The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean Change in Cardiac Effort From Baseline to 16 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnancy.
- •Pulmonary Hypertension Groups 1,2,4,
- •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.
结局指标
主要结局
Mean Change in Cardiac Effort From Baseline to 16 Weeks
时间窗: 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.
次要结局
- 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)
- Number of Participants With Falls During the 16 Week Study Period(From enrollment to 16 weeks)
研究者
Daniel Lachant
Associate Professor - Department of Medicine, Pulmonary Diseases and Critical Care (SMD)
University of Rochester