- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07646288
Acute Effects of Visual Feedback-Assisted Inspiratory Muscle Training After Lobectomy
Evaluation of the Acute Effects of Respiratory Muscle Strength Training With Visual Feedback in Lung Cancer Patients Undergoing Lobectomy
Panoramica dello studio
Stato
Descrizione dettagliata
Lung cancer is one of the leading causes of cancer-related mortality worldwide. In patients with early-stage non-small cell lung cancer, surgical resection remains the main curative treatment option. Lobectomy, particularly through video-assisted thoracic surgery, is commonly performed as an anatomical resection method. However, despite the advantages of minimally invasive thoracic surgery, patients may experience postoperative pulmonary complications, impaired respiratory muscle function, pain-related breathing limitations, and reduced exercise capacity after lobectomy.
Inspiratory muscle training is commonly used as part of postoperative physiotherapy and pulmonary rehabilitation after thoracic surgery. Because inspiratory muscle training requires active patient participation and effort, exercise motivation and adherence are important determinants of effective implementation. Recent technological developments have enabled the use of mobile application-supported systems and smart adaptors that provide visual feedback during inspiratory muscle training. Visual feedback may improve patient motivation, participation, and usability of the training. However, the acute effects of mobile application-supported inspiratory muscle training with visual feedback have not been adequately investigated in patients undergoing lobectomy after lung cancer surgery.
This study is designed to evaluate the acute effects of conventional inspiratory muscle training and visual feedback-assisted inspiratory muscle training on exercise motivation, dyspnea perception, usability, and patient satisfaction in lung cancer patients undergoing lobectomy via video-assisted thoracic surgery. The study will include clinically stable volunteers aged 18-75 years who are scheduled for lobectomy due to lung cancer and who are able to cooperate with the planned assessments. A total of 40 participants is planned.
Preoperative assessments will be performed on the day before surgery. Demographic and clinical characteristics, including age, height, body weight, smoking history, previous surgeries, and pulmonary function test results, will be recorded. Respiratory muscle strength will be assessed by measuring maximal inspiratory pressure and maximal expiratory pressure using a mouth pressure device.
The intervention will be performed on postoperative day 1 after the patient has been transferred to the ward. First, participants will perform conventional inspiratory muscle training without mobile application support or visual feedback in the morning. After at least two hours of rest, the same inspiratory muscle training protocol will be repeated with a smart adaptor connected to a mobile application, providing visual feedback during the exercise. Inspiratory muscle training will be performed using a threshold-loading device at 40% of maximal inspiratory pressure, with three sets of ten breaths during each session.
After each training session, exercise motivation, dyspnea perception, and patient satisfaction will be evaluated. Exercise motivation will be assessed using the Exercise Motivation Attitude Scale. Dyspnea perception will be assessed using the Modified Borg Scale before and after each intervention. Patient satisfaction, perceived difficulty of training, willingness to continue training, and perceived benefit will be evaluated using 0-10 rating scales. For the mobile application-assisted session, usability will also be assessed using the System Usability Scale. In addition, mobile application-derived data, including the number of successful breaths, total training duration, and total number of breaths, will be recorded.
The primary aim of the study is to determine whether visual feedback-assisted inspiratory muscle training provides more favorable acute effects on exercise motivation and patient adherence compared with conventional inspiratory muscle training. Secondary aims include evaluating dyspnea perception, usability of the mobile application-supported system, patient satisfaction, and objective training data obtained from the smart adaptor. The findings may contribute to the development of technology-supported pulmonary rehabilitation strategies after lobectomy and may guide the integration of visual feedback systems into routine postoperative respiratory physiotherapy.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Funda Alma, MsC
- Numero di telefono: +905079394348
- Email: funda.sirakaya@hacettepe.edu.tr
Luoghi di studio
-
-
Altındağ
-
Ankara, Altındağ, Turchia (Türkiye), 06230
- Reclutamento
- Hacettepe University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Volunteering to participate in the study,
- Being clinically stable,
- Being a lung cancer patient scheduled for lobectomy,
- Being between 18 and 75 years of age,
- Being able to cooperate with the tests to be performed.
Exclusion Criteria:
- Presence of any orthopedic or neurological problem that prevents walking,
- History of any surgery involving the thoracic wall,
- Having diseases that may affect respiratory parameters, such as severe heart failure or severe chronic obstructive pulmonary disease (COPD).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Conventional IMT Followed by Visual Feedback-Assisted IMT
Participants randomized to this arm will first receive conventional inspiratory muscle training without visual feedback.
After a rest period of at least two hours, they will receive visual feedback-assisted inspiratory muscle training using a smart adaptor connected to a mobile application.
Both training sessions will be performed using a threshold-loading inspiratory muscle training device at 40% of maximal inspiratory pressure, with three sets of ten breaths.
|
Conventional inspiratory muscle training will be performed without visual feedback or mobile application support.
Training will be delivered using a threshold-loading inspiratory muscle training device at 40% of maximal inspiratory pressure, with three sets of ten breaths.
Visual feedback-assisted inspiratory muscle training will be performed using a threshold-loading inspiratory muscle training device connected to a smart adaptor and mobile application.
The mobile application will provide visual feedback during training.
Training will be performed at 40% of maximal inspiratory pressure, with three sets of ten breaths.
