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Pulmonary Resection And Intensive Rehabilitation (PUREAIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02405273
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Ministry of Health, Italy
Information provided by (Responsible Party):
SARATENCONI, Arcispedale Santa Maria Nuova-IRCCS

Brief Summary:

Lung cancer is the leading cause of cancer death in males, and is increasing in females. Up to 73% of affected patients present with Chronic Obstructive Pulmonary Disease (COPD). Most lung cancer patients have an average survival of about 8 months from diagnosis. Lobectomy for initial stages has demonstrated higher survival rates, but only 15% to 25% are surgical candidates; unfortunately, cardiopulmonary impairment mainly due to coexisting COPD reduces this number and patients undergo medical treatment or marginal lung resection, with minor functional impact but possible ineffective control of disease.

Furthermore, COPD is associated with increased postoperative morbidity and mortality, longer in-hospital stay, need for additional treatments, and a rise in sanitary costs.

The investigators planned a randomised trial on surgical candidates to assess the effect of comprehensive pulmonary rehabilitation on functional and surgical outcomes, functioning, and Quality of Life (QoL).


Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Pulmonary Rehabilitation Procedure: Standard care Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Early Pulmonary Rehabilitation and Long-term Exercise on Functioning, Quality of Life and Postoperative Outcome in Lung Cancer Patients
Actual Study Start Date : April 2015
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Interventional Group
Pulmonary rehabilitation
Procedure: Pulmonary Rehabilitation
The Intervention Group (IG) will receive an overall rehabilitation treatment based on 10 sessions of pre-operative outpatient PR, early inpatient post-operative PR, and long-term exercise beginning 1 month after surgery and lasting for 15 sessions

Active Comparator: Control Group
Standard Care
Procedure: Standard care
Control Group (CG) will receive Standard Care (SC) based upon physiatrist counselling the day before surgery and early inpatient post-operative PR.




Primary Outcome Measures :
  1. Change in 6 Minutes Walking Test [ Time Frame: Baseline, Preoperative, 1 month, 6 month ]
    6MWT


Secondary Outcome Measures :
  1. Change in Pulmonary Function Tests [ Time Frame: Baseline, Preoperative, 1 month, 6 months ]
    PFT


Other Outcome Measures:
  1. Change of the rate of lobar resection in borderline patients [ Time Frame: Baseline, Postoperative ]
    Number of lobar resection recorded

  2. Change of the rate of postoperative complications [ Time Frame: Baseline, Postoperaive, 1 month ]
    Number of postoperative complications recorded

  3. Change in Quality of life [ Time Frame: Baseline, 6 months ]
    SF12 questionnaire

  4. Change in pain perception [ Time Frame: Baseline, 1 month, 6 months ]
    NRS questionnaire

  5. Change in the level of depression [ Time Frame: Baseline, postoperative, 6 months ]
    HADS questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stage 1 to 2B diagnosed or suspected NSCLC in operable patients

Exclusion Criteria:

  • unresectable disease, N2 disease requiring induction or postoperative chemotherapy
  • patients unfit for physical exercise requested by rehabilitation and assessments

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): NCT02405273


Locations
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Italy
Arcispedale_SMN
Reggio Emilia, RE, Italy, 42123
Arcispedale_SMN
Reggio Emilia, Italy, 42123
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Ministry of Health, Italy
Investigators
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Principal Investigator: Sara Tenconi, Dr Arcispedale Santa Maria Nuova-IRCCS
Study Director: Stefania Fugazzaro, Dr Arcispedale Santa Maria Nuova-IRCCS
Study Chair: Cristian Rapicetta, Dr Arcispedale Santa Maria Nuova-IRCCS
Study Chair: Roberto Piro, Dr Arcispedale Santa Maria Nuova-IRCCS
Study Chair: Besa Kopliku, Dr Arcispedale Santa Maria Nuova-IRCCS
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SARATENCONI, Dr, Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT02405273    
Other Study ID Numbers: GR-2011-02351711
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by SARATENCONI, Arcispedale Santa Maria Nuova-IRCCS:
Lung Cancer
Surgery
COPD
Rehabilitation
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases