Feasibility of Exercise With Post-Op Lung Cancer Patients
Determining the Feasibility of Post-Operative Training for Patients Diagnosed With Non-Small Cell Lung Cancer
1 other identifier
interventional
21
1 country
1
Brief Summary
Primary Objective: To examine the effects of an exercise training program on cardiopulmonary fitness in early-stage postoperative non-small cell lung cancer patients undergoing adjuvant chemotherapy Secondary Objectives: Determine patients' adherence levels to such a program during adjuvant chemotherapy Explore the effects of exercise training on treatment compliance and toxicity, and quality of life. To explore the effects of exercise training on markers of inflammation (e.g., c-reactive protein, immune response) in patients undergoing adjuvant chemotherapy for early-stage non-small cell lung cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable nonsmall-cell-lung-cancer
Started Mar 2006
Shorter than P25 for not_applicable nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 27, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedOctober 28, 2013
October 1, 2013
1.5 years
February 27, 2008
October 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ECG stress test
8 weeks, 16 weeks
Secondary Outcomes (4)
Safety
8 weeks, 16 weeks
adherence levels
8 and 16 weeks
Treatment compliance and toxicity, and quality of life
8 and 16 weeks
Inflammation
8 and 16 weeks
Interventions
Upright bike intervention for post-surgical lung cancer survivors.
Eligibility Criteria
You may qualify if:
- Legal age (\>18 years old)
- Absence of contraindications to chemotherapy
- Ability to read and understand English
- Signed informed consent prior to the initiation of study procedures
- Primary attending oncologist approval.
You may not qualify if:
- Acute myocardial infarction (3-5 days)
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- Syncope
- Acute endocarditis
- Acute myocarditis or pericarditis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction
- Thrombosis of lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Room air desaturation at rest ≤85%
- Respiratory failure
- Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Lance Armstrong Foundationcollaborator
Study Sites (1)
Duke University Health System Preston Robert Tisch Brain Tumor Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lee Jones, PhD
Duke Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2008
First Posted
March 14, 2008
Study Start
March 1, 2006
Primary Completion
September 1, 2007
Study Completion
March 1, 2008
Last Updated
October 28, 2013
Record last verified: 2013-10