Home Rehabilitation for Pulmonary Hypertension
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Rochester
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate whether a home rehabilitation program for patients diagnosed with Pulmonary Arterial Hypertension (PAH) will decrease Cardiac Effort (number of heart beats used during 6-minute walk test/walk distance) and improve quality of life. Ultimately, this information could help improve the management of patients with PAH.
Is home rehabilitation a promising treatment for pulmonary hypertension?Yes, home rehabilitation is a promising treatment for pulmonary hypertension. Studies show that it can improve exercise capacity and is a good way to make rehabilitation more available to patients. It is also considered effective and safe when supervised properly.12379
What safety data exists for home rehabilitation in pulmonary hypertension?The study titled 'Effectiveness of a Home-Based Pulmonary Rehabilitation Program in Veterans' found that a home-based pulmonary rehabilitation program is safe, as no adverse events were reported. Another study, 'Effectiveness and safety of a simple home-based rehabilitation program in pulmonary arterial hypertension,' also assessed the safety of a home-based rehabilitation program, indicating its potential safety for patients with pulmonary arterial hypertension.478910
What data supports the idea that Home Rehabilitation for Pulmonary Hypertension is an effective treatment?The available research shows that home-based rehabilitation programs can be effective for patients with pulmonary hypertension. One study found that a 6-month home-based program, supervised by caregivers, was both effective and safe for patients with this condition. Another study highlighted that outpatient rehabilitation, which can include home-based exercises, improved exercise capacity in patients. While there is more evidence for hospital-based programs, these findings suggest that home rehabilitation can be a beneficial alternative, especially for those who prefer or need to exercise at home.35679
Do I need to stop my current medications for this trial?The trial does not specify if you need to stop your current medications. However, you must be on stable vasodilator dosing for at least 30 days before the trial and no planned changes to this medication should occur during the 12-week study.
Eligibility Criteria
This trial is for patients with Pulmonary Arterial Hypertension (PAH), a type of high blood pressure affecting the lungs. Participants should be able to perform physical activities as part of a home rehabilitation program aimed at reducing cardiac effort and improving quality of life.Exclusion Criteria
I can follow daily instructions and perform two 6-minute walk tests at home.
I have been diagnosed with a type of pulmonary hypertension that is not caused by left heart disease.
I cannot walk.
I need more than 6 liters per minute of oxygen when resting.
Treatment Details
The study tests if a home-based exercise regimen can help PAH patients by decreasing the heart's workload during activity, measured by beats per minute over distance walked in six minutes, compared to standard care without this program.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Exercise Intervention GroupExperimental Treatment1 Intervention
Group II: Standard of CarePlacebo Group1 Intervention
Home Rehabilitation is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Home Rehabilitation for:
- Pulmonary Arterial Hypertension (PAH)
- Improvement of Cardiac Effort
- Enhancement of Quality of Life
🇺🇸 Approved in United States as Home Rehabilitation for:
- Pulmonary Arterial Hypertension (PAH)
- Improvement of Cardiac Effort
- Enhancement of Quality of Life
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Rochester Medical CenterRochester, NY
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Who is running the clinical trial?
University of RochesterLead Sponsor
United TherapeuticsIndustry Sponsor
Mayo ClinicCollaborator
References
Feasibility and effects of a home-care rehabilitation program in patients with chronic obstructive pulmonary disease. [2019]Pulmonary rehabilitation programs often show beneficial effects in patients with chronic obstructive pulmonary disease (COPD). These programs are usually hospital-based. This study assesses the feasibility and application of a 12-week Home-Care Rehabilitation Program (HCRP), carried out by general practitioners, physiotherapists, and home-care nurses.
A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: rationale and methods. [2018]Pulmonary rehabilitation remains largely underused. Self-monitored, home-based rehabilitation is a promising approach to improving the availability of pulmonary rehabilitation.
Ambulatory rehabilitation improves exercise capacity in patients with pulmonary hypertension. [2022]Rehabilitation is a central treatment modality for patients with chronic cardiopulmonary disease. Physical exertion for patients with pulmonary arterial hypertension (PAH) has typically been discouraged. Inpatient pulmonary rehabilitation has been shown to improve exercise capacity in patients with PAH. The present study aimed to evaluate outpatient pulmonary rehabilitation for patients with PAH.
