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

Phase 2
18 Years
Not Enrolling
Non Small Cell Lung Cancer

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Trial Information

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

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).

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

- number of patients who are adherent to the exercise intervention

Outcome Description:

Adherence is defined as: completion of at least two training sessions per week during minimum six weeks out of eight weeks of the intervention.

Outcome Time Frame:

8 months

Safety Issue:


Principal Investigator

Michael Thomas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg


Germany: Ethics Commission

Study ID:




Start Date:

March 2011

Completion Date:

December 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • exercise intervention
  • quality of life
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms