Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension (RESIST-PH)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Frailty; Pulmonary Arterial Hypertension
• Intervention / Treatment: Behavioral: Low-Resistance Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • University of Pennsyvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; All subjects will participate in the low-resistance training	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Safety will be assessed by way of the incidence of serious adverse events.	Between baseline and 12-week follow-up
Feasibility of Recruitment	Feasibility of recruitment will be assessed by measuring recruitment rates	Through study completion, an average of twice per year
Feasibility of Study	Feasibility of the study will be assessed by measuring retention rates.	Through study completion, an average of twice per year
Short Performance Physical Battery (SPPB) and emPHasis-10 (E10) scores	Investigators will use a change in score for SPPB and E10 scores, using Wilcoxon signed-rank test.	Between baseline and 12-week follow-up
Patient/ Caregiver Exit Interview	Each subject (both patients who participate in the study and their caregivers, separately) will be asked to review their experience with the study protocol, rating their satisfaction on a 5 point Likert scale (1 being Strongly Disagree, 5 being Strongly Agree) with the overall protocol, ease of exercises, acceptability of equipment and exercises. Higher scores (eg. agreement of a positive experience) mean a better outcome.	Upon conclusion of the 12-week follow-up

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Nadine Al-Naamani, MD, MS, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Pathological Conditions, Signs and Symptoms; Frailty; Pulmonary Arterial Hypertension
• Other Study ID Numbers: 855504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No