Pulmonary HypertensionPhase 2NCT00678821
Aerobic Exercise in Patients With Pulmonary Hypertension
A Phase 2 study testing Aerobic exercise in people with Pulmonary Hypertension and Interstitial Lung Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will determine if a rehabilitation exercise program can help people with pulmonary hypertension (PH) increase their physical activity. Patients with PH have an increase in blood pressure in the pulmonary blood vessels (artery, vein or capillaries) that leads to shortness of breath, dizziness, fainting and… Read more about this study
- Who is it for?
- Ages 21 to 82 years
- Conditions the study is for
- Pulmonary Hypertension, Interstitial Lung Disease
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2008to 23 Sep 2015
- Phase
- Phase 2
- 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 21 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PH and ILD-only Groups: Subjects of this study will include individuals with ILD and PH who are referred for Pulmonary Rehabilitation. Patients with ILD, PH or PH comorbid with ILD will be included. The following list provides more specific inclusion criteria:
- Between age 21-82 years
- WHO functional class II or III, will accept WHO functional class I and IV based on 6 minute walk test results (less than or equal to 400 meters for Class I and greater than or equal to 50 meters for Class IV)
- No recent syncope or significant chest pain
- No prior Pulmonary Rehabilitation received within the last 6 months.
- Physically inactive, no participation in a structured exercise program 3 or more days a week for over 30 minutes at each session including pulmonary rehabilitation maintenance within the last 6 months.
Show all 37Show fewer
- Patients may qualify if they have any one of the following conditions:
- PAH diagnosed by right heart catheterization defined as resting pulmonary mean arterial pressure equal to or higher than 25 mmHg
- Interstitial lung disease, including idiopathic pulmonary fibrosis (IPF), non-specific pulmonary fibrosis (NSPF), sarcoidosis or other form of chronic lung fibrosis will be based on clinical context via clinic note from primary pulmonologist and an echo within one year of enrollment showing an RVSP <40mmHg.
- If RVSP is lower than 40mmHg patients with interstitial lung disease will be enrolled without the need for a right heart catheterization.
- If RVSP is indeterminate on an echo procedure performed within a year of enrollment, the patient will undergo another echo test at The National Institutes of Health, Echocardiogram Laboratory.
- Only if RVSP is unable to be estimated on an echo at NIH, the absence of the following abnormalities on echo will be used: right ventricular enlargement, right ventricular hypertrophy, paradoxical movement of interventricular septum and/or altered pulmonary flow velocity. If RVSP is unable to be estimated and these abnormalities are absent on echo, the patient will be enrolled as an ILD-only patient. If any of these echocardiographic abnormalities are present the patient will not be enrolled until the results of a right heart catheterization can be obtained to verify the absence of pulmonary hypertension.
- Healthy Controls: The controls will include individuals who have never been diagnosed with primary or secondary PH and are apparently healthy. Controls will be matched to the PH cohort for age, gender, and body mass.
- Between 21 82 years
- Physically inactive, no participation in a structured exercise program 3 or more days a week for over 30 minutes at each session.
- No cardiorespiratory or pulmonary disease
- No other diseases of the neurological, metabolic, renal, or musculoskeletal system
- No medications that would influence aerobic capacity or treadmill performance
- EXCLUSION CRITERIA FOR PATIENTS WITH PH, ILD-ONLY AND HEALTHY CONTROLS:
- Since the goal is to examine exercise responses and adaptations as affected by PH, patients will have no other (except the primary disease in those with secondary PH) medical conditions that would impair aerobic capacity or the ability to engage in physical activity. These conditions would include any of those affecting the cardiovascular, pulmonary, metabolic, neurological, or musculoskeletal systems. Specific exclusion criteria for the PH and control cohorts are:
- Significant Restrictive or Obstructive Lung Disease with a FEV1/FVC ratio less than or equal to 65 percent
- Diagnosis of ischemic heart disease
- Left ventricular dysfunction with the ejection fraction less than 40 or a documented pulmonary capillary wedge pressure greater than or equal to 18 mmHg.
