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

Primary Purpose

Lung Cancer, Surgery

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Inspiratory muscle training
Placebo comparator: standard physiotherapy
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring Lung cancer surgery, Inspiratory muscle training, Postoperative pulmonary complications, Functional outcomes, Health related quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiothoracic Surgery, Aalborg Universityhospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inspiratory muscle training

Standard physiotherapy

Arm Description

Inspiratory muscle training for two weeks following surgery

Breathing exercises, cough/hugh, advice on early and active mobilization

Outcomes

Primary Outcome Measures

Change in inspiratory muscle strength
Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery

Secondary Outcome Measures

Change in expiratory muscle strength
Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery
Incidence of postoperative pulmonary complications

Full Information

First Posted
February 13, 2013
Last Updated
January 19, 2015
Sponsor
Aalborg University Hospital
Collaborators
Region Örebro County, Örebro University, Sweden, KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01793155
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Region Örebro County, Örebro University, Sweden, KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Surgery
Keywords
Lung cancer surgery, Inspiratory muscle training, Postoperative pulmonary complications, Functional outcomes, Health related quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
Inspiratory muscle training for two weeks following surgery
Arm Title
Standard physiotherapy
Arm Type
Placebo Comparator
Arm Description
Breathing exercises, cough/hugh, advice on early and active mobilization
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Other Intervention Name(s)
IMT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo comparator: standard physiotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in inspiratory muscle strength
Description
Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery
Time Frame
Before surgery, 5.postoperative day, 2 weeks after surgery
Secondary Outcome Measure Information:
Title
Change in expiratory muscle strength
Description
Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery
Time Frame
Before surgery, 5 th postoperative day and 2 weeks after surgery
Title
Incidence of postoperative pulmonary complications
Time Frame
2 weeks after surgery
Other Pre-specified Outcome Measures:
Title
Change in walking distance, 6 minute
Description
Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery
Time Frame
before surgery, 5th postoperative day and 2 weeks after surgery
Title
Change in spirometry values(FVC, FEV1)
Description
Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery
Time Frame
before surgery, 5th day, 2 weeks after surgery
Title
Change in Borg CR-10 dyspnea
Description
Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery
Time Frame
Before surgery, 5th postoperative day and 2 weeks after surgery
Title
Change in EORTC QLQ-C30-LC13
Time Frame
Before surgery and 2 weeks after surgery
Title
Change in EQ-5D-5L
Time Frame
Before surgery and 2 weeks after surgery
Title
Change in Physical Activity Score- PAS
Time Frame
Before surgery and 2 weeks after surgery
Title
Change in numeric rang score for pain
Description
Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery
Time Frame
Before surgery, 5th postoperative day and 2 weeks after surgery
Title
Change in numeric rang score for cough efficiency
Time Frame
5th postoperative day and 2 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara C Brocki, PT
Organizational Affiliation
Department of Occupational Therapy- and Physiotherapy, Aalborg Universityhospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, Aalborg Universityhospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26489835
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.
Results Reference
derived

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

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