Exercise Study in Patients With Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

— POSITIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581346
• Other study ID #: POSITIVE_II
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2012
• Last updated: April 18, 2012
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: German Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	Thoracic Oncology Clinic for Thoracic Diseases	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
German Cancer Research Center	Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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
Secondary	- 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	Yes
Secondary	- 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	Yes