Back to resultsEffectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pulmonary Rehabilitation Program
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Pulmonary Rehabilitation, Lung Cancer Resection, Video-assisted thoracic surgery, Exercise tolerance, Quality of life
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.
Sites / Locations
- Complejo Hospitalario Universitario A Coruña
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rehabilitation Group
Control Group
Arm Description
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
Outcomes
Primary Outcome Measures
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
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
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).
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).
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.
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.
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.
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.
Full Information
NCT ID
NCT01963923
First Posted
October 10, 2013
Last Updated
April 18, 2020
Sponsor
Universidade da Coruña
1. Study Identification
Unique Protocol Identification Number
NCT01963923
Brief Title
Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Coruña
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Pulmonary Rehabilitation, Lung Cancer Resection, Video-assisted thoracic surgery, Exercise tolerance, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation Group
Arm Type
Experimental
Arm Description
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary Rehabilitation Program
Other Intervention Name(s)
Endurance training, Strenght training, Incentive Spirometry
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise Tolerance
Description
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.
Time Frame
Exercise tolerance 3 weeks after hospital discharge
Title
Exercise Tolerance
Description
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.
Time Frame
Exercise tolerance 3 months after surgery
Secondary Outcome Measure Information:
Title
Health-Related Quality of Life
Description
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).
Time Frame
Quality of life 3 weeks after surgery
Title
Health-Related Quality of Life
Description
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).
Time Frame
Quality of life post-surgery
Title
Upper Body Strength
Description
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.
Time Frame
3 weeks post-surgery
Title
Upper Body Strength
Description
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.
Time Frame
3 months post-surgery
Title
Lower Body Strength
Description
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.
Time Frame
3 weeks post-surgery
Title
Lower Body Strength
Description
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.
Time Frame
3 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Complejo Hospitalario Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
28730888
Citation
Sebio Garcia R, Yanez-Brage MI, Gimenez Moolhuyzen E, Salorio Riobo M, Lista Paz A, Borro Mate JM. Preoperative exercise training prevents functional decline after lung resection surgery: a randomized, single-blind controlled trial. Clin Rehabil. 2017 Aug;31(8):1057-1067. doi: 10.1177/0269215516684179. Epub 2016 Dec 20.
Results Reference
derived
Learn more about this trial
Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection
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