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临床试验/NCT06813144
NCT06813144尚未招募不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
试验地点
1
主要终点
Inspiratory muscle strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

double blind (participant and statistician)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

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.

干预措施: inspiratory muscle exercise (Other)

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.

干预措施: inspiratory muscle exercise (Other)

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.

结局指标

主要结局

Inspiratory muscle strength

时间窗: 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.

Expiratory muscle strength

时间窗: 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.

次要结局

  • Quality of Life(The evaluation will be made during the preoerative (the day before surgery) and control (10-15 days after discharge) period.)
  • 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).)
  • Physical Performance(Evaluations will be made in the preoperative (the day before surgery) and control (10-15 days after discharge) periods.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Funda Sirakaya

PHD student, physiotherapist

Hacettepe University

研究点 (1)

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