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Acute Effects of Visual Feedback-Assisted Inspiratory Muscle Training After Lobectomy

9 czerwca 2026 zaktualizowane przez: Funda Sirakaya, Hacettepe University

Evaluation of the Acute Effects of Respiratory Muscle Strength Training With Visual Feedback in Lung Cancer Patients Undergoing Lobectomy

This study aims to evaluate the acute effects of inspiratory muscle training performed with and without a mobile application providing visual feedback on exercise motivation, patient adherence, dyspnea perception, usability, and patient satisfaction in lung cancer patients undergoing lobectomy via video-assisted thoracic surgery. Participants will perform conventional inspiratory muscle training without visual feedback in the morning on postoperative day 1 after transfer to the ward. After at least two hours of rest, the same exercise protocol will be repeated with a smart adaptor connected to a mobile application to provide visual feedback. Inspiratory muscle training will be performed using a threshold-loading device at 40% of maximal inspiratory pressure, with three sets of ten breaths. Outcomes will be assessed before and/or after each session as appropriate.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

    • Altındağ
      • Ankara, Altındağ, Turcja (Türkiye), 06230
        • Rekrutacyjny
        • Hacettepe University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Eksperymentalny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Exercise Motivation
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Dyspnea Perception
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 grudnia 2025

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

1 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

9 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

12 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • E-81471704-050-00004500476
  • THD-2025-22286 (Inny numer grantu/finansowania: Hacettepe University Scientific Research Projects Coordination Unit)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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Badania kliniczne na Ćwiczenia treningowe

Badania kliniczne na Conventional Inspiratory Muscle Training

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