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

N/AActive Not RecruitingNCT06543745

University of Pennsylvania20 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension Frailty

Interventions

Low-Resistance TrainingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsyvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Adverse Events

Safety will be assessed by way of the incidence of serious adverse events.

Time frame: Between baseline and 12-week follow-up

Feasibility of Recruitment

Feasibility of recruitment will be assessed by measuring recruitment rates

Time frame: Through study completion, an average of twice per year

Feasibility of Study

Feasibility of the study will be assessed by measuring retention rates.

Time frame: 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.

Time frame: 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.

Time frame: Upon conclusion of the 12-week follow-up

Data from ClinicalTrials.gov

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