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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793155
• Other study ID #: AAUH 01
• Secondary ID: N-201220027
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2013
• Last updated: January 19, 2015
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Other:
• Inspiratory muscle training
Inspiratory muscle training, as a supplement to placebo comparator, starts the day before surgery and continues for two weeks after surgery. No sessions are performed on the surgery day. Each session consists of 2 sets of 30 inspirations with a pause between each set of 2 minutes. The target intensity before surgery is 30% of the measured MIP and starts at 15% after surgery. The intensity is incrementally increased by 2 cm H20 the first days after surgery. Patients grade their perceived exertion and register eventual adverse effects in a training diary.
• Placebo comparator: standard physiotherapy
Standard physiotherapy - preoperative instruction and postoperative breathing exercises using positive expiratory pressure device (PEP) 3x10 breathings hourly during daytime, cough/huff for mucus clearance purpose, advice on early and active mobilization

Locations

Country	Name	City	State
Denmark	Department of Cardiothoracic Surgery, Aalborg Universityhospital	Aalborg

Sponsors (4)

Lead Sponsor	Collaborator
Aalborg Universitetshospital	Katholieke Universiteit Leuven, Örebro University, Sweden, University Hospital Orebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in walking distance, 6 minute	Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery	before surgery, 5th postoperative day and 2 weeks after surgery	No
Other	Change in spirometry values(FVC, FEV1)	Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery	before surgery, 5th day, 2 weeks after surgery	No
Other	Change in Borg CR-10 dyspnea	Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery	Before surgery, 5th postoperative day and 2 weeks after surgery	No
Other	Change in EORTC QLQ-C30-LC13		Before surgery and 2 weeks after surgery	No
Other	Change in EQ-5D-5L		Before surgery and 2 weeks after surgery	No
Other	Change in Physical Activity Score- PAS		Before surgery and 2 weeks after surgery	No
Other	Change in numeric rang score for pain	Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery	Before surgery, 5th postoperative day and 2 weeks after surgery	No
Other	Change in numeric rang score for cough efficiency		5th postoperative day and 2 weeks after surgery	No
Primary	Change in inspiratory muscle strength	Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery	Before surgery, 5.postoperative day, 2 weeks after surgery	No
Secondary	Change in expiratory muscle strength	Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery	Before surgery, 5 th postoperative day and 2 weeks after surgery	No
Secondary	Incidence of postoperative pulmonary complications		2 weeks after surgery	No