Effects of Inspiratory Muscle Training After Lung Cancer Surgery, a Randomized Controlled Trial

Phase 2

Completed

• Conditions: Lung Cancer; Surgery
• Interventions: Other: Inspiratory muscle training

• Registration Number: NCT01793155
• Lead Sponsor: Aalborg University Hospital

Brief Summary

The purpose of this study is to evaluate the effects of postoperative inspiratory muscle training on the recovery of respiratory muscle strength in high risk patients referred for lung cancer surgery. Furthermore, to assess longitudinal changes in respiratory muscle strength, physical capacity and health-related quality of life after lung cancer surgery

Detailed Description

Advances in early detection and treatment improve life expectancy after surgery for lung cancer, but living with lung cancer is frequently associated with symptoms as dyspnoea, decreased physical capacity and fatigue several years after treatment. Lung cancer (LC) surgery is associated with a high incidence of postoperative pulmonary complications (PPC), having a negative impact on recovery. Although the causes of PPC are multifactorial, respiratory muscle (RM) dysfunction has been proposed to be associated with the development of PPC, explained by changes in RM mechanics- and function due to surgery. There is scarcity of literature on the impact of RM dysfunction on surgical and functional outcomes after LC surgery.

Aims: to describe longitudinal changes in RM strength in patients undergoing lung cancer surgery and identify associations between RM strength and functional capacity. Furthermore, to evaluate the effect of inspiratory muscle training on the recovery of respiratory muscle strength in high risk patients referred for LC surgery.

Target population: 88 patients referred for lung cancer surgery at the Department of Cardiothoracic Surgery, Aalborg Universityhospital.

Design: The core of this research is a prospective longitudinal observational study (study 1); included is a randomized controlled trial, based on a subpopulation from study 1.

Statistical analysis is based on mixed linear regression models and ANOVA. For the RCT we use the generalized estimating equivalent method for parametric and Fisher´s exact test for nonparametric data.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Primary Completion: 2014-04
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age >18 years; scheduled for thoracic surgery on the suspicion/confirmed lung tumor via open thoracotomy or Visual Assisted Thoracotomy(includes primary lung cancer, metastases from other cancer sites without activity within none year, other tumor types requiring resection of lung tissue; Furthermore, for RCT, one of the following: Age ≥ 70 years or FEV1 ≤ 70% predicted or DLCO ≤ 70% predicted or scheduled pneumonectomy)

Exclusion Criteria

• physical or mental deficits that adversely influence physical performance; can neither speak nor read Danish; previous ipsilateral lung resection; tumor activity in other sites or organs; pancoast tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle training	Inspiratory muscle training	Inspiratory muscle training for two weeks following surgery

Primary Outcome Measures

Name	Time	Method
Change in inspiratory muscle strength	Before surgery, 5.postoperative day, 2 weeks after surgery	Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Change in expiratory muscle strength	Before surgery, 5 th postoperative day and 2 weeks after surgery	Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery
Incidence of postoperative pulmonary complications	2 weeks after surgery

Trial Locations

Locations (1)

Department of Cardiothoracic Surgery, Aalborg Universityhospital; 🇩🇰 Aalborg, Denmark