Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease

22 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • New York
      • Rochester, New York, Stati Uniti, 14642
        • Reclutamento
        • University of Rochester Medical Center
        • Investigatore principale:
          • Daniel Lachant, DO
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change in Cardiac Effort From Baseline to 16 Weeks
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change in Six Minute Walk Distance From Baseline to 16 Weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Rochester

Collaboratori

Liquidia Technologies, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 luglio 2026

Completamento primario (Stimato)

30 maggio 2027

Completamento dello studio (Stimato)

30 maggio 2027

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 luglio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00011156

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi