Pulmonary Resection And Intensive Rehabilitation

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).

Conditions

• Lung Cancer

Interventions

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

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.

Sponsors & Collaborators

• Ministry of Health, Italy

  collaborator OTHER_GOV

• Azienda USL Reggio Emilia - IRCCS

  lead OTHER_GOV

Principal Investigators

• Sara Tenconi, Dr · Azienda USL Reggio Emilia - IRCCS

• Stefania Fugazzaro, Dr · Azienda USL Reggio Emilia - IRCCS

• Cristian Rapicetta, Dr · Azienda USL Reggio Emilia - IRCCS

• Roberto Piro, Dr · Azienda USL Reggio Emilia - IRCCS

• Besa Kopliku, Dr · Azienda USL Reggio Emilia - IRCCS

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2019-06-30

Completion

2019-06-30

Countries

• Italy

Study Locations