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Trial record 16 of 362 for:    pulmonary rehabilitation

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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 20, 2014