate changes within and between the study groups.

Type d'étude

Interventionnel

Inscription (Réel)

80

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

  • Turquie (Türkiye)
    • Çorum
      • Çorum, Çorum, Turquie (Türkiye), 19100
        • Hitit University Çorum Erol Olçok Training and Research Hospital

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

  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Female participants aged 20 to 45 years
  • History of COVID-19-related pneumonia
  • Presence of dyspnea after COVID-19
  • Modified Borg dyspnea score between 1 and 7 after the 6-minute walk test
  • Resting oxygen saturation between 90% and 95%
  • Incomplete resolution of COVID-19-related lesions on chest radiography
  • Voluntary agreement to participate in the study
  • Signed written informed consent form

Exclusion Criteria:

  • Modified Borg dyspnea score between 0 and 1
  • Modified Borg dyspnea score greater than 7
  • History of chronic obstructive pulmonary disease, heart failure, or pulmonary fibrosis causing dyspnea before COVID-19 pneumonia
  • Upper abdominal or thoracic surgery within the previous 3 months
  • Cancer
  • Pregnancy
  • Presence of another disease contributing to dyspnea in addition to COVID-19-related dyspnea
  • Cardiovascular, musculoskeletal, or nervous system involvement related to COVID-19
  • Mental disorder or mental instability
  • Language barrier preventing understanding of Turkish
  • Refusal to participate or withdrawal from the study at any stage
  • History of being a competitive athlete
  • Lack of voluntary participation or refusal to sign the written informed consent form

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: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Respiratory Muscle Training
Participants in this arm received respiratory muscle training for 8 weeks using a pressure-threshold respiratory muscle training device. The training intensity was set at 50% of each participant's maximal inspiratory pressure and was updated according to weekly changes in respiratory muscle strength.
Comportemental: Respiratory Muscle Training
Participants performed respiratory muscle training for 8 weeks using a pressure-threshold respiratory muscle training device. The training load was set at 50% of each participant's maximal inspiratory pressure. Training was performed 5 days per week, twice daily, with 30 breaths in each session. Maximal inspiratory pressure was reassessed weekly, and the training load was adjusted according to the updated value.
Expérimental: Respiratory Muscle Training Plus Walking Exercise
Participants in this arm received respiratory muscle training in addition to a structured walking exercise program for 8 weeks. The walking exercise was performed 3 days per week for 40 minutes at 40% intensity based on the target heart rate method, either outdoors or on a treadmill. Exercise intensity was monitored using an optical heart rate sensor.
Comportemental: Respiratory Muscle Training
Participants performed respiratory muscle training for 8 weeks using a pressure-threshold respiratory muscle training device. The training load was set at 50% of each participant's maximal inspiratory pressure. Training was performed 5 days per week, twice daily, with 30 breaths in each session. Maximal inspiratory pressure was reassessed weekly, and the training load was adjusted according to the updated value.
Comportemental: Walking Exercise
Participants performed a structured walking exercise program for 8 weeks. Walking exercise was performed 3 days per week for 40 minutes at an intensity corresponding to 40% based on the target heart rate method. Walking was performed either outdoors or on a treadmill at an approximate pace of 4 to 6 km/hour. Exercise intensity was monitored using a Polar Verity Sense optical heart rate sensor. Before walking, participants completed a 10-minute warm-up and stretching protocol for the upper and lower extremities.
Expérimental: Walking Exercise
Participants in this arm performed structured walking exercise for 8 weeks. Walking was performed 3 days per week for 40 minutes at a pace of approximately 4-6 km/hour and at 40% intensity based on the target heart rate method. Exercise intensity was monitored during the sessions using an optical heart rate sensor.
Comportemental: Walking Exercise
Participants performed a structured walking exercise program for 8 weeks. Walking exercise was performed 3 days per week for 40 minutes at an intensity corresponding to 40% based on the target heart rate method. Walking was performed either outdoors or on a treadmill at an approximate pace of 4 to 6 km/hour. Exercise intensity was monitored using a Polar Verity Sense optical heart rate sensor. Before walking, participants completed a 10-minute warm-up and stretching protocol for the upper and lower extremities.
Aucune intervention: Control
Participants in this arm did not receive any structured exercise intervention and continued their usual daily routine during the study period.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Maximal Inspiratory Pressure
Délai: Baseline and Week 8
Change in maximal inspiratory pressure from baseline to post-intervention. Maximal inspiratory pressure was used to assess inspiratory respiratory muscle strength.
Baseline and Week 8

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Forced Vital Capacity
Délai: Baseline and Week 8
Change in forced vital capacity from baseline to Week 8. Forced vital capacity was assessed using pulmonary function testing and reported in liters.
Baseline and Week 8
Change in Forced Expiratory Volume in 1 Second
Délai: Baseline and Week 8
Change in forced expiratory volume in 1 second from baseline to Week 8. Forced expiratory volume in 1 second was assessed using pulmonary function testing and reported in liters.
Baseline and Week 8
Change in Peak Inspiratory Flow
Délai: Baseline and Week 8
Change in peak inspiratory flow from baseline to Week 8. Peak inspiratory flow was assessed as a respiratory function parameter and reported in liters per second.
Baseline and Week 8
Change in Inspiratory Volume
Délai: Baseline and Week 8
Change in inspiratory volume from baseline to Week 8. Inspiratory volume was assessed as a respiratory function parameter and reported in liters.
Baseline and Week 8
Change in 6-Minute Walk Test Distance
Délai: Baseline and Week 8
Change in functional exercise capacity from baseline to post-intervention, assessed by the 6-minute walk test.
Baseline and Week 8
Change in Modified Borg Dyspnea Score
Délai: Baseline and Week 8
Change in perceived dyspnea from baseline to post-intervention, assessed using the modified Borg scale.
Baseline and Week 8
Change in Nottingham Health Profile Score
Délai: Baseline and Week 8
Change in health-related quality of life from baseline to post-intervention, assessed using the Nottingham Health Profile.
Baseline and Week 8
Change in Pittsburgh Sleep Quality Index Score
Délai: Baseline and Week 8
Change in sleep quality from baseline to post-intervention, assessed using the Pittsburgh Sleep Quality Index.
Baseline and Week 8
Change in Blood Parameters
Délai: Baseline and Week 8
Change in selected blood parameters from baseline to post-intervention, including leukocyte count, erythrocyte count, and hemoglobin.
Baseline and Week 8

Collaborateurs et enquêteurs

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

Parrainer

Hitit University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • Tosun MI. Investigation of the Effects of Respiratory Muscle Training and Walking Exercises on Some Blood and Respiratory Parameters in Patients Recovered From COVID-19 Lung Inflammation. Doctoral dissertation. Hitit University, Graduate School, Department of Physical Education and Sports; 2023.

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)

16 janvier 2023

Achèvement primaire (Réel)

26 mai 2023

Achèvement de l'étude (Réel)

29 mai 2023

Dates d'inscription aux études

Première soumission

11 juin 2026

Première soumission répondant aux critères de contrôle qualité

15 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2022-98

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared publicly because the dataset contains personal health-related information collected from female participants who had recovered from COVID-19-related pneumonia. The data were collected as part of a doctoral thesis study and were analyzed in de-identified form for the purposes of the study.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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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