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

Lung Cancer Clinical Trial

Official title: Respiratory Muscle Strength, Functional Capacity and Subjective Outcome - Effects of Inspiratory Muscle Training After Lung Cancer Surgery, a Randomized Controlled Trial

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Respiratory Aspiration
• Surgery

• NCT number: NCT01793155
• Study type: Interventional
• Source: Aalborg Universitetshospital
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Completion date: December 2014