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Purpose The purpose of the PROLUCA study is to investigate the efficacy of early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer, with focus on exercise training.
Design/Methods
One hundred and twenty-eight (n=128) participants (64 patients/study arm) with Non-Small Cell Lung Cancer (NSCLC), stage I-IIIa, referred for surgery, will be randomized to one of the following two groups:
The primary study endpoint is Maximal oxygen uptake measured by a VO2peak test (direct measurement) Secondary endpoints include: Six minutes walk distance (6MWD), One-repetition-maximum (1RM) Patient-reported outcomes (PROs) on health related quality of life, fatigue, depression, lifestyle, postoperative complications, hospitalization time, sick leave, work status and survival.
Results The results of PROLUCA will identify the optimal timing of postoperative rehabilitation in NSCLC patients with focus on increasing physical capacity and health related quality of life and reducing the side effects from the treatment of the cancer disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early initiated rehabilitation | Experimental | A supervised 12-week rehabilitation program, initiated two weeks post surgery, containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too. |
|
| late initiated rehabilitation | Active Comparator | A supervised 12-week rehabilitation program, initiated 14 weeks post surgery, containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation | Behavioral | The postoperative intervention are the same in both intervention groups and consists of a supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.The postoperative physical exercise consists of an individually prepared supervised strength exercise - and a group-based cardiovascular exercise twice a week (60 minutes/session) on non-consecutive days for 12 weeks, a total of 24 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| A change in maximum oxygen consumption | A change in maximum oxygen consumption from baseline to post interventon, measured by a VO2peak, evaluated by an incremental test using an electromagnetically braked cycle ergometer | A change in maximum oxygen consumption from baseline to post intervention (for group one, the experimental group, it is approximately 14 weeks after the operation and for group two it is approximately 26 weeks after the operation) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported outcomes | EORTC QLQ-C30, EORTC-LC13, FACT-L, SF-36, HADS, The distress thermometer, MSPSS, PAS2 | Baseline, post intervention, follow-up at 26 and 52 weeks after surgery |
| Six minutes walk distance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper H. Pedersen, MD, MrDSci | Rigshospitalet, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen Centre for Cancer and Health | Copenhagen | Capital Region of Denmark | DK-2200 | Denmark |
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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 |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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|
|
| Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery |
| Lung capacity | Spirometry | Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery |
| Muscle strength chest and leg press | one repetition maximum | Baseline, post intervention, follow-up at 26 and 52 weeks after surgery |
| A change in maximum oxygen consumption | measured by a VO2peak, evaluated by an incremental test using an electromagnetically braked cycle ergometer | A change in maximum oxygen consumption from baseline to 52 weeks after operation |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |