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Pulmonary Arterial HypertensionMUSCLE-UPSUBNCT07781709

Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Substudy

A study testing 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 people with Pulmonary Arterial Hypertension, run by University of Pennsylvania at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
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
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
30 Sep 2026to 1 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • More than moderate aortic or mitral valve disease
  • LVEF < 40% within 1 year of screening
  • Pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rebecca Gallagher Research Project Manager, MSEd contact

215-662-4088

rebecca.lang@pennmedicine.upenn.edu

United States1 site
  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104

    Nicole Denney, MS, 215-294-9755, Nicole.denney@Pennmedicine.upenn.edu

    Nadine Al-Namaani, MD

Other trials in United States

About this study

Official title: Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Penn Pilot Low Load Resistance Exercise Training Substudy

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.

Read the detailed description

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.

Being tested
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., Blood draw
Keywords
PAH, Exercise
Medical subject headings
Pulmonary Arterial Hypertension, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

    Also called Portamon 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 drawDiagnostic 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

Study groups in NCT07781709
Study groupRoleWhat they receive
Low resistance exercise interventionOtherParticipants 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%.

    Measured: 12 Weeks

Secondary outcomes (3)
  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion1 Jul 2029 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07781709
Sponsor's protocol ID
856202 Substudy
Other IDs
R01HL173533
Acronym
MUSCLE-UPSUB
Status last verified
Aug 2026
First submitted
17 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing 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 people with Pulmonary Arterial Hypertension, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rebecca Gallagher Research Project Manager, MSEd (215-662-4088, rebecca.lang@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in circulating level of adiponectin (ng/mL) pre- and post-exercise at baseline and at Week 12 (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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