The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home Exercise Program, Aerobic Plus Strength Training, Home Exercise Program, Aerobic Only.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension, Interstitial Lung Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Mean Change in Cardiac Effort From Baseline to 16 Weeks [Time frame: Baseline to 16 weeks]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT07561034 · STUDY00011156