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

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ClinicalTrials.gov Identifier: NCT01793155
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : January 21, 2015
Sponsor:
Collaborators:
Region Örebro County
Örebro University, Sweden
KU Leuven
Information provided by (Responsible Party):
Barbara C. Brocki, Aalborg University Hospital

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

Condition or disease Intervention/treatment Phase
Lung Cancer Surgery Other: Inspiratory muscle training Other: Placebo comparator: standard physiotherapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Respiratory Muscle Strength, Functional Capacity and Subjective Outcome - Effects of Inspiratory Muscle Training After Lung Cancer Surgery, a Randomized Controlled Trial
Study Start Date : November 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Name: 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




Primary Outcome Measures :
  1. Change in inspiratory muscle strength [ Time Frame: Before surgery, 5.postoperative day, 2 weeks after surgery ]
    Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery


Secondary Outcome Measures :
  1. Change in expiratory muscle strength [ Time Frame: Before surgery, 5 th postoperative day and 2 weeks after surgery ]
    Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery

  2. Incidence of postoperative pulmonary complications [ Time Frame: 2 weeks after surgery ]

Other Outcome Measures:
  1. Change in walking distance, 6 minute [ Time Frame: before surgery, 5th postoperative day and 2 weeks after surgery ]
    Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery

  2. Change in spirometry values(FVC, FEV1) [ Time Frame: before surgery, 5th day, 2 weeks after surgery ]
    Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery

  3. Change in Borg CR-10 dyspnea [ Time Frame: Before surgery, 5th postoperative day and 2 weeks after surgery ]
    Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery

  4. Change in EORTC QLQ-C30-LC13 [ Time Frame: Before surgery and 2 weeks after surgery ]
  5. Change in EQ-5D-5L [ Time Frame: Before surgery and 2 weeks after surgery ]
  6. Change in Physical Activity Score- PAS [ Time Frame: Before surgery and 2 weeks after surgery ]
  7. Change in numeric rang score for pain [ Time Frame: Before surgery, 5th postoperative day and 2 weeks after surgery ]
    Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery

  8. Change in numeric rang score for cough efficiency [ Time Frame: 5th postoperative day and 2 weeks after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793155


Locations
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Denmark
Department of Cardiothoracic Surgery, Aalborg Universityhospital
Aalborg, Denmark, 9100
Sponsors and Collaborators
Aalborg University Hospital
Region Örebro County
Örebro University, Sweden
KU Leuven
Investigators
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Principal Investigator: Barbara C Brocki, PT Department of Occupational Therapy- and Physiotherapy, Aalborg Universityhospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Barbara C. Brocki, Specialist physiotherapist, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT01793155     History of Changes
Other Study ID Numbers: AAUH 01
N-201220027 ( Other Identifier: The Research Ethics Committee in Denmark )
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by Barbara C. Brocki, Aalborg University Hospital:
Lung cancer surgery
Inspiratory muscle training
Postoperative pulmonary complications
Functional outcomes
Health related quality of life
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Aspiration
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes