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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
  Purpose

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:

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

Condition Intervention
Pulmonary Disease
 Other: Exercise

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does The Lower Extremity Resistance Program Improve Quadriceps Strength, Endurance, And Quality Life In Pre-Lung Transplant Patients?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 15
Study Start Date: March 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Exercise
    Lower extremity resistance exercises and aerobic exercises 3 times a week in 10 week pulmonary rehabilitation program prior to lung transplant.
Detailed Description:

Objectives:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080703

Contacts
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

Locations
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Mieczyslawa Franczyk, PhD     773-702-0577     mieczyslawa.franczyk@uchospitals.edu    
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Edward R Garrity, MD University of Chicago
  More Information

No publications provided

Responsible Party: Edward Garrity, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01080703     History of Changes
Other Study ID Numbers: 10-076-B, PULMONARY
Study First Received: March 2, 2010
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Lung Transplant
Quadriceps Strength
Quality of Life
Patients with pulmonary disease awaiting lung transplant.

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013