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Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection

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ClinicalTrials.gov Identifier: NCT01963923
Recruitment Status : Unknown
Verified October 2013 by Esther Gimenez Moolhuyzen, Hospital Juan Canalejo.
Recruitment status was:  Recruiting
First Posted : October 16, 2013
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Esther Gimenez Moolhuyzen, Hospital Juan Canalejo

Brief Summary:
The purpose of this study is to establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. The investigators hypothesized that a pulmonary rehabilitation program including both endurance and strength training may improve exercise tolerance and quality of life measured with a submaximal exercise test and a quality of life questionnaire respectively.

Condition or disease Intervention/treatment Phase
Lung Cancer Behavioral: Pulmonary Rehabilitation Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Exercise Tolerance and Quality of Life in Patients Awaiting Lung Resection by Video-assisted Thoracic Surgery
Study Start Date : October 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rehabilitation Group
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Behavioral: Pulmonary Rehabilitation Program
The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
Other Names:
  • Endurance training
  • Strenght training
  • Incentive Spirometry

No Intervention: Control Group
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.



Primary Outcome Measures :
  1. Exercise tolerance [ Time Frame: Exercise tolerance 3 days after hospital discharge ]
    Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three days after hospital discharge in comparison with the control group.


Secondary Outcome Measures :
  1. Exercise Tolerance [ Time Frame: Exercise tolerance post-rehabilitation; 1 - 2 days before surgery ]
    Maximum time sustained during constant-load cycle endurance measured three months after completing the rehabilitation program

  2. Exercise Tolerance [ Time Frame: Exercise tolerance post-rehabilitation; 1 - 2 days before surgery ]
    Maximal distance covered with the 6 minute walking test after rehabilitation program

  3. Exercise Tolerance [ Time Frame: Exercise tolerance post-surgery 3 days after hospital discharge ]
    Maximal distance covered with the 6 minute walking test 3 days after hospital discharge

  4. Exercise tolerance [ Time Frame: Exercise tolerance at 3 months follow-up ]
    Maximal distance covered with the 6 minute walking test at 3 months after surgery

  5. Quality of life [ Time Frame: Quality of life post-rehabilitation, 1 - 2 days prior surgery ]
    Quality of life measured with the 36-Item Short-Form Health Survey Version 2 after the rehabilitation program

  6. Quality of life [ Time Frame: Quality of life post-surgery, 3 days after hospital discharge ]
    Quality of life measured with the 36-Item Short-Form Health Survey Version 2 at day three after hospital discharge

  7. Quality of life [ Time Frame: Quality of life at 3 months follow-up ]
    Quality of life measured with the 36-Item Short-Form Health Survey Version 2 at three months after the surgery

  8. Functional capacity [ Time Frame: Functional capacity post-rehabilitation; 1 - 2 days before surgery ]
    Evaluation of the functional capacity with the curl-arm test and the stand to sit test after the rehabilitation program

  9. Functional capacity [ Time Frame: Functional capacity post-surgery, 3 days after hospital discharge ]
    Evaluation of the functional capacity with the curl-arm test and the stand to sit test 3 days from hospital discharge

  10. Functional capacity [ Time Frame: Functional capacity at 3 months follow-up ]
    Evaluation of the functional capacity with the curl-arm test and the stand to sit test 3 months after surgery

  11. Exercise Tolerance [ Time Frame: Exercise tolerance at 3 months follow-up ]
    Maximum sustained time during the constant-cycle endurance test at 3 months after surgery

  12. Exercise Endurance [ Time Frame: Exercise endurance at 3 months follow up ]
    Maximum time sustained during the constant-load cycle endurance test measured 3 months after surgery



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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:

  • Diagnosis confirmed or suspected of lung cancer (either primary or metastatic)
  • Be on the waiting list for lung resection by Video-assisted thoracic surgery
  • Present at least one of the next conditions: Forced Expiratory Volume in 1 second (FEV1)<80% of predicted and/or Body Mass Index > 30 or/and >80 years old and/or two or more comorbidities (Arterial Hypertension, Chronic Obstructive Pulmonary Disease, Coronary Disease, Diabetes, Renal Failure and/or cancer.
  • No smoking at the time of recruitment
  • Signed Informed Consent

Exclusion Criteria:

  • Chemotherapy or Radiotherapy in the previous 6 months before the Rehabilitation program.
  • Thoracotomies or pneumonectomies.

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): NCT01963923


Contacts
Contact: Raquel Sebio, PT +34981167000 ext 5816 raquel.sebio@udc.es

Locations
Spain
Complejo Hospitalario Universitario A Coruña Recruiting
A Coruña, Spain, 15006
Contact: Raquel Sebio, Physiotherapist    +35981167000 ext 5816    raquel.sebio@udc.es   
Principal Investigator: Esther Gimenez, Physiotherapist         
Sub-Investigator: Raquel Sebio, Physiotherapist         
Sub-Investigator: Marta Salorio, Physiotherapist         
Sponsors and Collaborators
Universidade da Coruña

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Esther Gimenez Moolhuyzen, Physiotherapist, Hospital Juan Canalejo
ClinicalTrials.gov Identifier: NCT01963923     History of Changes
Other Study ID Numbers: RCP-RSG-2011
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: December 20, 2013
Last Verified: October 2013

Keywords provided by Esther Gimenez Moolhuyzen, Hospital Juan Canalejo:
Pulmonary Rehabilitation
Lung Cancer Resection
Video-assisted thoracic surgery
Exercise tolerance
Quality of life