- Acute cor pulmonale
- Dilated or hypertrophic cardiomyopathy
- Non-idiopathic cardiomyopathy
- Significant hepatic or renal dysfunction
- Metastatic cancer with a life expectance of less than 6 months
- Disabling stroke
- Active substance abuse
- Severe psychiatric disease
- Patients on Antiretroviral Therapy
- Uncontrolled diabetes mellitus with a history of DKA
- Mitochondrial disease
- Pregnancy
- Ongoing tobacco use
- Children: Individuals younger than 21 years will not be included in the protocol because reference ranges for normative aerobic capacity and aerobic fitness have not been established for these age ranges.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Response and Adaptation to Aerobic Exercise in Patients With Pulmonary Hypertension: Initial Studies for Establishing Guidelines
This study will determine if a rehabilitation exercise program can help people with pulmonary hypertension (PH) increase their physical activity. Patients with PH have an increase in blood pressure in the pulmonary blood vessels (artery, vein or capillaries) that leads to shortness of breath, dizziness, fainting and other symptoms.
Healthy volunteers and people with pulmonary hypertension between 21 and 75 years of age may be eligible for this study.
Read more
All participants undergo the following tests and procedures:
- Medical history and physical examination
- 6-minute walk test: Subjects walk as fast as they can for 6 minutes on a walking track to determine their ability to participate in physical activity.
- Questionnaires: Subjects complete nine questionnaires related to their fatigue, daily physical activity, mood, and so forth.
- Maximum treadmill test: The exercise begins at an easy level and gradually increases until the subject says he or she can no longer continue or the investigator decides it is not safe to continue. Subjects are fitted with a mask, electrodes and light sensors to measure how well the heart is working and how well the muscles use oxygen.
Patients with pulmonary hypertension undergo the following additional procedures:
- Activity monitoring: Patients wear a monitor for 3 days that measures movement and heart rate.
- Group assignment: Patients are randomly assigned to Group 1 (education plus aerobic exercise) or Group 2 (education followed by exercise).
- Group 1 patients will attend classes three days a week at either Inova Fairfax Hospital Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. Two sessions a week will include a 1 hour education session as well as a 30-45 minute track or treadmill exercise session. The third session will only include exercise. During the education patients will learn about a healthy lifestyle with pulmonary hypertension. After the 10 weeks of education and exercise, subjects repeat the 6-minute walk test, maximum treadmill test and questionnaires.
- Group 2 patients participate in 2; 1-hour educational session at either the Inova Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. After the classes, they repeat the 6-minute walk test, maximum treadmill test and questionnaires. The following 10 weeks will consist of 3 days a week of 30-45 minute track or treadmill walking at either Inova or NIH, after which they again repeat the questionnaires, treadmill and walk tests.
Read the detailed description
We propose a randomized trial to determine the safety and effectiveness of aerobic exercise for patients who have primary pulmonary hypertension (PH) or PH secondary to interstitial lung disease (ILD). This project will be the first in a series of studies aimed at establishing exercise prescription and general rehabilitation guidelines for patients who have advanced lung diseases.
An essential treatment for almost all cardiovascular and pulmonary disorders is aerobic exercise training. The effectiveness of exercise rehabilitation has been established and exercise rehabilitation has become a standard of care for patients with chronic obstructive pulmonary disease (COPD). However, fundamental information about the mechanisms underlying exercise training and its therapeutic benefits remains lacking for patients who have advanced lung disease in general and specifically for those with PH.
Subjects will be over the age of 21 years. The patients will be enrolled from sites within a reasonable travel distance from the greater Washington area and will receive their exercise training at Inova Fairfax Hospital or at the National Institutes of Health (NIH) main campus. Exercise-based rehabilitation is already common for patients who have PH at the Inova Fairfax Hospital. Their pulmonary rehabilitation program is well established, and their staff is experienced in providing exercise therapy for patients with PH and advanced lung diseases. The Rehabilitation Medicine Department (RMD) at The NIH Clinical Center has established a pulmonary rehabilitation program for this protocol as well as to provide rehabilitation services for NIH clinic patients.
There will be two primary treatment arms. Patients with PH will be randomized to either aerobic exercise training plus education (AET) or education only (Ed-only) treatments. A comparison group of patients with ILD who do not have secondary PH (ILD-only) will also undergo the AET arm. Exercise training will consist of a 10-week regimen of supervised treadmill or over ground walking three times a week. Exercise session duration will be 30 minutes and will progress to 45 minutes per session over the 10 weeks. The intensity of the exercise will be between 70 and 80% of the heart rate reserve.
