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

Phase 2
18 Years
Open (Enrolling)
Lung Cancer, Surgery

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Trial Information

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

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

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.

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Change in inspiratory muscle strength

Outcome Description:

Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery

Outcome Time Frame:

Before surgery, 5.postoperative day, 2 weeks after surgery

Safety Issue:


Principal Investigator

Barbara C Brocki, PT

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Occupational Therapy- and Physiotherapy, Aalborg Universityhospital


Denmark: Danish Dataprotection Agency

Study ID:




Start Date:

November 2012

Completion Date:

July 2014

Related Keywords:

  • Lung Cancer
  • Surgery
  • Lung cancer surgery
  • Inspiratory muscle training
  • Postoperative pulmonary complications
  • Functional outcomes
  • Health related quality of life
  • Respiratory Aspiration
  • Lung Neoplasms