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NCT Number: NCT06813144

Effectiveness of Respiratory Muscle Training with a Mobile Application After Lobectomy

It has been observed that there are negative effects on respiratory muscle strength following lobectomy. This has led to the necessity of respiratory muscle training to mitigate these adverse effects. Most studies conducted so far focus on the late postoperative period, and there are only a few studies evaluating the effectiveness of early postoperative inspiratory muscle training (IMT). It is believed that this method could be useful for facilitating patient follow-up and increasing patient motivation through visual feedback.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

It has been observed that there are negative effects on respiratory muscle strength following lobectomy. This has led to the necessity of respiratory muscle training to mitigate these adverse effects. Most studies conducted so far focus on the late postoperative period, and there are only a few studies evaluating the effectiveness of early postoperative inspiratory muscle training (IMT). Additionally, there is currently no study assessing the effectiveness of IMT using a smart adapter in patients who have undergone lobectomy. It is believed that this method could be useful for facilitating patient follow-up and increasing patient motivation through visual feedback. The aim of this study is to examine the changes in respiratory muscle strength and exercise capacity in patients after lobectomy via VATS, comparing classical IMT, mobile application-supported IMT, and a control group that does not receive IMT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteering to participate in the study,
  • Being clinically stable,
  • Being a lung cancer patient with a planned lobectomy with VATS,
  • Being between the ages of 18-65,
  • Being able to cooperate with the tests to be performed.

Exclusion criteria

  • Having any orthopedic or neurological problem that prevents walking,
  • Having undergone any surgery related to the thoracic wall,
  • Having diseases that will affect respiratory parameters such as severe heart failure, severe chronic obstructive pulmonary disease (COPD).

Treatment and study plan

inspiratory muscle exercise

Other

Inspiratory muscle training will be given with or without smart adaptor.

Primary outcomes

  1. Inspiratory muscle strength

    Time frame: Measurements will be performed before surgery (the day before surgery), at discharge and during the follow-up period after surgery (10-15 days after discharge).

    Respiratory muscle strength will measure by measuring mouth pressure and using maximal inspiratory pressure (MIP) values.

  2. Expiratory muscle strength

    Time frame: Measurements will be performed before surgery (the day before surgery), at discharge and during the follow-up period after surgery (10-15 days after discharge).

    Respiratory muscle strength will measure by measuring mouth pressure and using maximal expiratory pressure (MEP) values.

Secondary outcomes

  1. Functional exercise capacity

    Time frame: Evaluations will be made before surgery (the day before surgery) and during the follow-up period (10-15 days after discharge).

    6-minute walk test (6MWT) will be used to evaluate functional exercise capacity.

  2. Postoperative Pulmonary Complications

    Time frame: Postoperative first-fifth days.

    Postoperative pulmonary complications will be evaulate by Melbourne Group Scale. If more than 4 parameters are positive, it will be considered as having postoperative pulmonary complication.

  3. Exercise Motivation

    Time frame: The evaluation will be made during the control period (10-15 days after discharge).

    Exercise Motivation Attitude Scale will be used. This scale consists of 3 sub-dimensions (negative attitude and thought/positive view and health/physical appearance and health).

  4. Dyspnea Level

    Time frame: An evaluation will be made in the preoperative (the day before surgery) and control period (10-15 days after discharge).

    Modified Borg Scale will be used to evaluate dyspnea.

  5. Quality of Life

    Time frame: The evaluation will be made during the preoerative (the day before surgery) and control (10-15 days after discharge) period.

    SF-12 Quality of Life Scale will be used to assess quality of life.

  6. Physical Performance

    Time frame: Evaluations will be made in the preoperative (the day before surgery) and control (10-15 days after discharge) periods.

    The Short Physical Performance Battery, a frequently used test in cardiovascular and pulmonary diseases, will be used.

Study contacts

Contact information is provided by the study sponsor or research team.

Ebru Calik Kutukcu, Professor

CONTACT

[email protected]

+905442850087

Funda Alma, MsC

CONTACT

[email protected]

+905079394348

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Evaluation of the Effectiveness of Respiratory Muscle Training with a Mobile Application in the Early Postoperative Period After Lobectomy

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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