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

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT01080703
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 46.1
• Patients Per Site Per Month: 0.9

Study Details

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:

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 or Disease	Intervention/Treatment	Phase
Pulmonary Disease	Other: Exercise	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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?
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Quadriceps Strength [10 weeks]

   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

1. Quality of Life Survey [10 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The University of Chicago Medical Center	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT01080703
• Other Study ID Numbers: 10-076-B; PULMONARY
• First Posted: Mar 4, 2010
• Last Update Posted: Dec 4, 2014
• Last Verified: Dec 1, 2014

• 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

Study Results

No Results Posted as of Dec 4, 2014