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

This study is currently recruiting participants.
Verified October 2013 by Universidade da Coruña
Sponsor:
Information provided by (Responsible Party):
Esther Gimenez Moolhuyzen, Hospital Juan Canalejo
ClinicalTrials.gov Identifier:
NCT01963923
First received: October 10, 2013
Last updated: December 19, 2013
Last verified: October 2013
  Purpose

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 Intervention
Lung Cancer
Behavioral: Pulmonary Rehabilitation Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Universidade da Coruña:

Primary Outcome Measures:
  • Exercise tolerance [ Time Frame: Exercise tolerance 3 days after hospital discharge ] [ Designated as safety issue: No ]
    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:
  • Exercise Tolerance [ Time Frame: Exercise tolerance post-rehabilitation; 1 - 2 days before surgery ] [ Designated as safety issue: No ]
    Maximum time sustained during constant-load cycle endurance measured three months after completing the rehabilitation program

  • Exercise Tolerance [ Time Frame: Exercise tolerance post-rehabilitation; 1 - 2 days before surgery ] [ Designated as safety issue: No ]
    Maximal distance covered with the 6 minute walking test after rehabilitation program

  • Exercise Tolerance [ Time Frame: Exercise tolerance post-surgery 3 days after hospital discharge ] [ Designated as safety issue: No ]
    Maximal distance covered with the 6 minute walking test 3 days after hospital discharge

  • Exercise tolerance [ Time Frame: Exercise tolerance at 3 months follow-up ] [ Designated as safety issue: No ]
    Maximal distance covered with the 6 minute walking test at 3 months after surgery

  • Quality of life [ Time Frame: Quality of life post-rehabilitation, 1 - 2 days prior surgery ] [ Designated as safety issue: No ]
    Quality of life measured with the 36-Item Short-Form Health Survey Version 2 after the rehabilitation program

  • Quality of life [ Time Frame: Quality of life post-surgery, 3 days after hospital discharge ] [ Designated as safety issue: No ]
    Quality of life measured with the 36-Item Short-Form Health Survey Version 2 at day three after hospital discharge

  • Quality of life [ Time Frame: Quality of life at 3 months follow-up ] [ Designated as safety issue: No ]
    Quality of life measured with the 36-Item Short-Form Health Survey Version 2 at three months after the surgery

  • Functional capacity [ Time Frame: Functional capacity post-rehabilitation; 1 - 2 days before surgery ] [ Designated as safety issue: No ]
    Evaluation of the functional capacity with the curl-arm test and the stand to sit test after the rehabilitation program

  • Functional capacity [ Time Frame: Functional capacity post-surgery, 3 days after hospital discharge ] [ Designated as safety issue: No ]
    Evaluation of the functional capacity with the curl-arm test and the stand to sit test 3 days from hospital discharge

  • Functional capacity [ Time Frame: Functional capacity at 3 months follow-up ] [ Designated as safety issue: No ]
    Evaluation of the functional capacity with the curl-arm test and the stand to sit test 3 months after surgery

  • Exercise Tolerance [ Time Frame: Exercise tolerance at 3 months follow-up ] [ Designated as safety issue: No ]
    Maximum sustained time during the constant-cycle endurance test at 3 months after surgery

  • Exercise Endurance [ Time Frame: Exercise endurance at 3 months follow up ] [ Designated as safety issue: No ]
    Maximum time sustained during the constant-load cycle endurance test measured 3 months after surgery


Estimated Enrollment: 22
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Esther Gimenez Moolhuyzen, Physiotherapist, Hospital Juan Canalejo
ClinicalTrials.gov Identifier: NCT01963923     History of Changes
Other Study ID Numbers: RCP-RSG-2011
Study First Received: October 10, 2013
Last Updated: December 19, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidade da Coruña:
Pulmonary Rehabilitation
Lung Cancer Resection
Video-assisted thoracic surgery
Exercise tolerance
Quality of life

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 20, 2014