NCT01080703

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

3.8 years

First QC Date

March 2, 2010

Last Update Submit

December 3, 2014

Conditions

Keywords

Lung TransplantQuadriceps StrengthQuality of LifePatients with pulmonary disease awaiting lung transplant.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of Life Survey

    10 weeks

Study Arms (1)

Lower extremity strengthening

EXPERIMENTAL
Other: Exercise

Interventions

Lower extremity resistance exercises and aerobic exercises 3 times a week in 10 week pulmonary rehabilitation program prior to lung transplant.

Lower extremity strengthening

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients preparing for lung transplant
  • Diagnoses included are: Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Cystic Fibrosis, or Bronchiectasis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Edward R Garrity, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 4, 2010

Study Start

March 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations