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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower extremity strengthening	Other: Exercise; Lower extremity resistance exercises and aerobic exercises 3 times a week in 10 week pulmonary rehabilitation program prior to lung transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	10 weeks

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Edward R Garrity, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 2, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (Estimate): March 4, 2010

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Quality of Life; Quadriceps Strength; Lung Transplant; Patients with pulmonary disease awaiting lung transplant.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 10-076-B; PULMONARY