Multidisciplinary Rehabilitation After Cancer Pulmonis Operation

Study Overview
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Brief Summary
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The purpose of this investigation is to determine the effects of exercise training on quality of life and physical capacity, 3 months and 1 year after radical operation for pulmonary cancer.

Detailed Description
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Patients who are radically operated for pulmonary cancer report suffering from respiratory problems, mostly dyspnoea, 5 years after operation. Dyspnoea restricts their physical capability and leads to poorer physical, social and mental wellbeing. The effects of training programs on physical and mental wellbeing for cancer patients are well documented. Most of the studies are though performed on patients suffering from breast, colon and prostate cancer. There are only few studies addressing patients with pulmonary cancer. They are mostly focused on short term effects of exercise training on quality of life, with no control group included in the trials. These studies target patients after different forms for treatment, including surgery, chemotherapy and radiation. There is no data referring to quality of life of patients who are radically operated for pulmonary cancer. Comparison: multidisciplinary group intervention consisting of exercise training and dyspnoea counseling, 10 times, once a week, compared with one instruction in exercise training and dyspnoea counseling. Exercise training is given by a physiotherapist. Both groups receive in addition standard treatment, which is up to 3 counseling sessions with a nurse.

Official Title
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Multidisciplinary Rehabilitation After Cancer Pulmonis Operation - a Randomized Controlled Trial

Conditions
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Pulmonary Cancer

Intervention / Treatment
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* Other: physical exercise and dyspnoea counseling
* Other: home training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who are radically operated for pulmonary cancer at Aalbor Hospital, Aarhus University Hospital Exclusion Criteria: not radically operated cannot speak and read Danish cannot cooperate in tests due to poor mental health patients who undergo rehabilitation at other centres cannot perform walking test due to physical impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: supervised exercise training<br>Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training | Other: physical exercise and dyspnoea counseling<br>* Exercise training in group, 1 hour once a week for 10 weeks, based om aerobic exercises 60-80% of VO2 max (Borg 11-12), resistance training and dyspnea counseling. Participants are urge to exercise training for at least twice a week.<br>* Other names: training in groups;Other: home training<br>* one instruction in home based exercise training<br>* Other names: home based exercises;|
| Sham Comparator: one instruction on homebased exercises<br>One instruction on home based exercise training and dyspnea management | Other: home training<br>* one instruction in home based exercise training<br>* Other names: home based exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT |  | 4 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in selv reported quality of life and physical capacity 1 year after inclusion, measured by SF-36 and 6MWT |  | 1 year after inclusion | 
| Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC) |  | 4 months and 1 year after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary cancer, radically operated, exercise training, dyspnea counseling, quality of life, physical therapy