Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT01080703
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2010-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Determine if a Lower Extremity Strengthening Program Improve Quadriceps Muscle Strength
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2010-03-02', 'studyFirstSubmitQcDate': '2010-03-02', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quadriceps Strength', 'timeFrame': '10 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Survey', 'timeFrame': '10 weeks', 'description': 'The St. George Respiratory Questionnaire will be used to assess quality of life at initial evaluation and at 10 weeks (completion of program).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung Transplant', 'Quadriceps Strength', 'Quality of Life', 'Patients with pulmonary disease awaiting lung transplant.'], 'conditions': ['Pulmonary Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nHypothesis:\n\n1. Lower extremity resistance training as part of a pulmonary rehabilitation program will improve quadriceps strength, endurance and functional capacity.\n2. Lower extremity resistance training as part of a pulmonary rehabilitation program will improve quality of life in patients awaiting lung transplant.', 'detailedDescription': "Objectives:\n\n1. 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.\n2. 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.\n3. 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.\n4. 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients preparing for lung transplant\n* Diagnoses included are: Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Cystic Fibrosis, or Bronchiectasis\n\nExclusion Criteria:\n\n* Primary Pulmonary Hypertension\n* Multi-organ transplant patients\n* Re-transplant patients\n* Patients requiring intubation greater than or equal to 7 days prior to transplant\n* Any orthopedic condition which will prevent from participation in a lower extremity strengthening program'}, 'identificationModule': {'nctId': 'NCT01080703', 'acronym': 'Resistance', 'briefTitle': 'To Determine if a Lower Extremity Strengthening Program Improve Quadriceps Muscle Strength', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Does The Lower Extremity Resistance Program Improve Quadriceps Strength, Endurance, And Quality Life In Pre-Lung Transplant Patients?', 'orgStudyIdInfo': {'id': '10-076-B'}, 'secondaryIdInfos': [{'id': 'PULMONARY'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lower extremity strengthening', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Lower extremity resistance exercises and aerobic exercises 3 times a week in 10 week pulmonary rehabilitation program prior to lung transplant.', 'armGroupLabels': ['Lower extremity strengthening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Edward R Garrity, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}