There will also be two secondary studies. First, the subjects with PH initially randomized to the education only arm will complete an aerobic exercise training program after participation in education. In addition, we will also compare baseline tests among patients with PH, patients with ILD-only and healthy controls.
The study outcome measures will be assessed at NIH, RMD. These will include pre- and post-exercise training comparisons of symptom limited treadmill exercise tests to assess heart rate, pulse oximetry, EKG, maximum oxygen consumption, bioelectrical impedance cardiography, and near infrared spectroscopy measurements of muscle oxygenation. We will also assess accelerometry based activity, 6-minute walk distance, and a number of other quality of life and functional measures questionnaires including: International Physical Activity Questionnaire, Fatigue Severity Scale, SF-36v2 Health Survey, Human Activity Profile, Stages of Exercise Change, Exercise Self-Efficacy, Profile of Mood States, Cambridge Pulmonary Hypertension Outcome Review.
This study represents a unique opportunity to assess the effects of exercise on patients with advanced lung disease and may open up valuable new treatment options for these patients.
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Being tested
- Aerobic exercise
- Keywords
- Interstitial Lung Disease, Pulmonary Rehabilitation
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Supervised aerobic exercise and educational lectures for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with PH will be randomized to either aerobic exercise training plus education (AET) or education only (Ed-only) treatments Receives: Other: Aerobic exercise |
| 2 | Active comparator | A comparison group of patients with ILD who do not have secondary PH (ILD-only) will also undergo the AET arm Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre and post exercise training CPET
CPET variables
Measured: 10 wks
Accelerometry-based activity
Physical activity participation
Measured: 10 wks
6 minute walk distance
total meters walked in 6 minutes
Measured: 10 wks
Quality of life and functional measures
self-report questionnaires
Measured: 10 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study start12 Jun 2008
- Primary completion23 Sep 2015
- Study completion23 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- George Mason University, Inova Fairfax Hospital
- Responsible party
- Sponsor
- Investigators
- Leighton Chan, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678821
- Sponsor's protocol ID
- 080133
- Other IDs
- 08-CC-0133
- Status last verified
- 4 Nov 2026
- First submitted
- 14 May 2008
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Keyser RE, Christensen EJ, Chin LM, Woolstenhulme JG, Drinkard B, Quinn A, Connors G, Weir NA, Nathan SD, Chan LE. Changes in fatigability following intense aerobic exercise training in patients with interstitial lung disease. Respir Med. 2015 Apr;109(4):517-25. doi: 10.1016/j.rmed.2015.01.021. Epub 2015 Feb 7.
PubMed 25698651Chan L, Chin LMK, Kennedy M, Woolstenhulme JG, Nathan SD, Weinstein AA, Connors G, Weir NA, Drinkard B, Lamberti J, Keyser RE. Benefits of intensive treadmill exercise training on cardiorespiratory function and quality of life in patients with pulmonary hypertension. Chest. 2013 Feb 1;143(2):333-343. doi: 10.1378/chest.12-0993.
PubMed 22922554Weinstein AA, Chin LM, Keyser RE, Kennedy M, Nathan SD, Woolstenhulme JG, Connors G, Chan L. Effect of aerobic exercise training on fatigue and physical activity in patients with pulmonary arterial hypertension. Respir Med. 2013 May;107(5):778-84. doi: 10.1016/j.rmed.2013.02.006. Epub 2013 Mar 7.
PubMed 23478192Woolstenhulme JG, Guccione AA, Herrick JE, Collins JP, Nathan SD, Chan L, Keyser RE. Left Ventricular Function Before and After Aerobic Exercise Training in Women With Pulmonary Arterial Hypertension. J Cardiopulm Rehabil Prev. 2019 Mar;39(2):118-126. doi: 10.1097/HCR.0000000000000397.
PubMed 30624371
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response and Adaptation to Aerobic Exercise in Patients With Pulmonary Hypertension: Initial Studies for Establishing Guidelines
- ClinicalTrials.gov ID
- NCT00678821
- Acronym / sponsor ID
- 080133
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Keywords
- Interstitial Lung Disease, Pulmonary Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- George Mason University, Inova Fairfax Hospital
- Study start
- 12 Jun 2008 (actual)
- Primary completion
- 23 Sep 2015 (actual)
- Study completion
- 23 Sep 2015 (actual)
- First posted
- 16 May 2008 (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.
