Resistance Training in Lung Cancer Patients on Chemotherapy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kristina Karvinen, East Carolina University

ClinicalTrials.gov Identifier:

NCT01130714

First received: January 6, 2010

Last updated: July 12, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 6, 2010

Last Updated Date

July 12, 2012

Start Date ^ICMJE

January 2010

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Systemic inflammation measured by c-reactive protein. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01130714 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Chemotherapy completion [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Resistance Training in Lung Cancer Patients on Chemotherapy

Official Title ^ICMJE

Effectiveness of a Resistance Training Program on Inflammatory Markers and Chemotherapy Completion in Lung Cancer Patients on Chemotherapy

Brief Summary

The purpose of this study is to examine the effectiveness of a resistance training program on reducing systemic inflammation and improving chemotherapy completion in lung cancer patients being treated with curative intent chemotherapy.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Inflammation
Lung Cancer

Intervention ^ICMJE

Behavioral: Exercise

Resistance training with resistance bands.

Study Arm (s)

Experimental: Resistance training
Group assigned to complete resistance training during duration of chemotherapy.

Intervention: Behavioral: Exercise
No Intervention: Control
Usual care.

Intervention: Behavioral: Exercise

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2012

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically diagnosed with lung cancer
Stage I, II, or III
Eligible for chemotherapy with curative intent
21 years of age or older
Approval to participate in study by treating oncologist or family physician

Exclusion Criteria:

Unstable cardiac disease
Untreated bone or brain metastases

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01130714

Other Study ID Numbers ^ICMJE

UMCIRB 09-0725

Has Data Monitoring Committee

Responsible Party

Kristina Karvinen, East Carolina University

Study Sponsor ^ICMJE

East Carolina University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kristina H Karvinen, PhD

East Carolina University

Information Provided By

East Carolina University

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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