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NCT Number: NCT01793155

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

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Surgery Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Cardiothoracic Surgery, Aalborg Universityhospital

Aalborg, 9100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

Other

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

Placebo comparator: standard physiotherapy

Other

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • KU Leuven
  • Region Örebro County
  • Örebro University, Sweden

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 15, 2013
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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