Home Rehabilitation for Pulmonary Hypertension

Overseen By Daniel Lachant, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Vasodilators

Disqualifiers: Pregnancy, Tachycardia, Inability to walk, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a home exercise program can help people with Pulmonary Arterial Hypertension (PAH) improve heart health and quality of life. Participants will either follow a special exercise routine at home or continue with their usual care. The researchers aim to determine if home exercise can make the heart work more efficiently during activities like walking. Individuals diagnosed with PAH, on stable medication, and with access to a smartphone or email might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance daily living for those with PAH.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been on stable vasodilator dosing for at least 30 days before starting the study, with no planned changes during the 12-week study period.

What prior data suggests that this home rehabilitation program is safe for patients with Pulmonary Arterial Hypertension?

A previous study found the home-based rehabilitation program for patients with Pulmonary Arterial Hypertension (PAH) to be safe and effective. The program improved patients' functional abilities without causing serious side effects. Research has shown that exercise training does not worsen the condition. Overall, this type of exercise is well-tolerated by patients and enhances their exercise capacity and quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the home rehabilitation approach for pulmonary hypertension because it offers a unique way to manage the condition outside of a clinical setting. Unlike traditional treatments that often rely on medications such as vasodilators and anticoagulants, this method focuses on empowering patients to actively participate in their own care through structured exercise programs. Home rehabilitation could potentially improve patients' quality of life by making it easier to adhere to treatment routines and by promoting physical activity tailored to their individual needs. This approach is particularly promising because it shifts part of the management from hospitals to the comfort of patients' homes, which can enhance accessibility and convenience.

What evidence suggests that home rehabilitation is effective for pulmonary hypertension?

Research has shown that rehabilitation exercises at home can benefit people with pulmonary arterial hypertension (PAH). In this trial, participants in the Exercise Intervention Group will engage in a home-based rehabilitation program. Studies have found that exercise training can enhance exercise capacity and quality of life for patients with pulmonary hypertension. For instance, a home-based program proved safe and effective, improving health measures related to daily activities. Another study demonstrated that exercise programs conducted at home were as effective as those in specialized centers. These findings suggest that home rehabilitation could help manage PAH by improving physical fitness and overall well-being. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Follows at University of Rochester Medical Center Pulmonary Hypertension Clinic

Access to a smart phone or email to receive daily messages. If patients do not have access to either, a smartphone with cellular service will be offered for use during the study

Clinically stable by the investigator

Exclusion Criteria

WHO Functional Class IV

Lack of access to email or text messaging

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a home rehabilitation program aimed at decreasing cardiac effort and improving quality of life

12 weeks

Home-based program with periodic virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home Rehabilitation

Trial Overview 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.

How Is the Trial Designed?

Group I: Exercise Intervention Group Experimental Treatment 1 Intervention

Group II: Standard of Care Placebo Group 1 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

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

United Therapeutics

Industry Sponsor

Trials

112

Recruited

14,500+

Dr. Martine Rothblatt

United Therapeutics

Chief Executive Officer since 1996

PhD in Medical Ethics from the Royal London College of Medicine and Dentistry, JD and MBA from UCLA

Dr. Michael Benkowitz

United Therapeutics

Chief Medical Officer since 2023

MD from Harvard Medical School

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

University of Vermont Medical Center

Collaborator

Trials

46

Recruited

25,900+

Published Research Related to This Trial

In a study of 30 patients with pulmonary arterial hypertension (PAH), both hospital-based and home-based cardiopulmonary rehabilitation programs did not show significant improvements in functional status, quality of life, depression severity, or hemodynamic parameters after eight weeks.

The findings suggest that short-term cardiopulmonary rehabilitation may not be effective for patients with PAH, indicating a need for longer rehabilitation programs to potentially achieve better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cardiopulmonary rehabilitation on pulmonary arterial hypertension: A prospective, randomized study. Karapolat, H., Çınar, ME., Tanıgör, G., et al.[2022]

A 6-month home-based rehabilitation program for patients with pulmonary arterial hypertension (PAH) significantly improved walking distance (6MWT) and respiratory muscle strength, with benefits lasting for at least 6 months after the program ended.

The program was safe, with high adherence rates (around 92%) and no serious adverse events reported, indicating that it can be a viable option for enhancing the quality of life in stable PAH patients on optimal medical treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of a simple home-based rehabilitation program in pulmonary arterial hypertension: an interventional pilot study. Wojciuk, M., Ciolkiewicz, M., Kuryliszyn-Moskal, A., et al.[2023]

A study involving 138 patients with pulmonary hypertension showed that a physiotherapy well-being review can effectively identify rehabilitation needs and facilitate access to community-based rehabilitation programs, with 52% of patients referred for such services.

At the end of the study, 32% of patients were able to engage in independent exercise, highlighting the potential benefits of tailored rehabilitation interventions for patients on targeted drug therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring a physiotherapy well-being review to deliver community-based rehabilitation in patients with pulmonary hypertension. Keen, C., Hashmi-Greenwood, M., York, J., et al.[2023]

This trial will compare the effectiveness of self-monitored, home-based rehabilitation versus traditional hospital-based rehabilitation in 240 patients with moderate to severe COPD, aiming to determine if home-based methods can be as effective in improving patients' breathing difficulties over 12 months.