A review of ongoing trials in exercise based rehabilitation for pulmonary arterial hypertension. [2023]Exercise based rehabilitation for patients with pulmonary arterial hypertension (PAH) is a new treatment option for these patients to improve their functional capacity and quality of life. Despite the benefits seen in cardiopulmonary rehabilitation in various other conditions, it has been underutilized for the patients with PAH. A review of currently registered ongoing trials on exercise training for patients with PAH from the World Health Organization International Clinical Trial Registry Platform was done using the key words "rehabilitation", "exercise training", "pulmonary artery hypertension" and "pulmonary hypertension" for a period of 10 years (2002-2012). The search revealed 57 registered trials in various trial registries from which seven met the inclusion criteria. The current studies are being carried out in Germany (n=4), Brazil (n=1), Australia (n=1) and India (n=1). This indicates a shift in focus from the only medical management to the rehabilitation and long term care for patients with PAH.
Does pulmonary rehabilitation reduce peripheral blood pressure in patients with chronic obstructive pulmonary disease? [2022]Pulmonary rehabilitation (PR) can improve aerobic exercise capacity, health-related quality of life and dyspnoea in patients with chronic obstructive pulmonary disease (COPD). Recent studies have suggested that exercise training may improve blood pressure and arterial stiffness, albeit in small highly selected cohorts. The aim of the study was to establish whether supervised outpatient or unsupervised home PR can reduce peripheral blood pressure. Resting blood pressure was measured in 418 patients with COPD before and after outpatient PR, supervised by a hospital-based team (HOSP). Seventy-four patients with COPD undergoing an unsupervised home-based programme acted as a comparator group (HOME). Despite significant improvements in mean (95% confidence interval) exercise capacity in the HOSP group (56 (50-60) m, p
Effects of cardiopulmonary rehabilitation on pulmonary arterial hypertension: A prospective, randomized study. [2022]This study aims to investigate the effects of cardiopulmonary rehabilitation (CPR) on cardiopulmonary function, quality of life, depression, and hemodynamic parameters in patients with pulmonary arterial hypertension (PAH) and to compare the efficacy of hospital- and home-based exercise programs.
Exploring a physiotherapy well-being review to deliver community-based rehabilitation in patients with pulmonary hypertension. [2023]Highly structured, supervised exercise training has been shown to be beneficial in patients with pulmonary hypertension. Despite evidence of the effectiveness of community-based rehabilitation in other cardiopulmonary diseases, there are limited data in patients with pulmonary hypertension.
Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial. [2021]Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting.
Effectiveness and safety of a simple home-based rehabilitation program in pulmonary arterial hypertension: an interventional pilot study. [2023]Rehabilitation plays an important role in the management of patients with pulmonary arterial hypertension (PAH) and current guidelines recommend implementation of a monitored individualized exercise training program as adjuvant therapy for stable PAH patients on optimal medical treatment. An optimal rehabilitation model for this group of patients has not yet been established. This randomized prospective study assessed the effectiveness and safety of a 6-month home-based caregiver-supervised rehabilitation program among patients with pulmonary arterial hypertension.
Effectiveness of a Home-Based Pulmonary Rehabilitation Program in Veterans. [2022]Purpose: This study examined the effectiveness and safety of a home-based pulmonary rehabilitation (HBPR) program in Veterans. Methods: Patients were evaluated from five Veteran Affairs facilities that enrolled in the 12-week program. Pre- to postchanges were completed on clinical outcomes using paired t-tests and the Wilcoxon signed rank sum test. Descriptive statistics were used for patient demographics, emergency room visits, and hospitalizations. Results: Two hundred eighty-five patients with a mean age of 69.6 ± 8.3 years enrolled in the HBPR program from October 2018 to March 2020. There was a 62% (n = 176) completion rate of both pre- and post assessments. Significant improvements were detected after completion of the HBPR program in dyspnea (modified Medical Research Council: 3.1 ± 1.1 vs. 1.9 ± 1.1; p < 0.0001); exercise capacity (six-minute walk distance: 263.1 m ± 96.6 m vs. 311.0 m ± 103.6 m; p < 0.0001; Duke Activity Status Index: 13.8 ± 9.6 vs. 20.0 ± 12.7; p < 0.0001; self-reported steps per day: 1514.5 ± 1360.4 vs. 3033.8 ± 2716.2; p < 0.0001); depression (patient health questionnaire-9: 8.3 ± 5.7 vs. 6.4 ± 5.1); nutrition habits (rate your plate, heart: 45.3 ± 9.0 vs. 48.9 ± 9.2; p < 0.0001); multicomponent assessment tools (BODE Index: 5.1 ± 2.5 vs. 3.4 ± 2.4; p < 0.0001), GOLD ABCD Assessment: p < 0.0009); and quality of life (chronic obstructive pulmonary disease assessment test: 25.4 ± 7.7 vs. 18.7 ± 8.5; p < 0.0001). No adverse events were reported due to participation in HBPR. Conclusions: The HBPR program is a safe and effective model and provides an additional option to address the gap in pulmonary rehabilitation access and utilization in the Veterans Affairs.