Effectiveness of Respiratory Muscle Training with a Mobile Application After Lobectomy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracic Surgery; Respiratory Muscle; Video Assisted Thoracic Surgery (VATS); Lung Cancer (NSCLC)
• Intervention / Treatment: Other: inspiratory muscle exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Funda Alma, MsC; Phone Number: +905079394348; Email: fundasirakaya@outlook.com
• Study Contact Backup: Name: Ebru Calik Kutukcu, Professor; Phone Number: +905442850087; Email: ebru.calik@hacettepe.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: inspiratory muscle exercise; Inspiratory muscle training will be given with or without smart adaptor.
Experimental: 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.	Other: inspiratory muscle exercise; Inspiratory muscle training will be given with or without smart adaptor.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory muscle strength	Respiratory muscle strength will measure by measuring mouth pressure and using maximal inspiratory pressure (MIP) values.	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).
Expiratory muscle strength	Respiratory muscle strength will measure by measuring mouth pressure and using maximal expiratory pressure (MEP) values.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional exercise capacity	6-minute walk test (6MWT) will be used to evaluate functional exercise capacity.	Evaluations will be made before surgery (the day before surgery) and during the follow-up period (10-15 days after discharge).
Postoperative Pulmonary Complications	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.	Postoperative first-fifth days.
Exercise Motivation	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).	The evaluation will be made during the control period (10-15 days after discharge).
Dyspnea Level	Modified Borg Scale will be used to evaluate dyspnea.	An evaluation will be made in the preoperative (the day before surgery) and control period (10-15 days after discharge).
Quality of Life	SF-12 Quality of Life Scale will be used to assess quality of life.	The evaluation will be made during the preoerative (the day before surgery) and control (10-15 days after discharge) period.
Physical Performance	The Short Physical Performance Battery, a frequently used test in cardiovascular and pulmonary diseases, will be used.	Evaluations will be made in the preoperative (the day before surgery) and control (10-15 days after discharge) periods.

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: Ebru Calik Kutukcu, Professorr, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: lung cancer; inspiratory muscle training; vats
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Aortic Diseases; Aneurysm; Lung Neoplasms; Aortic Dissection
• Other Study ID Numbers: E-30603717-050.04-2400055696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No