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

Sponsor

Aalborg University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01793155

Collaborator

Region Örebro County (Other), Örebro University, Sweden (Other), KU Leuven (Other)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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

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.

Study Design

Study Type:

Interventional

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 :

Nov 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in inspiratory muscle strength [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

Change in expiratory muscle strength [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
Incidence of postoperative pulmonary complications [2 weeks after surgery]

Other Outcome Measures

Change in walking distance, 6 minute [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
Change in spirometry values(FVC, FEV1) [before surgery, 5th day, 2 weeks after surgery]
Change from baseline to 5th postoperative day Change from baseline to 2 weeks after surgery
Change in Borg CR-10 dyspnea [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
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 [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
Change in numeric rang score for cough efficiency [5th postoperative day and 2 weeks after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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