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The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease

22 de julio de 2026 actualizado por: Daniel Lachant, University of Rochester
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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • New York
      • Rochester, New York, Estados Unidos, 14642
        • Reclutamiento
        • University of Rochester Medical Center
        • Investigador principal:
          • Daniel Lachant, DO
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Conductual: 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.
Comparador activo: 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.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change in Cardiac Effort From Baseline to 16 Weeks
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change in Six Minute Walk Distance From Baseline to 16 Weeks
Periodo de tiempo: 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
Periodo de tiempo: Baseline to 16 weeks post intervention
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From enrollment to 16 weeks
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
Periodo de tiempo: From enrollment to 16 weeks
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Rochester

Colaboradores

Liquidia Technologies, Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de julio de 2026

Finalización primaria (Estimado)

30 de mayo de 2027

Finalización del estudio (Estimado)

30 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de abril de 2026

Publicado por primera vez (Actual)

1 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de julio de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00011156

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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