Pulmonary HypertensionNCT07561034
The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease
A study testing Home Exercise Program, Aerobic Plus Strength Training and Home Exercise Program, Aerobic Only in people with Pulmonary Hypertension and Interstitial Lung Disease, run by University of Rochester at 1 site in United States.
Trial summary
This study evaluates the effects of a structured home exercise program in participants with pulmonary hypertension associated with interstitial lung disease. Participants will complete a defined exercise regimen over a 16-week period, and functional capacity and patient reported outcomes will be assessed at baseline… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Interstitial Lung Disease
- What is being tested?
- Home Exercise Program, Aerobic Plus Strength Training and Home Exercise Program, Aerobic Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Follows at University of Rochester Medical Center Pulmonary Hypertension Clinic.
- Adult patients (>18 years old) with right heart catheterization confirmed pulmonary hypertension interstitial lung disease on stable therapy dosing for at least 30 days.
- Access to a smart phone or email to receive daily messages.
- Clinically stable by the investigator.
Who cannot join
- Pregnancy.
- Pulmonary Hypertension Groups 1,2,4,5.
- Resting tachycardia >120 beats/m during screening.
- Inability to walk.
- WHO Functional Class IV
- Lack of access to email or text messaging.
- Participating in a rehabilitation program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Daniel Lachant, DO, 5852734608, daniel_lachant@urmc.rochester.edu
Daniel Lachant, DO
About this study
This study evaluates the effects of a structured home exercise program in participants with pulmonary hypertension associated with interstitial lung disease. Participants will complete a defined exercise regimen over a 16-week period, and functional capacity and patient reported outcomes will be assessed at baseline and after the intervention. The study aims to determine whether a home-based exercise approach is feasible and associated with improvements in functional performance.
Read the detailed description
Pulmonary hypertension associated with interstitial lung disease is associated with reduced exercise capacity, decreased quality of life, and increased morbidity. Exercise based interventions may improve functional status in this population; however, access to supervised rehabilitation programs may be limited. Home based exercise programs offer a potentially accessible alternative, but their feasibility and effectiveness in this population are not well established.
In this interventional study, participants with pulmonary hypertension associated with interstitial lung disease will be enrolled and assigned to a structured home exercise program. The intervention will be performed over a 16-week period. Participants will undergo baseline assessments prior to starting the exercise program and follow up assessments at the end of the intervention period.
Assessments will include measures of functional capacity and patient reported outcomes collected using standardized methods. The primary objective is to evaluate changes in functional performance following completion of the home exercise program. Secondary objectives include evaluation of participant reported outcomes and feasibility of the intervention.
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Being tested
- Home Exercise Program, Aerobic Plus Strength Training, Home Exercise Program, Aerobic Only
- Keywords
- Home Exercise, Exercise Therapy, PH-ILD
- 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.
Home Exercise Program, Aerobic Plus Strength TrainingBehavioural
Structured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic and strength training activities with heart rate guidance.
Home Exercise Program, Aerobic OnlyBehavioural
Structured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic activities with heart rate guidance.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Plus Strength Training | Experimental | Participants receive 16 weeks of structured daily exercise messages for aerobic and strength training activities with heart rate guidance. Participants also receive resistance bands and ankle weights. Receives: Behavioral: Home Exercise Program, Aerobic Plus Strength Training |
| Aerobic only | Active comparator | Participants receive 16 weeks of structured daily aerobic exercise messages with heart rate guidance. Participants may perform walking or Cubii-based aerobic exercise. Receives: Behavioral: Home Exercise Program, Aerobic Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Cardiac Effort From Baseline to 16 Weeks
Cardiac Effort is measured as the ratio of the total number of heart beats recorded during the Six Minute Walk Test to the total distance walked in meters. Heart rate is continuously monitored during the test using a validated heart rate monitoring device. The value represents the number of heart beats required per unit distance walked (beats per meter). Individual participant values are calculated at baseline and at 16 weeks. The outcome is defined as the mean change in Cardiac Effort from baseline to 16 weeks across participants. Lower values indicate improved cardiac efficiency and better functional performance, while higher values indicate reduced efficiency and worse functional status.
Measured: Baseline to 16 weeks
Secondary outcomes (6)
Mean Change in Six Minute Walk Distance From Baseline to 16 Weeks
Six Minute Walk Distance is measured using the standardized Six Minute Walk Test according to established clinical guidelines. The total distance walked in meters during six minutes is recorded for each participant. Individual participant values are collected at baseline and at 16 weeks. The outcome is defined as the mean change in distance walked from baseline to 16 weeks across participants. Higher values indicate improved functional capacity, while lower values indicate reduced exercise tolerance.
Measured: Baseline to 16 weeks
Mean Change in emPHasis-10 Score From Baseline to 16 Weeks
Quality of life is measured using the emPHasis-10 questionnaire, a validated patient reported outcome instrument specific to pulmonary hypertension. The questionnaire consists of 10 items assessing symptoms and impact on daily life. Scores range from 0 to 50, with higher scores indicating worse health related quality of life. Individual participant scores are calculated by summing item responses. The outcome is defined as the mean change in total score from baseline to 16 weeks across participants.
Measured: Baseline to 16 weeks post intervention
Mean Change in King's Brief Interstitial Lung Disease Questionnaire Score From Baseline to 16 Weeks
Quality of life is measured using the King's Brief Interstitial Lung Disease questionnaire, a validated instrument assessing health status in interstitial lung disease. Scores range from 0 to 100, with higher scores indicating better health status. Individual participant scores are calculated according to standard scoring procedures. The outcome is defined as the mean change in score from baseline to 16 weeks across participants.
Measured: Baseline to 16 weeks
Mean Change in Lower Extremity Muscle Strength From Baseline to 16 Weeks
Muscle strength is measured using a Lafayette Muscle Dynamometer for quadriceps strength and a Jamar Hand Dynamometer for hand grip strength. Measurements are recorded in pounds (lbs) for each participant. Individual participant values are obtained at baseline and at 16 weeks. The outcome is defined as the mean change in muscle strength from baseline to 16 weeks across participants. Higher values indicate greater muscle strength, while lower values indicate reduced strength.
Measured: Baseline to 16 weeks
Number of Participants With Healthcare Utilization Events During the 16 Week Study Period
Healthcare utilization events include unplanned medical visits such as emergency department visits, hospitalizations, and clinic visits occurring during the study period. Events are collected through participant self report and study follow up. The outcome is defined as the number of participants experiencing at least one healthcare utilization event during the study period.
Measured: From enrollment to 16 weeks
Number of Participants With Falls During the 16 Week Study Period
Falls are defined as any unintentional event resulting in a participant coming to rest on the ground or a lower level. Falls are self reported by participants during weekly check-ins throughout the study period. The outcome is defined as the number of participants experiencing at least one fall during the study period.
Measured: From enrollment to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start15 Jul 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Liquidia Technologies, Inc.
- Responsible party
- Principal investigator, Daniel Lachant, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561034
- Sponsor's protocol ID
- STUDY00011156
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07561034
- Acronym / sponsor ID
- STUDY00011156
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Keywords
- Home Exercise, Exercise Therapy, PH-ILD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Liquidia Technologies, Inc.
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- 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 evaluates the effects of a structured home exercise program in participants with pulmonary hypertension associated with interstitial lung disease. Participants will complete a defined exercise regimen over a 16-week period, and functional capacity and patient reported outcomes will be assessed at baseline and after the intervention. The study aims to determine whether a home-based exercise approach is feasible and associated with improvements in functional performance.