Application-derived data, including the number of successful breaths, total training duration, and total number of breaths, will be recorded.
|
|
Sperimentale: Visual Feedback-Assisted IMT Followed by Conventional IMT
Participants randomized to this arm will first receive visual feedback-assisted inspiratory muscle training using a smart adaptor connected to a mobile application.
After a rest period of at least two hours, they will receive conventional inspiratory muscle training without visual feedback.
Both training sessions will be performed using a threshold-loading inspiratory muscle training device at 40% of maximal inspiratory pressure, with three sets of ten breaths.
|
Conventional inspiratory muscle training will be performed without visual feedback or mobile application support.
Training will be delivered using a threshold-loading inspiratory muscle training device at 40% of maximal inspiratory pressure, with three sets of ten breaths.
Visual feedback-assisted inspiratory muscle training will be performed using a threshold-loading inspiratory muscle training device connected to a smart adaptor and mobile application.
The mobile application will provide visual feedback during training.
Training will be performed at 40% of maximal inspiratory pressure, with three sets of ten breaths.
Application-derived data, including the number of successful breaths, total training duration, and total number of breaths, will be recorded.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Exercise Motivation
Lasso di tempo: Immediately after each intervention on postoperative day 1-2.
|
Exercise motivation will be assessed using the Exercise Motivation Scale after each inspiratory muscle training condition.
The scale includes subdomains related to negative attitudes and thoughts, positive perspective and health, and physical appearance and health.
Higher scores indicate higher exercise motivation.
Scores obtained after conventional inspiratory muscle training and visual feedback-assisted inspiratory muscle training will be compared.
|
Immediately after each intervention on postoperative day 1-2.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dyspnea Perception
Lasso di tempo: Before and immediately after each intervention on postoperative day 1-2.
|
Dyspnea perception will be assessed using the Modified Borg Scale before and after each inspiratory muscle training condition.
The scale is used to evaluate perceived breathlessness, with higher scores indicating greater dyspnea severity.
Changes in dyspnea perception will be compared between conventional inspiratory muscle training and visual feedback-assisted inspiratory muscle training.
|
Before and immediately after each intervention on postoperative day 1-2.
|
|
System Usability
Lasso di tempo: Immediately after each intervention on postoperative day 1-2.
|
The usability of the conventional inspiratory muscle training and visual feedback-assisted inspiratory muscle training system will be assessed using the System Usability Scale after the inspiratory muscle training session.
Higher scores indicate better perceived usability.
|
Immediately after each intervention on postoperative day 1-2.
|
|
Respiratory Muscle Strength
Lasso di tempo: Preoperative day, one day before surgery.
|
Respiratory muscle strength will be assessed preoperatively by measuring maximal inspiratory pressure and maximal expiratory pressure using a mouth pressure device.
These measurements will be used to determine the training intensity and to characterize baseline respiratory muscle function.
|
Preoperative day, one day before surgery.
|
|
Patient Satisfaction
Lasso di tempo: Immediately after each intervention on postoperative day 1-2.
|
Patient satisfaction with each inspiratory muscle training condition will be evaluated using 0-10 rating scales.
Participants will be asked to rate perceived training difficulty, willingness to continue training, and perceived benefit from the training.
Scores will be compared between conventional inspiratory muscle training and visual feedback-assisted inspiratory muscle training.
|
Immediately after each intervention on postoperative day 1-2.
|
|
Training Performance Data Recorded by the Mobile Application
Lasso di tempo: During the visual feedback-assisted intervention on postoperative day 1-2.
|
For the visual feedback-assisted inspiratory muscle training session, application-derived training data will be recorded, including the number of successful breaths, total training duration, and total number of breaths.
|
During the visual feedback-assisted intervention on postoperative day 1-2.
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- E-81471704-050-00004500476
- THD-2025-22286 (Altro numero di sovvenzione/finanziamento: Hacettepe University Scientific Research Projects Coordination Unit)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (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 Esercizio di formazione
-
Riphah International UniversityCompletato
-
Ataturk UniversityCompletatoMindfulness Compassion -Living TrainingTacchino
-
Saglik Bilimleri UniversitesiCompletato
-
Teesside UniversityLiverpool John Moores UniversityCompletatoInterval training ad alta intensità
-
The University of Hong KongHong Kong Jockey Club Innovative Learning Centre for MedicineCompletatoTraining di simulazione, laparoscopiaHong Kong
-
Teesside UniversityCompletato
-
Inje UniversityCompletatoRianimazione cardiopolmonare, training di simulazioneCorea, Repubblica di
-
Muhammed ŞAHİNCompletatoPrestazioni atletiche | Idoneità fisica | Interval training ad alta intensitàTurchia (Türkiye)
-
York St John UniversityYork City Baths ClubAttivo, non reclutanteNuoto | Protocolli di esercizio di Power Training | Effetti dell'allenamento della forzaRegno Unito
-
Aalborg UniversityUniversity of CopenhagenReclutamentoDeliberate Practice Training di abilità psicoterapeutiche | Insegnamento teorico delle abilità psicoterapeuticheDanimarca
Prove cliniche su Conventional Inspiratory Muscle Training
-
Uskudar UniversityCompletatoLombalgiaTurchia (Türkiye)
-
Kirsehir Ahi Evran UniversitesiReclutamento