Lung Cancer
Conditions
Keywords
Pulmonary Rehabilitation, Lung Cancer Resection, Video-assisted thoracic surgery, Exercise tolerance, Quality of life
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.
Interventions
BEHAVIORALPulmonary Rehabilitation Program
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.
Sponsors
Universidade da Coruña
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Tolerance | Exercise tolerance 3 weeks after hospital discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | Quality of life 3 weeks after surgery | 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). |
| Upper Body Strength | 3 weeks 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. |
| Lower Body Strength | 3 weeks 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. |
Countries
Spain
Participant flow
Pre-assignment details
During the study period, 40 patients were recruited (20 per arm) but only 12 patients in the control group and 10 patients in the rehabilitation group were included in the analysis due to losses in follow-up
Participants by arm
| Arm | Count |
|---|---|
| Control Group | 12 |
| Rehabilitation Group | 10 |
| Total | 22 |
Baseline characteristics
| Characteristic | Rehabilitation Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Continuous | 70.9 years STANDARD_DEVIATION 6.1 | 69.4 years STANDARD_DEVIATION 9.4 | 70.1 years STANDARD_DEVIATION 7.9 |
| Region of Enrollment Spain | 10 participants | 12 participants | 22 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Exercise tolerance 3 weeks after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation Group | Exercise Tolerance | 459.7 Seconds | Standard Deviation 264.7 |
| Control Group | Exercise Tolerance | 341 Seconds | Standard Deviation 216.3 |
Primary
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.
Time frame: Exercise tolerance 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation Group | Exercise Tolerance | 560.3 Seconds | Standard Deviation 273.3 |
| Control Group | Exercise Tolerance | 271.5 Seconds | Standard Deviation 95 |
Secondary
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).
Time frame: Quality of life 3 weeks after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation Group | Health-Related Quality of Life | 38 units on a scale | Standard Deviation 8.6 |
| Control Group | Health-Related Quality of Life | 42.1 units on a scale | Standard Deviation 8.4 |
Secondary
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).
Time frame: Quality of life post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation Group | Health-Related Quality of Life | 45.8 units on a scale | Standard Deviation 5.8 |
| Control Group | Health-Related Quality of Life | 44.7 units on a scale | Standard Deviation 7.6 |
Secondary
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.
Time frame: 3 months post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation Group | Lower Body Strength | 11.5 Repetitions | Standard Deviation 2.55 |
| Control Group | Lower Body Strength | 14.9 Repetitions | Standard Deviation 5.6 |
Secondary
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.
Time frame: 3 weeks post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation Group | Lower Body Strength | 13.2 Repetitions | Standard Deviation 5.86 |
| Control Group | Lower Body Strength | 12.2 Repetitions | Standard Deviation 5.05 |
Secondary
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.
Time frame: 3 weeks post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation Group | Upper Body Strength | 17 Repetitions | Standard Deviation 3.4 |
| Control Group | Upper Body Strength | 17 Repetitions | Standard Deviation 3.2 |
Secondary
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.
Time frame: 3 months post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation Group | Upper Body Strength | 16.1 Repetitions | Standard Deviation 3.1 |
| Control Group | Upper Body Strength | 16 Repetitions | Standard Deviation 3.1 |