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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation Group | Experimental | The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program |
|
| Control Group | No Intervention | The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Rehabilitation Program | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28730888 | Derived | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | |
| FG001 | Rehabilitation Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 Weeks Post-surgery |
| |||||||||||||
| 3 Months Post-surgery |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | |
| BG001 | Rehabilitation Group | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Seconds | Exercise tolerance 3 weeks after hospital discharge |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rehabilitation Group | The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program Pulmonary 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esther Gimenez Moolhuyzen | Complejo Hospitalario Universitario A Coruña | 679336288 | raquel.sebio@udc.es |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000076663 | Endurance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| 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 |
| NOT COMPLETED |
|
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.
|
|
| 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. | Posted | Mean | Standard Deviation | Seconds | Exercise tolerance 3 months after surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Quality of life 3 weeks after surgery |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Quality of life post-surgery |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Repetitions | 3 weeks post-surgery |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Repetitions | 3 months post-surgery |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Repetitions | 3 weeks post-surgery |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Repetitions | 3 months post-surgery |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control Group | The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians. | 0 | 20 | 0 | 20 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |