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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-58-0015 | Registry Identifier | Danish Data Protection Agency |
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Due to low recruiment rate, the study design is chanced to a feasibility study
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| Name | Class |
|---|---|
| Centre for Integrated Rehabilitation of Cancer patients, CIRE, Denmark | UNKNOWN |
| Danish Cancer Society | OTHER |
| Novo Nordisk A/S | INDUSTRY |
| University of Copenhagen |
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Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer diseases are after all still complex and potentially lethal.
Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise to improve recovery after surgery in patients operated for lunge cancer with focus on physical capacity and quality of life.
Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for operation. Participation in this study is not possible if the participants by a doctor are advised not to do strenuous exercise.
What does the study involve? The intervention consists of a combination of (1) exercise before surgery and (2) exercise after surgery for lung cancer.
What interventions will be compared? A home-based post-operative exercise program, combined with exercise initiated two weeks after surgery, will be compared with usual care (exercise initiated six weeks after surgery).
Will all participants receive the same treatment?
By draw it is decided which of the 4 groups the participants will attend to in the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Experimental | Experimental | Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. |
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| 2. Experimental | Experimental | Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. |
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| 3. Experimental | Experimental | Exercise in a team initiated two weeks after surgery. |
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| 4. Usual care | Other | Exercise in a team initiated six weeks after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: 1. Experimental | Behavioral | Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum oxygen uptake (VO2peak) | VO2peak is evaluated by an incremental test using an electromagnetically braked cycle ergometer (Lode Corival Ergometer©). Inspired and expired gases are analyzed breath-by-breath by a metabolic cart (JAEGER MasterScreen CPX©). Subjects begin pedaling at seven watts and resistance increases after a predefined 10 watts ramp protocol until exhaustion or a symptom-limited VO2peak is achieved (pain, dizziness, anxiety etc.). | VO2peak is assessed at baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Six minute walk distance (6MWD) | baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery. | |
| Patient reported outcomes (PROs) | PROs will include health related quality of life, symptoms and side-effects, anxiety and depression, well-being, distress, lifestyle, sickness absence, work status, and social support. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper Holst Pedersen, MD, DrMSci | Department of Cardiothoracic Surgery RT | Study Chair |
| Jette Vibe-Petersen, MD | Copenhagen Centre for Cancer and Health | Study Director |
| Maja Schick Sommer, MHS | Copenhagen Centre for Cancer and Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen Centre for Cancer and Health | Copenhagen | Nørrebro | DK-2200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24898680 | Derived | Sommer MS, Trier K, Vibe-Petersen J, Missel M, Christensen M, Larsen KR, Langer SW, Hendriksen C, Clementsen P, Pedersen JH, Langberg H. Perioperative rehabilitation in operation for lung cancer (PROLUCA) - rationale and design. BMC Cancer. 2014 Jun 4;14:404. doi: 10.1186/1471-2407-14-404. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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| OTHER |
| Copenhagen Centre for Cancer and Health, Denmark. | UNKNOWN |
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| Experimental: 2. Experimental | Behavioral | Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Intervention consists of:
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| Experimental: 3. Experimental | Behavioral | Early postoperative exercise in a team initiated two weeks after surgery. Intervention consists of: Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM. |
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| Other: 4. Usual care | Behavioral | Exercise in a team initiated six weeks after surgery consisting 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 cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM. |
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| Baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery. |
| Pulmonary function | forced expiratory volume at one second | Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery. |
| D012140 |
| Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D001519 | Behavior |