Urban exercise program for patients with pulmonary hypertension

Rehabilitation in Pulmonary Hypertension: Effects of an Urban-training Program.

This study tests whether an urban exercise program can help people with pulmonary hypertension stay active and improve their health after completing a rehabilitation program.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Hospital Clinic of Barcelona (Academic / other)
• Locations: 1 site (Barcelona)
• Trial ID: NCT05523557 on ClinicalTrials.gov

What this trial studies

This project evaluates the efficacy of an urban exercise program following a rehabilitation program for patients with pulmonary hypertension (PH). It involves a randomized study with 80 participants, focusing on improvements in physical activity measured by accelerometry over 12 months. Secondary outcomes include bioimpedance, aerobic capacity, and various biomarkers related to vascular function and disease progression. The study aims to identify factors that contribute to the sustainability of the rehabilitation effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension who have completed a prior rehabilitation program.

Not a fit: Patients with other forms of pulmonary hypertension or those experiencing acute heart decompensation may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could help maintain and enhance physical activity levels in patients with pulmonary hypertension, improving their overall quality of life.

How similar studies have performed: Previous studies have shown positive outcomes with exercise-based rehabilitation in pulmonary hypertension, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years;
* New York Health Association (NYHA) II-III functional class;
* PAH or CTEPH diagnosed by right heart catheterization, evidencing: mean pulmonary arterial pressure (PAPm) ≥25 mmHg; pulmonary wedge pressure (PCWP) ≤15 mmHg; and pulmonary vascular resistance (PVR) ≥240 din/s/cm5 or 3 woods unit (WU);
* Patients with optimized PH targeted treatment, including intensified diuretic treatment and who have remained stable for at least 2 months before entering the study (no changes in medical treatment are expected throughout the 12-week study period);
* Patients who already finished a 3-months rehabilitation program;
* Be able to understand and be willing to sign the informed consent form.

Exclusion Criteria:

* Patients with other forms of PH (groups 2, 3 or 5);
* Pregnancy;
* Patients with signs of right heart decompensation;
* Inability to exercise on a cycle ergometer or walking;
* Acute infection or fever;
* Any change in the treatment of the disease in the last 2 months;
* Acute ischemic heart disease, unstable angina pectoris, exercise-induced ventricular arrhythmias, decompensated heart failure;
* History or suspicion of inability to cooperate properly in the study.

Where this trial is running

Barcelona

• Hospital Clínic — Barcelona, Spain (Recruiting)

Study contacts

• Principal investigator: Isabel Blanco, MD, PhD — Hospital Clinic of Barcelona
• Study coordinator: Isabel Blanco, MD, PhD

Conditions Pulmonary Hypertension