Understanding how low-load leg exercises affect muscle and blood flow in PAH patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants from the main MUSCLE UP-PH study at UPenn may join an optional substudy involving low-load resistance training of the lower extremities. The protocol uses a thigh cuff and a near-infrared device to measure changes in blood oxygenation during seated heel raises and the recovery period, alongside blood tests and safety monitoring. Exercise sessions are guided by a certified exercise physiologist and include multiple sets to assess strength and technique. Measurements are taken at baseline and after 12 weeks to evaluate changes in oxyhemoglobin and deoxyhemoglobin, plus recovery time after exercise. The study aims to illuminate how this training modality impacts tissue oxygen extraction in PAH patients.

Why it matters

Who can join: the full rules

Inclusion Criteria: Participating the main MUSCLE UP Study:

* Signed informed consent prior to initiation of any study mandated procedure.
* Male and female patient's ≥ 18 years of age.
* Diagnosis of PAH belonging to one of the following subgroups of Group 1 PH according to the updated clinical classification \[Humbert 2022\]
* Idiopathic (IPAH)
* Heritable (HPAH)
* Drugs or toxins induced
* Associated (APAH) with one of the following:
* Connective tissue disease;
* Human immunodeficiency virus (HIV) infection;
* Congenital heart disease; or
* Portopulmonary hypertension
* Diagnosis of PAH within 6 months of enrollment or diagnosis of PAH and on stable therapy for 3 months prior to enrollment
* Documented hemodynamic diagnosis of PAH by right heart catheterization (RHC), prior to enrollment showing:
* mPAP \> 20 mmHg; and
* PAWP or LVEDP ≤ 15 mmHg
* PVR \> 2 Wood units

Exclusion Criteria:

* Prior to enrollment, evidence of moderately severe obstructive ventilator defect with:
* FEV1/FVC ≤ 5th percentile; and
* FEV1 z-score \< -2.5
* Prior to enrollment, evidence of severe restrictive defect with
* TLC \< 5th percentile
* FEV1 z-score \< -4
* More than moderate aortic or mitral valve disease
* LVEF \< 40% within 1 year of screening
* Pregnancy

Where it's running

• University of Pennsylvania Hospital
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Nadine Al-Namaani, MD — University of Pennsylvania
• Study coordinator: Rebecca Gallagher Research Project Manager, MSEd
• Email: rebecca.lang@pennmedicine.upenn.edu
• Phone: 215-662-4088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.