Detailed description
Pulmonary hypertension associated with interstitial lung disease is associated with reduced exercise capacity, decreased quality of life, and increased morbidity. Exercise based interventions may improve functional status in this population; however, access to supervised rehabilitation programs may be limited. Home based exercise programs offer a potentially accessible alternative, but their feasibility and effectiveness in this population are not well established.
In this interventional study, participants with pulmonary hypertension associated with interstitial lung disease will be enrolled and assigned to a structured home exercise program. The intervention will be performed over a 16-week period. Participants will undergo baseline assessments prior to starting the exercise program and follow up assessments at the end of the intervention period.
Assessments will include measures of functional capacity and patient reported outcomes collected using standardized methods. The primary objective is to evaluate changes in functional performance following completion of the home exercise program. Secondary objectives include evaluation of participant reported outcomes and feasibility of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Plus Strength Training | Experimental | Behavioral: Home Exercise Program, Aerobic Plus Strength TrainingParticipants receive 16 weeks of structured daily exercise messages for aerobic and strength training activities with heart rate guidance. Participants also receive resistance bands and ankle weights. |
| Aerobic only | Active comparator | Behavioral: Home Exercise Program, Aerobic OnlyParticipants receive 16 weeks of structured daily aerobic exercise messages with heart rate guidance. Participants may perform walking or Cubii-based aerobic exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Follows at University of Rochester Medical Center Pulmonary Hypertension Clinic.
- Adult patients (>18 years old) with right heart catheterization confirmed pulmonary hypertension interstitial lung disease on stable therapy dosing for at least 30 days.
- Access to a smart phone or email to receive daily messages.
- Clinically stable by the investigator.
Key exclusion criteria (7 listed)
- Pregnancy.
- Pulmonary Hypertension Groups 1,2,4,5.
- Resting tachycardia >120 beats/m during screening.
- Inability to walk.
- WHO Functional Class IV
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 |
|---|---|---|
| Home Exercise Program, Aerobic Plus Strength TrainingStructured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic and strength training activities with heart rate guidance. | Behavioural | Aerobic Plus Strength Training |
| Home Exercise Program, Aerobic OnlyStructured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic activities with heart rate guidance. | Behavioural | Aerobic only |
Primary outcome
Mean Change in Cardiac Effort From Baseline to 16 Weeks
Time frame: Baseline to 16 weeks
Cardiac Effort is measured as the ratio of the total number of heart beats recorded during the Six Minute Walk Test to the total distance walked in meters. Heart rate is continuously monitored during the test using a validated heart rate monitoring device. The value represents the number of heart beats required per unit distance walked (beats per meter). Individual participant values are calculated at baseline and at 16 weeks. The outcome is defined as the mean change in Cardiac Effort from baseline to 16 weeks across participants. Lower values indicate improved cardiac efficiency and better functional performance, while higher values indicate reduced efficiency and worse functional status.
6 secondary outcomes
Mean Change in Six Minute Walk Distance From Baseline to 16 Weeks
Time frame: Baseline to 16 weeks
Mean Change in emPHasis-10 Score From Baseline to 16 Weeks
Time frame: Baseline to 16 weeks post intervention
Mean Change in King's Brief Interstitial Lung Disease Questionnaire Score From Baseline to 16 Weeks
Time frame: Baseline to 16 weeks
Mean Change in Lower Extremity Muscle Strength From Baseline to 16 Weeks
Time frame: Baseline to 16 weeks
Number of Participants With Healthcare Utilization Events During the 16 Week Study Period
Time frame: From enrollment to 16 weeks
Number of Participants With Falls During the 16 Week Study Period
Time frame: From enrollment to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Program, Aerobic Plus Strength Training and Home Exercise Program, Aerobic Only in people with Pulmonary Hypertension and Interstitial Lung Disease, run by University of Rochester 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Jul 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lachant, DO (585 273 4608, Daniel_Lachant@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Cardiac Effort From Baseline to 16 Weeks (time frame: Baseline to 16 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 24 Jul 2026.