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

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

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

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Surgery
• Intervention / Treatment: Other: Inspiratory muscle training; Other: Placebo comparator: standard physiotherapy

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9100
    • Department of Cardiothoracic Surgery, Aalborg Universityhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory muscle training; Inspiratory muscle training for two weeks following surgery	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.; Other Names: IMT; Other: 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
Placebo Comparator: Standard physiotherapy; Breathing exercises, cough/hugh, advice on early and active mobilization	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of postoperative pulmonary complications		2 weeks after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Change in EORTC QLQ-C30-LC13		Before surgery and 2 weeks after surgery
Change in EQ-5D-5L		Before surgery and 2 weeks after surgery
Change in Physical Activity Score- PAS		Before surgery and 2 weeks after surgery
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
Change in numeric rang score for cough efficiency		5th postoperative day and 2 weeks after surgery

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: KU Leuven; Örebro University, Sweden; Region Örebro County
• Investigators: Principal Investigator: Barbara C Brocki, PT, Department of Occupational Therapy- and Physiotherapy, Aalborg Universityhospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: February 14, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 19, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Postoperative pulmonary complications; Inspiratory muscle training; Health related quality of life; Functional outcomes; Lung cancer surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Respiration Disorders; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Respiratory Aspiration
• Other Study ID Numbers: AAUH 01; N-201220027 (Other Identifier: The Research Ethics Committee in Denmark)