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

Trial Summary

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 data supports the effectiveness of the treatment Low-Resistance Training for Pulmonary Hypertension?

Research shows that exercise training, including low-resistance training, can improve symptoms, exercise capacity, and quality of life in patients with pulmonary hypertension. Studies have demonstrated that such training is safe and beneficial when added to medical treatment. ^{1 2 3 4 5}

Is low-resistance training safe for people with pulmonary hypertension?

Research shows that exercise training, including low-resistance training, is generally safe for people with pulmonary hypertension when it is supervised and closely monitored. Studies have reported improvements in symptoms and quality of life, with an acceptable safety profile. ^{1 3 4 5 6}

How does Low-Resistance Training differ from other treatments for pulmonary hypertension?

Low-Resistance Training is unique because it involves a specialized exercise program that is safe and effective for improving exercise capacity and quality of life in pulmonary hypertension patients, unlike traditional treatments that primarily focus on medication. This approach is novel as it was historically not recommended for these patients, but recent studies show it can be a beneficial add-on to medical therapy. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of the study is to learn more about how low-resistance training impacts frailty and the quality of life of people with pulmonary arterial hypertension (PAH). Low-resistance training is an evidence-based approach that may help patients improve their functional ability.

Research Team

Nadine Al-Naamani, MD, MS

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Principles of rehabilitation and reactivation: pulmonary hypertension. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Pulmonary hypertension and exercise training: a synopsis on the more recent evidences. [2019]

3. England pubmed.ncbi.nlm.nih.gov

ERS statement on exercise training and rehabilitation in patients with severe chronic pulmonary hypertension. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Exercise Training and Rehabilitation in Pulmonary Hypertension. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A Review of Exercise Interventions in Pulmonary Arterial Hypertension and Recommendations for Rehabilitation Programing. [2020]

6. Australia pubmed.ncbi.nlm.nih.gov

Exercise Rehabilitation Training in Patients With Pulmonary Hypertension: A Review. [2022]