Resistance Exercise Training For Radically Treated Respiratory Cancer

Study Overview
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Brief Summary
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The first part of the study is an observational part. In eligible patients with early stage respiratory cancer, the primary and secondary endpoints will be evaluated before and after their scheduled radical cancer therapy. The measured variables, include a blood sample, pulmonary function tests, level of dyspnea, exercise tests, measurement of body composition, respiratory and peripheral muscle force, health related quality of life and psychological status. Only registered participants having completed a radical treatment and having either less than 70% of the predicted normal value of the quadriceps force (QF) or a decrease of more than 10% predicted value of the QF between pre-and post radical treatment, will be allowed to participate to the second part of the study. These patients will then be randomized in three groups. Group A, the control group, will have the usual care and follow up according to clinical symptoms. Group B will be offered a conventional resistance training program (CRT), and group C, will be offered a whole body vibration resistance training (WBV) on the FITVIBE-platform. All previous variables will be measured after 6 and 12 weeks of training.

Official Title
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Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study

Conditions
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Respiratory Cancer

Intervention / Treatment
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* Other: Conventional resistance training
* Other: Whole body vibration resistance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with non-small cell or small cell lung cancer or mesothelioma candidate for radical treatment either by surgical resection with or without perioperative chemotherapy or by thoracic radiotherapy with or without chemotherapy Between 18 and 80 years of age Written informed consent Supplementary criteria for PART II: Treatment for their cancer considered radical either by surgical resection with or without perioperative chemotherapy or by thoracic radiotherapy with or without chemotherapy having less than 70% of the predicted normal value of the Quadriceps Force (QF) or a decrease of more than 10% predicted value of the QF between the baseline and post-radical therapy measurement of QF Post treatment assessment maximum 14 days after radical treatment or between 6th and 8th week after radical treatment if the latter consists only of surgical resection Exclusion Criteria: Patients presenting with one or more of the following will be excluded: Severe anemia (Hb below 8 g/dl) Fever (> 38°C) Cachexia (loss of more than 35% of premorbid weight) Severe cardiac, neurological and orthopedic co-morbidity interfering with exercise training. A pacemaker, hip, knee of shoulder prosthesis or recently introduced spirals, metal pens, bolts or plates Uncontrolled diabetes, epilepsy or migraine Uncontrolled vertebral diseases (osteoporotic or metastatic fractures, acute hernia, discopathy, spondylitis) Open wounds

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Control group | |
| Active Comparator: 2<br>Conventional resistance training program (CRT) | Other: Conventional resistance training<br>* Conventional resistance training program (CRT)<br>|
| Experimental: 3<br>Whole body vibration resistance training (WBV) on the FITVIBE-platform | Other: Whole body vibration resistance training<br>* Whole body vibration resistance training (WBV) on the FITVIBE-platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of 6MWD observed between pre-and post radical treatment |  | 12 weeks | 
| between post radical treatment and after a 12 week resistance training |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of the following variables: Muscle strength |  | 12 weeks | 
| Muscle mass |  | 12 weeks | 
| Body composition |  | 12 weeks | 
| Maximal exercise capacity |  | 12 weeks | 
| Muscle force |  | 12 weeks | 
| Quality of life |  | 12 weeks | 
| Anxiety and depression scores |  | 12 weeks | 
| Dyspnea scores |  | 12 weeks | 
| 6MWD |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients, radically, treated