To Determine if a Lower Extremity Strengthening Program Improve Quadriceps Muscle Strength (Resistance)

This study is currently recruiting participants.

Verified December 2012 by University of Chicago

Sponsor:

Information provided by (Responsible Party):

Edward Garrity, University of Chicago

ClinicalTrials.gov Identifier:

NCT01080703

First received: March 2, 2010

Last updated: December 13, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 2, 2010

Last Updated Date

December 13, 2012

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Quadriceps Strength [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Quadriceps Strength will be assessed at initial evaluation and subsequently every two weeks for 10 weeks. Testing will be done at 30, 60 and 90 degrees of knee flexion using hand held dynamometer. The six miute walk test is also used as a primary outcomes to assess endurance. It will be done at initial evaluation, 5 weeks and 10 weeks.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01080703 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of Life Survey [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

The St. George Respiratory Questionnaire will be used to assess quality of life at initial evaluation and at 10 weeks (completion of program).

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

To Determine if a Lower Extremity Strengthening Program Improve Quadriceps Muscle Strength

Official Title ^ICMJE

Does The Lower Extremity Resistance Program Improve Quadriceps Strength, Endurance, And Quality Life In Pre-Lung Transplant Patients?

Brief Summary

The purpose of this study is to determine if a lower extremity strengthening program as part of pulmonary rehabilitation will improve quadriceps muscle strength, endurance and functional status as well as overall quality of life.

Hypothesis:

Lower extremity resistance training as part of a pulmonary rehabilitation program will improve quadriceps strength, endurance and functional capacity.
Lower extremity resistance training as part of a pulmonary rehabilitation program will improve quality of life in patients awaiting lung transplant.

Detailed Description

Objectives:

To determine if a lower extremity strengthening program as part of pulmonary rehabilitation is effective at increasing quadriceps strength when measured with a hand held dynamometer.
To determine the effectiveness of a lower extremity strengthening program as part of pulmonary rehabilitation for improving endurance and functional capacity as measured by the six minute walk test.
To determine if the lower extremity strengthening program as part of pulmonary rehabilitation improves overall quality of life as measured by the St. George's Respiratory Questionnaire.
To provide a basic framework for a larger randomized control study evaluating if a lower extremity strengthening program as part of a pulmonary rehabilitation program is more effective than a pulmonary rehabilitation program alone at improving quadriceps strength, endurance, and functional level.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Disease

Intervention ^ICMJE

Other: Exercise

Lower extremity resistance exercises and aerobic exercises 3 times a week in 10 week pulmonary rehabilitation program prior to lung transplant.

Study Arm (s)

Not Provided

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients preparing for lung transplant
Diagnoses included are: Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Cystic Fibrosis, or Bronchiectasis

Exclusion Criteria:

Primary Pulmonary Hypertension
Multi-organ transplant patients
Re-transplant patients
Patients requiring intubation greater than or equal to 7 days prior to transplant
Any orthopedic condition which will prevent from participation in a lower extremity strengthening program

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mieczyslawa Franczyk, PT, PhD	773-702-6891	mieczyslawa.franczyk@uchospitals.edu
Contact: Laura B Friedman, MS,PT	773-702-6891	laura.friedman@uchospitals.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01080703

Other Study ID Numbers ^ICMJE

10-076-B, PULMONARY

Has Data Monitoring Committee

Responsible Party

Edward Garrity, University of Chicago

Study Sponsor ^ICMJE

University of Chicago

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Edward R Garrity, MD

University of Chicago

Information Provided By

University of Chicago

Verification Date

December 2012

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

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