An interventional study of Pulmonary Rehabilitation Program in Lung Cancer, sponsored by Universidade da Coruña. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-01.
Sponsored by Universidade da Coruña · Not applicable, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Universidade da Coruña is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program
Behavioral: Pulmonary Rehabilitation Program
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
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.
Also known as: Endurance training, Strenght training, Incentive Spirometry
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
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
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
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
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
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
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
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
| Milestone | Control Group | Rehabilitation Group |
|---|---|---|
| Started | 20 | 20 |
| Completed | 12 | 10 |
| Not completed | 8 | 10 |
| Milestone | Control Group | Rehabilitation Group |
|---|---|---|
| Started | 12 | 10 |
| Completed | 10 | 9 |
| Not completed | 2 | 1 |
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.
| Seconds | Rehabilitation Group | Control Group |
|---|---|---|
| Exercise Tolerance | 459.7 ± 264.7 | 341 ± 216.3 |
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.
| Seconds | Rehabilitation Group | Control Group |
|---|---|---|
| Exercise Tolerance | 560.3 ± 273.3 | 271.5 ± 95 |
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).
| units on a scale | Rehabilitation Group | Control Group |
|---|---|---|
| Health-Related Quality of Life | 38 ± 8.6 | 42.1 ± 8.4 |
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).
| units on a scale | Rehabilitation Group | Control Group |
|---|---|---|
| Health-Related Quality of Life | 45.8 ± 5.8 | 44.7 ± 7.6 |
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.
| Repetitions | Control Group | Rehabilitation Group |
|---|---|---|
| Upper Body Strength | 17 ± 3.4 | 17 ± 3.2 |
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.
| Repetitions | Control Group | Rehabilitation Group |
|---|---|---|
| Upper Body Strength | 16.1 ± 3.1 | 16 ± 3.1 |
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.
| Repetitions | Control Group | Rehabilitation Group |
|---|---|---|
| Lower Body Strength | 13.2 ± 5.86 | 12.2 ± 5.05 |
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.
| Repetitions | Control Group | Rehabilitation Group |
|---|---|---|
| Lower Body Strength | 11.5 ± 2.55 | 14.9 ± 5.6 |
Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rehabilitation Group | — | 0/20 (0%) | 0/20 (0%) |
| Control Group | — | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Control Group | Rehabilitation Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 2 | 6 |
| >=65 years | 8 | 8 | 16 |
| Age, Continuous(years) | Control Group | Rehabilitation Group | Total |
|---|---|---|---|
| Mean | 69.4 ± 9.4 | 70.9 ± 6.1 | 70.1 ± 7.9 |
| Sex: Female, Male(Participants) | Control Group | Rehabilitation Group | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 11 | 8 | 19 |
| Region of Enrollment(participants) | Control Group | Rehabilitation Group | Total |
|---|---|---|---|
| Spain | 12 | 10 | 22 |
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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