Exercise Study in Patients With Lung Cancer

NCT ID: NCT01581346

Last Updated: 2012-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-12-31

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).

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role collaborator

German Cancer Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

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Thoracic Oncology Clinic for Thoracic Diseases

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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POSITIVE_II

Identifier Type: -

Identifier Source: org_study_id

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