Clinical trial NCT01793155: Effects of Inspiratory Muscle Training After Lung Cancer Surgery, a Randomized Controlled Trial
Official title: Respiratory Muscle Strength, Functional Capacity and Subjective Outcome - Effects of Inspiratory Muscle Training After Lung Cancer Surgery, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Surgery
Keywords: Lung cancer surgery
Inspiratory muscle training
Postoperative pulmonary complications
Functional outcomes
Health related quality of life
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Region Örebro County
name: Örebro University, Sweden
name: KU Leuven
First posted: 2013-02-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in inspiratory muscle strength
timeFrame: Before surgery, 5.postoperative day, 2 weeks after surgery
Secondary outcomes:
measure: Change in expiratory muscle strength
timeFrame: Before surgery, 5 th postoperative day and 2 weeks after surgery
measure: Incidence of postoperative pulmonary complications
timeFrame: 2 weeks after surgery
Other outcomes:
measure: Change in walking distance, 6 minute
timeFrame: before surgery, 5th postoperative day and 2 weeks after surgery
measure: Change in spirometry values(FVC, FEV1)
timeFrame: before surgery, 5th day, 2 weeks after surgery
measure: Change in Borg CR-10 dyspnea
timeFrame: Before surgery, 5th postoperative day and 2 weeks after surgery
measure: Change in EORTC QLQ-C30-LC13
timeFrame: Before surgery and 2 weeks after surgery
measure: Change in EQ-5D-5L
timeFrame: Before surgery and 2 weeks after surgery
measure: Change in Physical Activity Score- PAS
timeFrame: Before surgery and 2 weeks after surgery
measure: Change in numeric rang score for pain
timeFrame: Before surgery, 5th postoperative day and 2 weeks after surgery
measure: Change in numeric rang score for cough efficiency
timeFrame: 5th postoperative day and 2 weeks after surgery
Locations:
city: Aalborg
country: Denmark
facility: Department of Cardiothoracic Surgery, Aalborg Universityhospital
Study officials:
affiliation: Department of Occupational Therapy- and Physiotherapy, Aalborg Universityhospital
name: Barbara C Brocki, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brocki BC, Andreasen JJ, Langer D, Souza DS, Westerdahl E. Postoperative inspiratory muscle training in addition to breathing exercises and early mobilization improves oxygenation in high-risk patients after lung cancer surgery: a randomized controlled trial. Eur J Cardiothorac Surg. 2016 May;49(5):1483-91. doi: 10.1093/ejcts/ezv359. Epub 2015 Oct 20.