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

NCT01793155 | Completed Phase 2

• 2 other identifiers: AAUH 01N-201220027
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer; Surgery

Keywords

Lung cancer surgery; Inspiratory muscle training; Postoperative pulmonary complications; Functional outcomes; Health related quality of life

Outcome Measures

Primary Outcomes (1)

• Change in inspiratory muscle strength

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

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

Secondary Outcomes (2)

• Change in expiratory muscle strength

  Before surgery, 5 th postoperative day and 2 weeks after surgery

• Incidence of postoperative pulmonary complications

  2 weeks after surgery

Other Outcomes (8)

• Change in walking distance, 6 minute

  before surgery, 5th postoperative day and 2 weeks after surgery

• Change in spirometry values(FVC, FEV1)

  before surgery, 5th day, 2 weeks after surgery

• Change in Borg CR-10 dyspnea

  Before surgery, 5th postoperative day and 2 weeks after surgery

Study Arms (2)

Inspiratory muscle training

EXPERIMENTAL

Inspiratory muscle training for two weeks following surgery

Other: Inspiratory muscle training; Other: Placebo comparator: standard physiotherapy

Standard physiotherapy

PLACEBO COMPARATOR

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

Other: Placebo comparator: standard physiotherapy

Interventions

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.

Also known as: IMT

Inspiratory muscle training

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

Inspiratory muscle training; Standard physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Region Örebro County: collaborator
• Örebro University, Sweden: collaborator
• KU Leuven: collaborator

Study Sites (1)

Department of Cardiothoracic Surgery, Aalborg Universityhospital

Aalborg, 9100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 26489835 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Barbara C Brocki, PT

  Department of Occupational Therapy- and Physiotherapy, Aalborg Universityhospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist physiotherapist

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

DK (1)