The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease
2026년 7월 22일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Daniel Lachant, DO
- 전화번호: 585 273 4608
- 이메일: Daniel_Lachant@urmc.rochester.edu
연구 장소
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New York
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Rochester, New York, 미국, 14642
- 모병
- University of Rochester Medical Center
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수석 연구원:
- Daniel Lachant, DO
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연락하다:
- Daniel Lachant, DO
- 전화번호: 5852734608
- 이메일: daniel_lachant@urmc.rochester.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
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- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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활성 비교기: 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.
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Structured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic activities with heart rate guidance.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Change in Cardiac Effort From Baseline to 16 Weeks
기간: Baseline to 16 weeks
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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.
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Baseline to 16 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Change in Six Minute Walk Distance From Baseline to 16 Weeks
기간: Baseline to 16 weeks
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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.
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Baseline to 16 weeks
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Mean Change in emPHasis-10 Score From Baseline to 16 Weeks
기간: Baseline to 16 weeks post intervention
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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.
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Baseline to 16 weeks post intervention
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Mean Change in King's Brief Interstitial Lung Disease Questionnaire Score From Baseline to 16 Weeks
기간: Baseline to 16 weeks
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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.
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Baseline to 16 weeks
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Mean Change in Lower Extremity Muscle Strength From Baseline to 16 Weeks
기간: Baseline to 16 weeks
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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.
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Baseline to 16 weeks
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Number of Participants With Healthcare Utilization Events During the 16 Week Study Period
기간: From enrollment to 16 weeks
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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.
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From enrollment to 16 weeks
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Number of Participants With Falls During the 16 Week Study Period
기간: From enrollment to 16 weeks
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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.
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From enrollment to 16 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 15일
기본 완료 (추정된)
2027년 5월 30일
연구 완료 (추정된)
2027년 5월 30일
연구 등록 날짜
최초 제출
2026년 4월 24일
QC 기준을 충족하는 최초 제출
2026년 4월 24일
처음 게시됨 (실제)
2026년 5월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 22일
마지막으로 확인됨
2026년 4월 1일
추가 정보
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