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

Primary Purpose

Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease focused on measuring Lung Transplant, Quadriceps Strength, Quality of Life, Patients with pulmonary disease awaiting lung transplant.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Chicago Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lower extremity strengthening

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
March 2, 2010
Last Updated
December 3, 2014
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01080703
Brief Title
To Determine if a Lower Extremity Strengthening Program Improve Quadriceps Muscle Strength
Acronym
Resistance
Official Title
Does The Lower Extremity Resistance Program Improve Quadriceps Strength, Endurance, And Quality Life In Pre-Lung Transplant Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease
Keywords
Lung Transplant, Quadriceps Strength, Quality of Life, Patients with pulmonary disease awaiting lung transplant.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower extremity strengthening
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Lower extremity resistance exercises and aerobic exercises 3 times a week in 10 week pulmonary rehabilitation program prior to lung transplant.
Primary Outcome Measure Information:
Title
Quadriceps Strength
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Quality of Life Survey
Description
The St. George Respiratory Questionnaire will be used to assess quality of life at initial evaluation and at 10 weeks (completion of program).
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward R Garrity, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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