The study will also evaluate whether home-based rehabilitation can lead to reduced healthcare usage and lower costs compared to hospital-based rehabilitation, addressing important gaps in pulmonary rehabilitation accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: rationale and methods. Maltais, F., Bourbeau, J., Lacasse, Y., et al.[2018]

In a study of 418 patients with chronic obstructive pulmonary disease (COPD), pulmonary rehabilitation (PR) significantly improved exercise capacity but did not lead to any changes in resting blood pressure, indicating that PR may not be effective for lowering blood pressure in these patients.

Subgroup analysis of patients with known hypertension or cardiovascular disease also showed no impact of PR on blood pressure, suggesting that the mechanism of action for improving arterial stiffness through PR is unlikely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does pulmonary rehabilitation reduce peripheral blood pressure in patients with chronic obstructive pulmonary disease? Canavan, JL., Kaliaraju, D., Nolan, CM., et al.[2022]

Exercise-based rehabilitation is emerging as a beneficial treatment for patients with pulmonary arterial hypertension (PAH), aimed at improving their functional capacity and quality of life.

A review of ongoing trials revealed 57 registered studies on exercise training for PAH, with seven meeting inclusion criteria, indicating a growing recognition of the importance of rehabilitation alongside traditional medical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of ongoing trials in exercise based rehabilitation for pulmonary arterial hypertension. Babu, AS., Padmakumar, R., Maiya, AG.[2023]

The SPHERe study is a randomized controlled trial involving 352 adults with pulmonary hypertension, aiming to evaluate the effectiveness of a supervised exercise rehabilitation program compared to usual care in an outpatient setting.

The primary outcome will be measured using the incremental shuttle walk test at 4 months, with secondary outcomes including health-related quality of life and time to clinical worsening, providing comprehensive insights into the intervention's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial. McGregor, G., Bruce, J., Ennis, S., et al.[2021]

A home-based pulmonary rehabilitation (HBPR) program for Veterans showed significant improvements in various health outcomes, including reduced dyspnea, increased exercise capacity, and enhanced quality of life, after a 12-week intervention involving 285 participants.

The program was found to be safe, with no reported adverse events, and it offers a valuable alternative for Veterans who may have limited access to traditional pulmonary rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Home-Based Pulmonary Rehabilitation Program in Veterans. Drwal, KR., Hurst, D., Wakefield, BJ.[2022]

Outpatient pulmonary rehabilitation for patients with pulmonary arterial hypertension (PAH) is both safe and effective, leading to significant improvements in exercise capacity, as shown by a 32-meter increase in the 6-minute walking distance (6MWD) after 12 weeks of rehabilitation.

In contrast, the control group experienced a decrease in 6MWD by 26 meters, highlighting the benefits of rehabilitation; additionally, peak oxygen uptake (VO2) improved in the rehabilitation group, while it declined in the control group, indicating enhanced physical performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory rehabilitation improves exercise capacity in patients with pulmonary hypertension. Fox, BD., Kassirer, M., Weiss, I., et al.[2022]

A 12-week Home-Care Rehabilitation Program (HCRP) for 15 COPD patients showed significant improvements in walking distance and maximal workload, indicating its effectiveness in enhancing physical capabilities.

The program was deemed feasible and useful by healthcare providers, with high patient compliance and no major issues reported, suggesting that home-based rehabilitation can be a valuable alternative to traditional hospital-based programs for managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effects of a home-care rehabilitation program in patients with chronic obstructive pulmonary disease. Strijbos, JH., Postma, DS., van Altena, R., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7330286/

Effectiveness and safety of exercise training ... Exercise training is associated with a significant improvement in exercise capacity, cardiorespiratory fitness and quality of life among patients with PH

2. sciencedirect.com sciencedirect.com/science/article/pii/S1443950622009374

Review Exercise Rehabilitation Training in Patients With ... The results suggested that short-term ERT can significantly improve the patients' 6MWD, peak VO2, maximal workload, and O2 pulse. Three (3) months of ERT ...

3. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-021-00315-y

Effectiveness and safety of a simple home-based ... According to study results, the home-based rehabilitation program dedicated to PAH patients is safe and effective. It improves functional parameters and ...

4. publications.ersnet.org publications.ersnet.org/content/errev/34/177/250102

Effectiveness and safety of home-based versus centre-based ... Home-based exercise interventions appear to be viable alternatives to centre-based programmes for patients with pulmonary hypertension, showing comparable ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9724887/

Effectiveness of home-based pulmonary rehabilitation Compared to usual care, home-PR significantly improved exercise capacity (standardised mean difference (SMD) 0.88, 95% CI 0.32–1.44; p=0.002) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8316895/

Effectiveness and safety of a simple home-based ... According to study results, the home-based rehabilitation program dedicated to PAH patients is safe and effective. It improves functional parameters and ...

7. ahajournals.org ahajournals.org/doi/10.1161/circheartfailure.115.002130

Efficacy and Safety of Exercise Training in Chronic ... Exercise training in patients with pulmonary hypertension appears safe and is associated with a significant improvement in exercise capacity, pulmonary ...

8. journal.chestnet.org journal.chestnet.org/article/S0012-3692(21)03366-3/fulltext

HOME-BASED EXERCISE PROGRAMS IN PULMONARY ... Outcomes assessed typically at 12-16 weeks included change in 6-minute walking distance, QoL scores, cardiopulmonary exercise, biochemical and hemodynamic ...