Effectiveness of Respiratory Muscle Training with a Mobile Application After Lobectomy

NCT06813144 | Not Yet Recruiting

• 1 other identifier: E-30603717-050.04-2400055696
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lung cancer; vats; inspiratory muscle training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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 first-fifth days.

• Exercise Motivation

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

• Dyspnea Level

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

• Quality of Life

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

Study Arms (3)

Classic IMT

ACTIVE COMPARATOR

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

IMT with mobile application

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

inspiratory muscle exercise OTHER

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

Classic IMT; IMT with mobile application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Ebru Calik Kutukcu, Professorr

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Funda Alma, MsC

CONTACT

+905079394348; fundasirakaya@outlook.com

Ebru Calik Kutukcu, Professor

CONTACT

+905442850087; ebru.calik@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blind (participant and statistician)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD student, physiotherapist

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 6, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-01

Locations

TU (1)