Exercise for Pulmonary Arterial Hypertension

Overseen By Claire E Child, DPT, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Washington

Must be taking: PAH medications

Must not be taking: Intravenous inotropes

Disqualifiers: Hypertension, Liver disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a home exercise program can assist individuals with Pulmonary Arterial Hypertension (PAH) who are beginning sotatercept treatment. Sotatercept is a medication believed to help treat PAH, a condition that causes high blood pressure in the arteries of the lungs. Participants will follow a personalized exercise routine at home, using a fitness tracker and oxygen monitor, for 24 weeks. This trial suits those with PAH who have been stable on their current treatments for over 90 days and are ready to start sotatercept therapy. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires that you continue taking your current medications for pulmonary arterial hypertension (PAH) throughout the study.

What prior data suggests that this exercise program is safe for patients with pulmonary arterial hypertension?

Past studies have shown that home-based exercise programs for people with pulmonary arterial hypertension (PAH) are safe. These programs improve fitness and overall health. Research indicates that exercise training for those with PAH can significantly enhance their exercise capacity without major safety concerns.

The studies also demonstrate that exercising at home is as safe and effective as attending a gym or rehab center. This makes home workouts a viable option for those who prefer them or cannot access a gym. Overall, evidence suggests that these exercise programs are well-tolerated by people with PAH, with no serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Pulmonary Arterial Hypertension (PAH), which typically involve medications like vasodilators and endothelin receptor antagonists, this new approach combines a tailored home exercise program with the medication sotatercept. Researchers are excited because this method not only targets PAH through medication but also incorporates a personalized fitness plan monitored by a wrist-worn fitness tracker and oxygen saturation monitoring. This dual approach aims to enhance physical endurance and improve heart and lung function more effectively than medication alone, potentially offering a more comprehensive treatment strategy for patients with PAH.

What evidence suggests that this home exercise program is effective for pulmonary arterial hypertension?

Studies have shown that exercise can greatly enhance exercise capacity and overall quality of life for people with pulmonary hypertension (high blood pressure in the lungs). Research indicates that home-based exercise is both safe and effective, helping patients improve their physical abilities. Participants in these exercise programs have shown improvements in tests like the 6-minute walk distance (which measures physical endurance), oxygen utilization, and peak power. Notably, exercising at home proves as effective as attending a center and does not worsen the condition. This trial will evaluate the effectiveness of a tailored, progressive home exercise program for patients with pulmonary arterial hypertension (PAH), incorporating a wrist-worn fitness tracker and oxygen saturation monitoring, to assess its potential benefits as part of the treatment plan. ^{2 3 4 6 7}

Who Is on the Research Team?

Mary Beth Brown, PT, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Pulmonary Arterial Hypertension (PAH) who are stable on PAH therapy for more than 90 days and need to start sotatercept treatment. Participants must be able to follow the study schedule, consent to it, and engage in a home exercise program. Excluded are those with other types of pulmonary hypertension, certain heart conditions, uncontrolled high blood pressure, recent serious cardiovascular events or procedures.

Inclusion Criteria

Baseline RHC documenting minimum PVR of ≥ 5 WU and PCWP or left ventricular end-diastolic pressure of ≤ 15 mmHg

Ability to adhere to study visit schedule and understand and comply with all protocol requirements

Ability to understand and provide written informed consent

Exclusion Criteria

My condition is classified under PH WHO Groups 2, 3, 4, or 5.

Baseline platelet count < 50,000/mm3

Pregnant or breastfeeding females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sotatercept therapy and engage in a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring

24 weeks

Baseline and final in-person visits, remote monitoring at two interim assessment timepoints

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Measurement fidelity for the innovative 'remote Six Minute Walk Test (6MWT)'

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Home exercise program

Trial Overview The study tests a combination of sotatercept medication and a tailored home exercise program monitored remotely using fitness trackers and oxygen saturation devices over 24 weeks. The aim is to see how this combined approach affects patients with PAH.

How Is the Trial Designed?

Group I: Exercise Arm Experimental Treatment 1 Intervention

Patients with PAH on sotatercept plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

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]

A 12-week home-based physiotherapy program significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH), as evidenced by a notable increase in the 6-minute walk test (6MWT) distance by 51.8 meters after the program and 75.5 meters at a 6-month follow-up.

