Pulmonary DiseaseResistanceNCT01080703
To Determine if a Lower Extremity Strengthening Program Improve Quadriceps Muscle Strength
A study testing Exercise in people with Pulmonary Disease, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients preparing for lung transplant
- Diagnoses included are: Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Cystic Fibrosis, or Bronchiectasis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Pulmonary Disease
- Being tested
- Exercise
- Keywords
- Lung Transplant, Quadriceps Strength, Quality of Life, Patients with pulmonary disease awaiting lung transplant.
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Lower extremity resistance exercises and aerobic exercises 3 times a week in 10 week pulmonary rehabilitation program prior to lung transplant.
| Study group | Role | What they receive |
|---|---|---|
| Lower extremity strengthening | Experimental | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (1)
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).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward R Garrity, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080703
- Sponsor's protocol ID
- 10-076-B
- Other IDs
- PULMONARY
- Acronym
- Resistance
- Status last verified
- Dec 2014
- First submitted
- 2 Mar 2010
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does The Lower Extremity Resistance Program Improve Quadriceps Strength, Endurance, And Quality Life In Pre-Lung Transplant Patients?
- ClinicalTrials.gov ID
- NCT01080703
- Acronym / sponsor ID
- Resistance / 10-076-B
- Conditions
- Pulmonary Disease
- Keywords
- Lung Transplant, Quadriceps Strength, Quality of Life, Patients with pulmonary disease awaiting lung transplant.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower extremity strengthening | Experimental | Other: Exercise |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients preparing for lung transplant
- Diagnoses included are: Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Cystic Fibrosis, or Bronchiectasis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseLower extremity resistance exercises and aerobic exercises 3 times a week in 10 week pulmonary rehabilitation program prior to lung transplant. | Other | Lower extremity strengthening |
Primary outcome
Quadriceps Strength
Time frame: 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.
1 secondary outcome
Quality of Life Survey
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward R Garrity, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Pulmonary Disease, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Strength (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014; AzTrials last refreshed its copy on 30 Oct 2026.