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).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
- 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
Yes
Michael Thomas, MD
Principal Investigator
University of Heidelberg
Germany: Ethics Commission
POSITIVE_II
NCT01581346
March 2011
December 2011
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