The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Hypertension; Interstitial Lung Disease
• Intervention / Treatment: Behavioral: Home Exercise Program, Aerobic Plus Strength Training; Behavioral: Home Exercise Program, Aerobic Only

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Lachant, DO; Phone Number: 585 273 4608; Email: Daniel_Lachant@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic Plus Strength Training; 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.	Behavioral: Home Exercise Program, Aerobic Plus Strength Training; 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.
Active Comparator: Aerobic only; Participants receive 16 weeks of structured daily aerobic exercise messages with heart rate guidance. Participants may perform walking or Cubii-based aerobic exercise.	Behavioral: Home Exercise Program, Aerobic Only; Structured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic activities with heart rate guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	From enrollment to 16 weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Liquidia Technologies, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Exercise Therapy; Home Exercise; PH-ILD
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Lung Diseases, Interstitial; Hypertension, Pulmonary; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: STUDY00011156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No