Exercise Study in Patients With Lung Cancer
POSITIVE
Pilot Study to Establish an Exercise Intervention in Patients With Lung Cancer
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedApril 20, 2012
April 1, 2012
7 months
April 5, 2012
April 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
- 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
Secondary Outcomes (2)
- effects of the exercise intervention on psychological symptoms (e.g. quality of life)
8 months
- effects of the exercise intervention on physical symptoms (muscle strength and endurance)
8 months
Study Arms (1)
exercise intervention
EXPERIMENTALPts 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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- acute infection
- immobility \> 2 days
- severe neurological impairment
- severe cardiac impairment
- severe pulmonal impairment
- severe renal impairment
- acute bleedings
- alcohol-/drug-abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- German Cancer Research Centerlead
- Heidelberg Universitycollaborator
Study Sites (1)
Thoracic Oncology Clinic for Thoracic Diseases
Heidelberg, 69126, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Thomas, MD
Heidelberg University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 20, 2012
Study Start
March 1, 2011
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
April 20, 2012
Record last verified: 2012-04