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

Study Overview
=================
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.

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

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: Pulmonary Rehabilitation Program


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation Group<br>The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program | Behavioral: Pulmonary Rehabilitation Program<br>* 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.<br>* Other names: Incentive Spirometry;|
| No Intervention: Control Group<br>The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians. | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related Quality of Life | Health-Related Quality of Life measured with the 36-Item Short-Form Health Survey Version 2 (SF-36) three weeks 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). | Quality of life 3 weeks after surgery | 
| Health-Related Quality of Life | 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). | Quality of life post-surgery | 
| Upper Body Strength | 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. | 3 weeks post-surgery | 
| Upper Body Strength | 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. | 3 months post-surgery | 
| Lower Body Strength | 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. | 3 weeks post-surgery | 
| Lower Body Strength | 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. | 3 months post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Rehabilitation, Lung Cancer Resection, Video-assisted thoracic surgery, Exercise tolerance, Quality of life