Exercise Study in Patients With Lung Cancer

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Other: Exercise intervention

• Registration Number: NCT01581346
• Lead Sponsor: German Cancer Research Center

Brief Summary

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

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).

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2012-04
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-18
• Last Update Submitted: 2012-04-18
• Study First Posted: 2012-04-20
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• acute infection
• immobility > 2 days
• severe neurological impairment
• severe cardiac impairment
• severe pulmonal impairment
• severe renal impairment
• acute bleedings
• alcohol-/drug-abuse

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
exercise intervention	Exercise intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thoracic Oncology Clinic for Thoracic Diseases; 🇩🇪 Heidelberg, Germany