After completion of the Baseline study visit for the main study (MUSCLE UP-PH), participants at the University of Pennsylvania location will be invited to participate in an optional substudy. The substudy will implement a low-load resistance exercise training for the lower extremities, focusing primarily on the gastrocnemius muscles. The goal of this intervention is to understand how low-load resistance training will impact blood flow and oxygen tissue extraction on the lower legs.
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)
FEV1/FVC ≤ 5th percentile; and
FEV1 z-score < -2.5
Prior to enrollment, evidence of severe restrictive defect with
TLC < 5th percentile
Single group
Measurement of oxyhemoglobin and deoxyhemoglobin concentration pre and post- exercise at baseline and Week 12. Measurement of time to recovery of oxyhemglobin post-exercise at baseline and at Week 12.
Device: The investigators will measure oxy-hemoglobin and deoxyhemoglobin concentration using NIRS applied to the biceps and calf pre- and post- exercise at baseline and Week 12. Moreover, the investigators will measure time to recovery of oxy-hemglobin post-exercise at baseline and at Week 12. Time Frame: 12 weeks
Blood draw
Diagnostic test: The investigators will measure adiponectin levels using a solid phase sandwich ELISA (R\&D Systems, Inc., Minneapolis, MN) with a minimum detectable dose of 0.246 ng/mL and intra-assay variations (CV) 2.5%-4.7%.Time Frame: 12 Weeks
Difference in circulating level of adiponectin (ng/mL) pre- and post-exercise at baseline and at Week 12
The investigators will measure adiponectin levels using a solid phase sandwich ELISA (R\&D Systems, Inc., Minneapolis, MN) with a minimum detectable dose of 0.246 ng/mL and intra-assay variations (CV) 2.5%-4.7%.
Measurement of deoxyhemoglobin concentration pre and post-exercise at baseline and Week 12.
The investigators will measure deoxyhemoglobin concentration using NIRS applied to the calf pre- and post-exercise at baseline and Week 12.
Measurement of oxyhemoglobin recovery post exercise at Baseline and Week 12
The investigators will measure the time to recovery of oxyhemoglobin concentration post-exercise using NIRS applied to the calf at baseline and Week 12.
Measurement of oxyhemoglobin concentration pre and post- exercise at baseline and Week 12.
The investigators will measure oxy-hemoglobin concentration using NIRS applied to the calf pre- and post- exercise at baseline and Week 12.
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University of Pennsylvania
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
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