Effectiveness of Respiratory Muscle Training with a Mobile Application After Lobectomy

NCT ID: NCT06813144

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-02-01

Brief Summary

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.

Detailed Description

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.

Conditions

Video Assisted Thoracic Surgery (VATS); Thoracic Surgery; Respiratory Muscle; Lung Cancer (NSCLC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Classic IMT

Individuals who are between the ages of 18-65 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery.

The group will receive standard postoperative physiotherapy and rehabilitation as well as classical inspiratory muscle strength training with the noninvasive Powerbreath Medic Plus device (POWERbreathe International Ltd., Warwickshire, England). Training will start with 40 percent of the initial MIP level and progress will be planned according to Modified Borg between 3-4. It will be repeated twice a day for 3 times 10 minutes. Training will start on the 1st postoperative day after the participants are transferred to the ward and they will be asked to continue at home. The progress plan will be adjusted by talking to the patient on the phone every 2 days after discharge.

Group Type: ACTIVE_COMPARATOR

inspiratory muscle exercise

Intervention Type: OTHER

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

IMT with mobile application

Individuals who are between the ages of 18-65 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery.

The group will receive standard postoperative physiotherapy and rehabilitation as well as inspiratory muscle training with the smart adapter support (POWERbreathe International Ltd., Warwickshire, England). Training will start with 40 percent of the initial MIP level and progress will be planned according to Modified Borg between 3-4. It will be repeated twice a day for 3 times 10 minutes. Training will start on the 1st postoperative day after the participants are transferred to the ward and they will be asked to continue at home. The progress plan will be adjusted by talking to the patient on the phone every 2 days after discharge.

Group Type: EXPERIMENTAL

inspiratory muscle exercise

Intervention Type: OTHER

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

control group

Individuals who are between the ages of 18-65 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery.

This group will receive only standard physiotherapy and rehabilitation: respiratory exercises (thoracic expansion exercises, diaphragmatic breathing, incentive spirometry), mobilization and cough/huffing training. Participants will be advised to continue these exercises regularly at home.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

inspiratory muscle exercise

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Funda Sirakaya

PHD student, physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Calik Kutukcu, Professorr

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Funda Alma, MsC

Role: CONTACT

fundasirakaya@outlook.com

+905079394348

Ebru Calik Kutukcu, Professor

Role: CONTACT

ebru.calik@hacettepe.edu.tr

+905442850087

Other Identifiers

E-30603717-050.04-2400055696

Identifier Type: -

Identifier Source: org_study_id