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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Behavioral: Pulmonary Rehabilitation Program

• Registration Number: NCT01963923
• Lead Sponsor: Universidade da Coruña

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-12
• Study First Posted: 2013-10-16
• Primary Completion: 2015-07
• Study Completion: 2015-10
• Results First Submitted: 2020-03-27
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-18
• Last Update Submitted: 2020-04-18
• Results First Posted: 2020-05-01
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation Group	Pulmonary Rehabilitation Program	The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program

Primary Outcome Measures

Name	Time	Method
Exercise Tolerance	Exercise tolerance 3 months after surgery	Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three months after hospital discharge in comparison with the control group.

Secondary Outcome Measures

Name	Time	Method
Lower Body Strength	3 months post-surgery	Lower body strength measured with the sit-to-stand Test. The test consist of counting the number of full stands from a chair that can be completed in 30 seconds with arms folded across chest.
Upper Body Strength	3 months post-surgery	Upper body strength measured with the Arm-Curl Test of the Senior Fitness Test. The test measures the number of curl-arm movements with a 2.27kg or a 3.61 kg dumbbell for women and men respectively during 30 seconds.
Health-Related Quality of Life	Quality of life post-surgery	Health-Related Quality of Life measured with the 36-Item Short-Form Health Survey Version 2 (SF-36) three months post-surgery. This scale is scored on a 0 - 100 scale, with higher scores referring to a better health-related quality of life. The scale compromises 8 subscales and two summaries (physial and mental).

Trial Locations

Locations (1)

Complejo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Spain