Participants in the physiotherapy group also showed significant increases in daily physical activity levels, particularly in low-intensity and moderate-intensity activities, while the control group did not experience any improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individually tailored home-based physiotherapy program makes sustainable improvement in exercise capacity and daily physical activity in patients with pulmonary arterial hypertension. Butāne, L., Spilva-Ekerte, L., Šablinskis, M., et al.[2022]

A 12-week pilot study involving 16 patients with pulmonary arterial hypertension (PAH) showed that outpatient exercise programs, including multidisciplinary rehabilitation and home walking, may improve hemodynamic function and quality of life.

The study found improvements in right ventricular function, pulmonary artery pressure, and muscle strength, indicating that exercise is feasible and safe for PAH patients, but further research is needed to confirm these benefits due to the small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The exercise in pulmonary arterial hypertension (ExPAH) study: A randomized controlled pilot of exercise training and multidisciplinary rehabilitation in pulmonary arterial hypertension. Chia, KSW., Shiner, CT., Brown, K., 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.

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]

This randomized controlled trial will assess the effects of an 8-week exercise program on muscle power and mass in patients with pulmonary artery hypertension (PAH), involving at least 48 participants.

The study aims to evaluate various health outcomes, including exercise capacity and quality of life, which will help understand the benefits of exercise in managing PAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and Design of a Randomized Controlled Trial Evaluating Whole Muscle Exercise Training Effects in Outpatients with Pulmonary Arterial Hypertension (WHOLEi+12). Sanchis-Gomar, F., González-Saiz, L., Sanz-Ayan, P., et al.[2022]

A 12-week text message-based intervention significantly increased daily step counts in patients with pulmonary arterial hypertension (PAH), with an average increase of 1,409 steps compared to a decrease of 149 steps in the control group.

The intervention also led to improvements in quality of life and reductions in visceral fat, suggesting that mobile health strategies can effectively promote physical activity in PAH patients, although no significant change was observed in the six-minute walk test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention to Increase Physical Activity in Pulmonary Arterial Hypertension. Hemnes, AR., Silverman-Lloyd, LG., Huang, S., et al.[2022]

A specialized exercise training and rehabilitation program is recommended as an effective add-on treatment for patients with pulmonary arterial hypertension, showing significant improvements in symptoms, exercise capacity, and quality of life across over 470 patients in various studies.

The safety profile of these exercise programs is acceptable, with some studies indicating excellent survival rates over 1 to 2 years, although most studies had small sample sizes and were not designed to measure long-term clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of rehabilitation and reactivation: pulmonary hypertension. Marra, AM., Egenlauf, B., Bossone, E., et al.[2015]

A 6-week outpatient exercise training program significantly improved exercise tolerance and health-related quality of life in two individuals with pulmonary arterial hypertension (PAH), with no adverse effects reported.

Both subjects showed notable increases in oxygen consumption and distance walked in the six-minute walk test, indicating enhanced aerobic capacity and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in patients with pulmonary arterial hypertension: a case report. Shoemaker, MJ., Wilt, JL., Dasgupta, R., et al.[2021]

A 16-week home exercise training program was feasible and well-tolerated in 9 children and adolescents with low-risk pulmonary arterial hypertension (PAH), with no adverse events reported.

Participants showed significant improvements in exercise capacity, including increased treadmill running distance and oxygen consumption at the anaerobic threshold, suggesting that home-based training can be beneficial for young patients with PAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Exercise Training in Children and Adolescents with Pulmonary Arterial Hypertension: A Pilot Study. Zöller, D., Siaplaouras, J., Apitz, A., et al.[2018]

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. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666668525000011

Physical exercise for pulmonary arterial hypertension ... They found an improvement of 48.52m in 6MWD, a 2.07 mL/kg/min higher mean peak VO2, and 9.6Watt higher peak power in the exercise training group. A randomised ...

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

Effectiveness and safety of home-based versus centre-based ... Improvements in clinical outcomes were comparable between home-based and centre-based interventions. No clinical worsening or exercise training-related severe ...

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

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

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10805266/

Safety, feasibility and effectiveness of the remotely delivered ... Effectiveness and safety of a simple home-based rehabilitation program in pulmonary arterial hypertension: an interventional pilot study.