Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07132788
Status
Recruiting
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Conditions

  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • blood draw — DIAGNOSTIC_TEST
    Research blood draw
  • Short Performance Physical Battery — DIAGNOSTIC_TEST
    test of physical performance, which involves measuring movement from sitting to standing, walking speed, and balance
  • Grip strength test — DIAGNOSTIC_TEST
    Measures grip strength
  • Six minute walk test — DIAGNOSTIC_TEST
    Measures distance walked in 6 minutes
  • Chest CT scan — RADIATION
    X-ray and computer technology takes detailed pictures of the organs and structures inside your chest
  • Dual-Energy X-ray Absorptiometry Scan — RADIATION
    Uses X-ray technology to measure the mineral density of your bones, and provides a ratio of fat tissue to lean mass (muscle) and bone
  • Activity monitoring — BEHAVIORAL
    A device worn on your non-dominant wrist which measures motion/ movement/ activity
  • 24 hour diet recall — BEHAVIORAL
    A research dietitian will contact you and ask you to provide details of what you ate over the previous 24 hours
  • Echocardiogram — DIAGNOSTIC_TEST
    Ultrasound technology to create moving images of your heart, valves, and chambers
  • Quality of Life Questionnaire (emPHasis 10) — BEHAVIORAL
    The emPHasis-10 is a pulmonary hypertension-specific questionnaire which is scored from 0-50 (with higher scores indicating worse quality of life.)
  • International Physical Activity Questionnaire Short Form (IPAQ-SF) — BEHAVIORAL
    The IPAQ-SF is a small set of questions to obtain comparable estimates of physical activity.
  • Low resistance exercise intervention — BEHAVIORAL
    Participants will be asked to perform a series of exercises recommend by the National Institute on Aging Go4Life campaign, namely hand grip, overhead arm raise, arm curl, wall push-ups, and chair dips.

Study Details

Patients with pulmonary arterial hypertension (PAH) are at increased risk of muscle loss and decreased physical activity. This study will aim to (1) understand the way in which muscle loss occurs in PAH, particularly the role of fat surrounding the heart, and (2) look at the impact muscle loss has on quality of life, daily physical activity, and hospitalizations in patients with PAH. The findings from this study could help identify potentially treatable factors that may improve the overall quality of life and physical functioning of patients with PAH. Subjects will be asked to attend a baseline visit where the following will be performed: * Measure your vital signs * Undergo a research blood draw, less than 4 tablespoons * Provide a urine pregnancy test (if applicable) * Review demographics, personal history, and medical history * Review current PAH medications * Complete questionnaires on how your PAH affects you * Complete a test of physical performance * Complete a grip strength test * Undergo an echocardiogram (Echo) * Complete a six-minute walk test * Undergo a Chest CT Scan * Undergo a scan of your body composition (DXA scan) * Obtain a weight and body composition measurement on the InBody Scale Subjects will also complete activity moniotring, two 24-hour diet recalls, and participate in remote follow-up visits every 6 months

Key Dates

Start date
May 1, 2025
Status verified
May 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Low resistance exercise intervention
    Participants will be asked to perform a series of exercises recommend by the National Institute on Aging Go4Life campaign, namely hand grip, overhead arm raise, arm curl, wall push-ups, and chair dips.

Primary Outcome Measure

Intake of food and nutrients [ Time Frame: One time at Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104
Nicole Denney, MS
[email protected]
Nadine Al-Naamani, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pennsylvania Hospital· Philadelphia, PA

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