50 Participants Needed

Home Rehabilitation for Pulmonary Hypertension

DL
Overseen ByDaniel Lachant, DO
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
Must be taking: Vasodilators
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Home Rehabilitation for Pulmonary Hypertension?

Research shows that home-based rehabilitation programs can be effective and safe for patients with pulmonary arterial hypertension, improving their exercise capacity and quality of life. Similar programs have also been beneficial for other heart and lung conditions, suggesting that home rehabilitation can be a valuable part of managing pulmonary hypertension.12345

Is home rehabilitation safe for people with pulmonary hypertension?

Research shows that home-based rehabilitation programs are generally safe for people with pulmonary hypertension and other conditions, with no adverse events reported in studies.34678

How is home rehabilitation different from other treatments for pulmonary hypertension?

Home rehabilitation for pulmonary hypertension is unique because it allows patients to perform supervised exercise programs at home, making it more accessible and convenient compared to traditional hospital-based programs. This approach can improve exercise capacity and is designed to be safe and effective for patients with stable pulmonary arterial hypertension.134910

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.

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.

Inclusion Criteria

Clinically stable by the investigator
Follows at University of Rochester Medical Center Pulmonary Hypertension Clinic
I am an adult with confirmed pulmonary hypertension and have been on a stable treatment for over 30 days.
See 2 more

Exclusion Criteria

Pregnancy
Principal Investigator discretion
Resting tachycardia >120 beats/min during screening
See 7 more

Timeline

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

Treatment Details

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.
Participant Groups
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

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+

Findings from Research

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

References

Ambulatory rehabilitation improves exercise capacity in patients with pulmonary hypertension. [2022]
Effects of cardiopulmonary rehabilitation on pulmonary arterial hypertension: A prospective, randomized study. [2022]
Effectiveness and safety of a simple home-based rehabilitation program in pulmonary arterial hypertension: an interventional pilot study. [2023]
Exploring a physiotherapy well-being review to deliver community-based rehabilitation in patients with pulmonary hypertension. [2023]
Does pulmonary rehabilitation reduce peripheral blood pressure in patients with chronic obstructive pulmonary disease? [2022]
A review of ongoing trials in exercise based rehabilitation for pulmonary arterial hypertension. [2023]
Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial. [2021]
Effectiveness of a Home-Based Pulmonary Rehabilitation Program in Veterans. [2022]
Feasibility and effects of a home-care rehabilitation program in patients with chronic obstructive pulmonary disease. [2019]
A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: rationale and methods. [2018]
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