The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease

NCT07561034 | Not Yet Recruiting

• 1 other identifier: STUDY00011156
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 and after the intervention. The study aims to determine whether a home-based exercise approach is feasible and associated with improvements in functional performance.

Conditions

Interstitial Lung Disease; Pulmonary Hypertension

Keywords

Home Exercise; Exercise Therapy; PH-ILD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean Change in Six Minute Walk Distance From Baseline to 16 Weeks

  Baseline to 16 weeks

• Mean Change in emPHasis-10 Score From Baseline to 16 Weeks

  Baseline to 16 weeks post intervention

• Mean Change in King's Brief Interstitial Lung Disease Questionnaire Score From Baseline to 16 Weeks

  Baseline to 16 weeks

• Mean Change in Lower Extremity Muscle Strength From Baseline to 16 Weeks

  Baseline to 16 weeks

• Number of Participants With Healthcare Utilization Events During the 16 Week Study Period

  From enrollment to 16 weeks

Study Arms (2)

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.

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.

Behavioral: Home Exercise Program, Aerobic Only

Interventions

Home Exercise Program, Aerobic Plus Strength Training BEHAVIORAL

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.

Aerobic Plus Strength Training

Home Exercise Program, Aerobic Only BEHAVIORAL

Structured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic activities with heart rate guidance.

Aerobic only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liquidia Technologies, Inc.: collaborator
• University of Rochester: lead

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Daniel Lachant, DO

CONTACT

585 273 4608; Daniel_Lachant@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Medicine, Pulmonary Diseases and Critical Care (SMD)

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04