Low-Resistance Training for Pulmonary Hypertension

(RESIST-PH Trial)

Overseen By Zara Dunefsky, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: PAH therapy

Disqualifiers: WHO class IV, COPD, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how low-resistance training can improve the well-being and daily function of people with pulmonary arterial hypertension (PAH). The focus is on whether this exercise can reduce frailty and enhance participants' quality of life. Individuals with stable PAH on consistent treatment might be suitable for this study. All participants will engage in the low-resistance training program. As an unphased trial, this study offers participants the chance to contribute to valuable research that could refine exercise recommendations for PAH patients.

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 PAH therapy for at least 3 months before joining.

What prior data suggests that low-resistance training is safe for people with pulmonary arterial hypertension?

Research has shown that exercise, including gentle exercise, is generally safe for people with pulmonary hypertension (PH). Studies have found that exercise can enhance patients' exercise capacity, heart and lung fitness, and overall quality of life.

However, exercise is not entirely without risk. Some studies suggest careful monitoring, especially for those with more severe conditions.

Overall, gentle exercise is typically well-tolerated and can complement medical treatment to improve health in people with pulmonary arterial hypertension (PAH). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about low-resistance training for pulmonary hypertension because it offers a non-pharmacological approach to managing this condition. Unlike standard treatments, which often rely on medications to relax blood vessels and reduce pressure, low-resistance training focuses on improving cardiovascular health through gentle physical activity. This method could potentially enhance exercise capacity and quality of life for patients without the side effects commonly associated with drugs. Moreover, it empowers patients to take an active role in their own care through a sustainable lifestyle change.

What evidence suggests that low-resistance training might be an effective treatment for pulmonary hypertension?

Studies have shown that low-resistance training can greatly improve exercise ability and quality of life for people with pulmonary hypertension, a condition characterized by high blood pressure in the lungs. This exercise helps the heart and lungs work better together to supply oxygen during physical activity. Research also shows it can boost muscle strength and breathing, making daily tasks easier. This training is safe for these patients and can help blood flow more easily through the lungs. Overall, low-resistance training appears to be a promising way to enhance health and well-being in people with pulmonary arterial hypertension. ^{1 2 3 6 7}

Who Is on the Research Team?

Nadine Al-Naamani, MD, MS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals with pulmonary arterial hypertension (PAH) who are experiencing frailty. The study aims to include those who can safely perform low-resistance exercises and are looking to improve their quality of life.

Inclusion Criteria

I have been on stable treatment for pulmonary arterial hypertension for 3 months.

I have been diagnosed with PAH related to a specific cause.

Exclusion Criteria

World Health Organization (WHO) functional class IV

I was hospitalized within the last 4 weeks.

Left ventricular ejection fraction < 40% (via transthoracic echocardiogram (TTE) within one year of screening)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline in-person visit where quality of life and physical performance are assessed, and low-resistance training exercises are demonstrated

1 week

1 visit (in-person)

Home Exercise Training

Participants perform low-resistance training exercises at home as instructed

12 weeks

Follow-up

Participants return for a follow-up in-person visit where quality of life and physical performance are reassessed, and exit interviews are conducted

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Low-Resistance Training

Trial Overview The focus of the trial is on the effects of low-resistance training on patients with PAH. It seeks to determine if this type of exercise can reduce frailty and enhance overall well-being.

How Is the Trial Designed?

Group I: All subjects Experimental Treatment 1 Intervention

All subjects will participate in the low-resistance training

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Historically, exercise training was not recommended for patients with pulmonary hypertension due to concerns about safety and potential drops in cardiac output during exertion.

Recent evidence suggests that exercise training is safe and effective for improving exercise capacity, peak oxygen consumption, and quality of life in pulmonary hypertension patients, indicating it should be included as part of their treatment plan alongside optimal medical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary hypertension and exercise training: a synopsis on the more recent evidences. Leggio, M., Fusco, A., Armeni, M., et al.[2019]

Exercise training has been shown to significantly improve exercise capacity, muscular function, quality of life, and potentially right ventricular function in pulmonary hypertension patients, based on a review of 784 patients across various studies.

Despite its effectiveness and safety, exercise training for pulmonary hypertension is not widely reimbursed, highlighting the need for healthcare support and the establishment of specialized rehabilitation programs to improve patient access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ERS statement on exercise training and rehabilitation in patients with severe chronic pulmonary hypertension. Grünig, E., Eichstaedt, C., Barberà, JA., et al.[2020]

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]

Exercise rehabilitation training (ERT) is a safe and effective adjuvant treatment for patients with pulmonary hypertension (PH), improving exercise capacity, muscle performance, and quality of life, as supported by a review of 12 randomized controlled trials.

Despite its benefits, there is still a need for standardized ERT protocols regarding modality, duration, intensity, and frequency, and future research should focus on long-term effects and the underlying mechanisms of ERT in PH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Rehabilitation Training in Patients With Pulmonary Hypertension: A Review. Dong, C., Li, Y.[2022]

Recent guidelines from the European Respiratory Society and European Society of Cardiology recommend supervised exercise and respiratory training as an important addition to medical treatment for pulmonary hypertension, highlighting its potential benefits.

Exercise training may improve outcomes in pulmonary hypertension through various mechanisms, and further research is needed to explore these effects and optimize training modalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training and Rehabilitation in Pulmonary Hypertension. Benjamin, N., Marra, AM., Eichstaedt, C., et al.[2018]

Regular exercise training has been shown to be safe and effective in improving quality of life and cardiorespiratory fitness in patients with pulmonary arterial hypertension (PAH), despite the limited number of studies available.

Emerging evidence suggests that specific training recommendations can be developed to enhance rehabilitation programs for PAH patients, addressing their unique physiological challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Exercise Interventions in Pulmonary Arterial Hypertension and Recommendations for Rehabilitation Programing. Ozemek, C., Berry, MJ., Arena, R.[2020]

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 above research results suggested that resistance training and IMT could enhance muscle performance, improve exercise capability, and respiratory function, ...

3. trialx.com trialx.com/clinical-trials/listings/315645/safety-and-impact-of-low-resistance-exercise-training-on-quality-of-life-in-pulmonary-arterial-hypertension/

Safety and Impact of Low Resistance Exercise Training on ... Low-resistance training is an evidence-based approach that may help patients improve their functional ability.

4. 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 arterial ...

5. jtd.amegroups.org jtd.amegroups.org/article/view/37628/html

Effectiveness and safety of exercise training and rehabilitation ... It is inferred that exercise training can reduce pulmonary vascular resistance, increase pulmonary circulation perfusion, and improve cardiopulmonary function.

6. publications.ersnet.org publications.ersnet.org/content/erj/40/1/84

Safety and efficacy of exercise training in various forms of ... Exercise training in PH is an effective but not a completely harmless add-on therapy, even in severely diseased patients, and should be closely monitored.

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

Physical exercise for pulmonary arterial hypertension ... Exercise training in addition to medical therapy may be highly effective in patients with CTD-associated PAH with respect to improvements in exercise capacity, ...