- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07656610
Respiratory Muscle Training and Walking Exercise in Women Recovering From COVID-19 Pneumonia (RECOVID-EX)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Çorum
-
Çorum, Çorum, Turchia (Türkiye), 19100
- Hitit University Çorum Erol Olçok Training and Research Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Sperimentale: 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.
|
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.
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.
|
|
Sperimentale: 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.
|
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.
|
|
Nessun intervento: Control
Participants in this arm did not receive any structured exercise intervention and continued their usual daily routine during the study period.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Maximal Inspiratory Pressure
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Forced Vital Capacity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni delle vie respiratorie
- Infezioni
- Infezioni da virus a RNA
- Malattie virali
- Malattie delle vie respiratorie
- Malattie polmonari
- Disturbi respiratori
- Polmonite, virale
- Polmonite
- Infezioni da coronavirus
- Infezioni da Coronaviridae
- Infezioni da Nidovirus
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- COVID-19
- Dispnea
- Segni e sintomi, respiratori
- Terapie
- Terapie mind-body
- Terapie complementari
- Tecniche di movimento degli esercizi
- Modalità di terapia fisica
- Esercizi di respirazione
Altri numeri di identificazione dello studio
- 2022-98
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Polmonite COVID-19
-
PfizerAttivo, non reclutanteCOVID-19 | Malattia da coronavirus 2019 (COVID-19) | Infezione da covid-19 | Vaccini contro il covid-19 | Infezione da SARS-CoV-2, COVID19 | Vaccinazione COVID-19 | Infezione da SARS-CoV-2, COVID-19 | COVID-19 (Coronavirus 2019) | Infezione da COVID-19 SARS-CoV-2Stati Uniti
-
Shanghai Public Health Clinical CenterNon ancora reclutamento
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Completato
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)ReclutamentoCondizione post COVID-19 | Post COVID-19 | Sindrome post COVID-19 | Sindrome lunga da COVID-19 | Condizione post COVID-19 (PCC)Germania
-
PfizerReclutamentoMalattie delle vie respiratorie | COVID-19 | Polmonite | Malattie polmonari | Malattia di coronavirus 2019 | Malattia da coronavirus 2019 (COVID-19) | Infezione da covid-19 | Infezioni del tratto respiratorio superiore | Infezione del tratto respiratorio | COVID-19 (Coronavirus 2019) | Infezione da COVID-19...Belgio
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaReclutamentoFatica | Sindrome post-COVID-19 | Condizione post COVID-19 | Sindrome post-COVID | Lungo COVID-19 | Lungo-COVID | Condizione post-COVIDCanada
-
ModeX Therapeutics, An OPKO Health CompanyReclutamentoCOVID 19 | COVID-19 (Prevenzione)Stati Uniti
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios...CompletatoSequele post acute di COVID-19 | Condizione post COVID-19 | Lungo-COVID | Sindrome cronica da COVID-19Italia
-
Indonesia UniversityReclutamentoSindrome post-COVID-19 | Lungo COVID | Condizione post COVID-19 | Sindrome post-COVID | Lungo COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNon ancora reclutamentoSindrome post-COVID-19 | Lungo COVID | Lungo Covid19 | Condizione post COVID-19 | Sindrome post-COVID | Condizione post COVID-19, non specificata | Condizione post-COVIDOlanda
Prove cliniche su Respiratory Muscle Training
-
QIAGEN Gaithersburg, IncCompletatoMalattia respiratoriaRegno Unito
-
Guy's and St Thomas' NHS Foundation TrustPhilips HealthcareCompletato
-
Stanford UniversityCompletatoSindrome da deficit di attenzione e iperattivitàStati Uniti
-
Nottingham University Hospitals NHS TrustCompletato
-
Dario KohlbrennerCompletato
-
University of Maryland, College ParkNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletatoDisturbi percettivi uditivi | Problemi di invecchiamentoStati Uniti
-
KTO Karatay UniversityCompletatoIctus | Riabilitazione dell'ictusTacchino
-
Zhujiang HospitalReclutamentoDisturbi della coscienza | Stato di minima coscienza | Stato vegetativoCina
-
Institut d'Investigació Biomèdica de Girona Dr....Attivo, non reclutanteRiabilitazione | Infezione respiratoria da COVID-19 | FisioterapistiSpagna
-
Chang Gung UniversityCompletato