Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension

NCT ID: NCT06543745

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-04
• Study Completion Date: 2026-03-01

Brief Summary

The purpose of the study is to learn more about how low-resistance training impacts frailty and the quality of life of people with pulmonary arterial hypertension (PAH). Low-resistance training is an evidence-based approach that may help patients improve their functional ability.

Detailed Description

Patients with pulmonary arterial hypertension and their caregivers will be asked to participate in the study. The study consists of a baseline in-person visit (week 1) where quality of life and physical performance will be assessed, and subjects will be shown low-resistance training exercises to perform at home. The exercises will then be performed at home, as instructed, for 12 weeks. At week 12, subjects return for a follow-up in-person visit, where quality of life and physical performance will be reassessed. Patients and caregivers will also be asked to participate in separate exit interviews, where investigators will ask how they felt about the resistance training.

Conditions

Pulmonary Arterial Hypertension; Frailty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All subjects

All subjects will participate in the low-resistance training

Group Type: EXPERIMENTAL

Low-Resistance Training

Intervention Type: BEHAVIORAL

The following 6 exercises will be performed in 3 sets of 15-15-15 repetitions, 3 times per week for 12 weeks:

Elbow Flexion, Elbow Extension, Lateral Hip Extensions, Hip Extensions, Knee Extensions, Wall push-ups

Interventions

Low-Resistance Training

The following 6 exercises will be performed in 3 sets of 15-15-15 repetitions, 3 times per week for 12 weeks:

Elbow Flexion, Elbow Extension, Lateral Hip Extensions, Hip Extensions, Knee Extensions, Wall push-ups

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of PAH: idiopathic, heritable, associated with connective tissue disease, congenital heart disease, human immunodeficiency virus, drug- or toxin, or portopulmonary hypertension
• On stable PAH therapy for 3 months

Exclusion Criteria

• World Health Organization (WHO) functional class IV
• Left ventricular ejection fraction < 40% (via transthoracic echocardiogram (TTE) within one year of screening)
• Moderate or severe concomitant lung disease: Chronic Obstructive Pulmonary Disease (COPD) or interstitial lung disease
• Enrollment in a clinical trial
• Recent hospitalization (within 4 weeks of screening)
• Inability to perform the Short Physical Performance Battery or wheelchair bound

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadine Al-Naamani, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsyvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zara Dunefsky, BA

Role: CONTACT

zara.dunefsky@pennmedicine.upenn.edu

215-294-9755

Rebecca Gallagher, MSEd

Role: CONTACT

rebecca.lang@pennmedicine.upenn.edu

215-662-4088

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

855504

Identifier Type: -

Identifier Source: org_study_id