Exercise Study in Patients With Lung Cancer

Study Overview
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Brief Summary
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In the course of their disease patients with Non small cell lung cancer (NSCLC) often experience impaired psychological and physical functioning resulting in a reduced quality of life (QoL). The aim of the study is to explore the feasibility and the effects of an eight weeks combined muscle strength and endurance training on physical capacity and QoL.

Detailed Description
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In this open, prospective, single center study 40 patients (pts) with NSCLC undergoing adjuvant or palliative chemo-/ or radiotherapy are enrolled. Physical status is assessed by using the 6 Minute Walk Test (6MWT) for endurance and by using the Handheld Dynamometer (HHDM) for strength (flexion and extension of elbow, hip and knee). Psychological performance is measured by standardized questionnaires (MFI, FACT-L, PHQ - 9). Data are collected at baseline (T0) and after the 8 weeks sports intervention (T1). Pts are instructed to train at least 5 times/ week in the inpatient setting. After discharge pts are instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. Feasibility is defined as an adherence of two trainings per week during at least 6 weeks (out of 8 weeks of the intervention).

Official Title
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Pilot Study to Establish an Exercise Intervention in Patients With Lung Cancer

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Other: Exercise intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients histological confirmed diagnosis of Non small cell lung cancer (NSCLC) current treatment: chemo-and/or radiotherapy age > 18y Body Mass Index (BMI) > 18 written informed consent Exclusion Criteria: acute infection immobility > 2 days severe neurological impairment severe cardiac impairment severe pulmonal impairment severe renal impairment acute bleedings alcohol-/drug-abuse

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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise intervention<br>Pts were instructed to train at least 5 times/ week in the inpatient setting. After discharge pts were instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. | Other: Exercise intervention<br>* Pts were instructed to train at least 5 times/ week in the inpatient setting. After discharge pts were instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - number of patients who are adherent to the exercise intervention | Adherence is defined as: completion of at least two training sessions per week during minimum six weeks out of eight weeks of the intervention. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - effects of the exercise intervention on psychological symptoms (e.g. quality of life) | Quality of life will be measured by the standardized and validated questionnaire FACT-L; | 8 months | 
| - effects of the exercise intervention on physical symptoms (muscle strength and endurance) | Muscle strength will be measured by hand held dynamometry and endurance by 6 Minute Walk Test | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, exercise intervention, quality of life