An interventional study of 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. and Blood draw in Pulmonary Arterial Hypertension, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Diagnostic
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.
After obtaining informed consent, patients will be scheduled for an in-person substudy baseline visit. The subject will have their vital signs checked, will complete the E10 questionnaire, have blood drawn, and will complete exercise testing:
an occlusion device (Kaatsu B2 model) will be applied to the thigh area and a wireless NIRS device (PortaMon, Artinis, The Netherlands) will be applied over their right gastrocnemius muscle and secured with strap. The participant will be seated in a chair and allowed to rest for up to 10 minutes, and then the participant will begin performing seated heel raises. Once comfortable with the maneuver, the occlusion device will be inflated to systolic blood pressure (SBP) + 50 mmHg for 5 minutes and the participant will be asked to resume the seated heel raises. Then the cuff will be deflated at the completion of the 5 minutes. This will be followed by a 10-minute rest period and then repeated (cuff inflation and exercises for another 5 minutes). The occlusion device will then be removed, and the patient will continue wearing the NIRS in the seated position for another 20 minutes to capture the recovery phase.
A post-exercise blood draw will completed during the recovery phase.
A certified exercise physiologist will demonstrate the at-home exercises to the participant and assess their strength level and observe them performing them ensuring proper form and technique. Each exercise will be performed in 3 sets of 15-15-15 repetitions. A handout will be given to the participant to be used as a resource during the 12 +/- 1 week period between visits.
Low-load resistance training exercises:
Seated heel raises: Starting from seated position in a chair, the participant will place both their feet on the floor. Next they will press down with the forefoot and toes to raise their heels up off the floor. Then, they will lower their heels back down and repeat. They will be asked to keep their toes down on the floor the entire time.
Depending on the participant's strength, this exercise will be upgraded to seated heel raises with resistance. Participant will be in seated position on chair and will have a weight placed on their thigh comfortably. Then heel raises will be performed as described above.
The next upgrade to this exercise will be standing double heel raises: Participants will be asked to stand near a wall/counter for balance support as needed. The participant will lift up onto the balls of their feet and then slowly lower their heels back to ground and repeat as needed.
The next upgrade to this exercise will be standing single heel raises: Participants will be asked to stand near a wall/counter for balance support as needed. The participant will lift one leg up, bending at the knee then lift up onto the ball of their foot that's on the ground. The participant will then slowly lower their heel back to the ground and repeat as needed.
Plantar flexion: While sitting on the floor or a mat, the participant will place the band around the ball of their foot and toes and pull back until they feel a gentle stretch. The participant will press down on the band using their ankles but keeping their toes relaxed. Then the participant will press down fully with the toes. To release let the band, the participant will pull the toes up first before releasing the ankle back to start. The band resistance will be upgraded as the participant progresses.
Sit to stand: The participant will start by scooting close to the front of the chair. Next, they will lean forward at their trunk and reach forward with their arms and rise to standing without using their hands to push off from the chair or other object. The participant will use their arms as a counter-balance by reaching forward when in sitting and lowering them as they approach standing.
Depending on patient's progress, this will be upgraded to box squats: with hands out in front of the participant, they will bend forwards at the hips, like they are going to sit back on a chair (get their hips as far away from their ankles as they can) and then return to standing. The participant will not sit; just tap the box with their bum. The participant will use the box or chair below as a target to hit as they squat down.
The next upgrade will be to loaded sit to stands: With the participant sitting on a sturdy chair and holding onto a medicine ball, or a weight, they will keep the weight close to the body. Keeping their back straight, the participant will lean forward at the hips (hip hinge) to get their weight over their feet. Then the participant will stand all the way up tall and make sure to keep their abdominals drawn in during the task.
Once each participant feels comfortable in performing the exercises independently, they will be provided with the resistance bands to go home. Each participant will be instructed to perform these exercises 3 times per week at their discretion and to log their completion in the exercise diary. The participant will then be scheduled for a follow-up visit mirroring the baseline visit at 12-weeks +/- 1 week. At the 12-week visit, the participant will also complete the E10 questionnaire and that will conclude their substudy participation.
699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Participating the main MUSCLE UP Study:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be asked to perform a series of exercises recommend by the National Institute on Aging Go4Life campaign, namely seated heel raise, plantar flexion, sit to stand, and box squats. They will wear the portamon device to measure muscle oxygenation and have blood drawn to measure adiponectin before performing the above exercises at home for 12 weeks, and then be measured with the portamon device and undergo another flood draw again after 12 weeks.
Device: 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. · Diagnostic Test: Blood draw
: 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
Also known as: Portamon device
: 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%.
Time frame: 12 Weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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