This study will determine if a rehabilitation exercise program can help people with pulmonary hypertension (PH) increase their physical activity. Patients with PH have an increase in blood pressure in the pulmonary blood vessels (artery, vein or capillaries) that leads to shortness of breath, dizziness, fainting and other symptoms.
Healthy volunteers and people with pulmonary hypertension between 21 and 75 years of age may be eligible for this study.
All participants undergo the following tests and procedures:
- Medical history and physical examination
- 6-minute walk test: Subjects walk as fast as they can for 6 minutes on a walking track to determine their ability to participate in physical activity.
- Questionnaires: Subjects complete nine questionnaires related to their fatigue, daily physical activity, mood, and so forth.
- Maximum treadmill test: The exercise begins at an easy level and gradually increases until the subject says he or she can no longer continue or the investigator decides it is not safe to continue. Subjects are fitted with a mask, electrodes and light sensors to measure how well the heart is working and how well the muscles use oxygen.
Patients with pulmonary hypertension undergo the following additional procedures:
- Activity monitoring: Patients wear a monitor for 3 days that measures movement and heart rate.
- Group assignment: Patients are randomly assigned to Group 1 (education plus aerobic exercise) or Group 2 (education followed by exercise).
- Group 1 patients will attend classes three days a week at either Inova Fairfax Hospital Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. Two sessions a week will include a 1 hour education session as well as a 30-45 minute track or treadmill exercise session. The third session will only include exercise. During the education patients will learn about a healthy lifestyle with pulmonary hypertension. After the 10 weeks of education and exercise, subjects repeat the 6-minute walk test, maximum treadmill test and questionnaires.
- Group 2 patients participate in 2; 1-hour educational session at either the Inova Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. After the classes, they repeat the 6-minute walk test, maximum treadmill test and questionnaires. The following 10 weeks will consist of 3 days a week of 30-45 minute track or treadmill walking at either Inova or NIH, after which they again repeat the questionnaires, treadmill and walk tests.
Detailed description
We propose a randomized trial to determine the safety and effectiveness of aerobic exercise for patients who have primary pulmonary hypertension (PH) or PH secondary to interstitial lung disease (ILD). This project will be the first in a series of studies aimed at establishing exercise prescription and general rehabilitation guidelines for patients who have advanced lung diseases.
An essential treatment for almost all cardiovascular and pulmonary disorders is aerobic exercise training. The effectiveness of exercise rehabilitation has been established and exercise rehabilitation has become a standard of care for patients with chronic obstructive pulmonary disease (COPD). However, fundamental information about the mechanisms underlying exercise training and its therapeutic benefits remains lacking for patients who have advanced lung disease in general and specifically for those with PH.
Subjects will be over the age of 21 years. The patients will be enrolled from sites within a reasonable travel distance from the greater Washington area and will receive their exercise training at Inova Fairfax Hospital or at the National Institutes of Health (NIH) main campus. Exercise-based rehabilitation is already common for patients who have PH at the Inova Fairfax Hospital. Their pulmonary rehabilitation program is well established, and their staff is experienced in providing exercise therapy for patients with PH and advanced lung diseases. The Rehabilitation Medicine Department (RMD) at The NIH Clinical Center has established a pulmonary rehabilitation program for this protocol as well as to provide rehabilitation services for NIH clinic patients.
There will be two primary treatment arms. Patients with PH will be randomized to either aerobic exercise training plus education (AET) or education only (Ed-only) treatments. A comparison group of patients with ILD who do not have secondary PH (ILD-only) will also undergo the AET arm. Exercise training will consist of a 10-week regimen of supervised treadmill or over ground walking three times a week. Exercise session duration will be 30 minutes and will progress to 45 minutes per session over the 10 weeks. The intensity of the exercise will be between 70 and 80% of the heart rate reserve.
There will also be two secondary studies. First, the subjects with PH initially randomized to the education only arm will complete an aerobic exercise training program after participation in education. In addition, we will also compare baseline tests among patients with PH, patients with ILD-only and healthy controls.
The study outcome measures will be assessed at NIH, RMD. These will include pre- and post-exercise training comparisons of symptom limited treadmill exercise tests to assess heart rate, pulse oximetry, EKG, maximum oxygen consumption, bioelectrical impedance cardiography, and near infrared spectroscopy measurements of muscle oxygenation. We will also assess accelerometry based activity, 6-minute walk distance, and a number of other quality of life and functional measures questionnaires including: International Physical Activity Questionnaire, Fatigue Severity Scale, SF-36v2 Health Survey, Human Activity Profile, Stages of Exercise Change, Exercise Self-Efficacy, Profile of Mood States, Cambridge Pulmonary Hypertension Outcome Review.
This study represents a unique opportunity to assess the effects of exercise on patients with advanced lung disease and may open up valuable new treatment options for these patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Aerobic exercisePatients with PH will be randomized to either aerobic exercise training plus education (AET) or education only (Ed-only) treatments |
| 2 | Active comparator | Other: Aerobic exerciseA comparison group of patients with ILD who do not have secondary PH (ILD-only) will also undergo the AET arm |
Who may qualify
- Ages
- 21 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- PH and ILD-only Groups: Subjects of this study will include individuals with ILD and PH who are referred for Pulmonary Rehabilitation. Patients with ILD, PH or PH comorbid with ILD will be included. The following list provides more specific inclusion criteria:
- Between age 21-82 years
- WHO functional class II or III, will accept WHO functional class I and IV based on 6 minute walk test results (less than or equal to 400 meters for Class I and greater than or equal to 50 meters for Class IV)
- No recent syncope or significant chest pain
- No prior Pulmonary Rehabilitation received within the last 6 months.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Aerobic exerciseSupervised aerobic exercise and educational lectures for 10 weeks | Other | 1, 2 |
Primary outcome
Pre and post exercise training CPET
Time frame: 10 wks
CPET variables
Accelerometry-based activity
Time frame: 10 wks
Physical activity participation
6 minute walk distance
Time frame: 10 wks
total meters walked in 6 minutes
Quality of life and functional measures
Time frame: 10 wks
self-report questionnaires
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 6 Nov 2026.
- Background: PubMed 25698651Keyser RE, Christensen EJ, Chin LM, Woolstenhulme JG, Drinkard B, Quinn A, Connors G, Weir NA, Nathan SD, Chan LE. Changes in fatigability following intense aerobic exercise training in patients with interstitial lung disease. Respir Med. 2015 Apr;109(4):517-25. doi: 10.1016/j.rmed.2015.01.021. Epub 2015 Feb 7.
- Background: PubMed 22922554Chan L, Chin LMK, Kennedy M, Woolstenhulme JG, Nathan SD, Weinstein AA, Connors G, Weir NA, Drinkard B, Lamberti J, Keyser RE. Benefits of intensive treadmill exercise training on cardiorespiratory function and quality of life in patients with pulmonary hypertension. Chest. 2013 Feb 1;143(2):333-343. doi: 10.1378/chest.12-0993.
- Background: PubMed 23478192Weinstein AA, Chin LM, Keyser RE, Kennedy M, Nathan SD, Woolstenhulme JG, Connors G, Chan L. Effect of aerobic exercise training on fatigue and physical activity in patients with pulmonary arterial hypertension. Respir Med. 2013 May;107(5):778-84. doi: 10.1016/j.rmed.2013.02.006. Epub 2013 Mar 7.
- Derived from this study: PubMed 30624371Woolstenhulme JG, Guccione AA, Herrick JE, Collins JP, Nathan SD, Chan L, Keyser RE. Left Ventricular Function Before and After Aerobic Exercise Training in Women With Pulmonary Arterial Hypertension. J Cardiopulm Rehabil Prev. 2019 Mar;39(2):118-126. doi: 10.1097/HCR.0000000000000397.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Leighton Chan, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerobic exercise in people with Pulmonary Hypertension and Interstitial Lung Disease, run by National Institutes of Health Clinical Center (CC) 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 37 inclusion and 0 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 6 Nov 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pre and post exercise training CPET (time frame: 10 wks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00678821, which also lists 4 linked publications.
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 6 Nov 2026.