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NCT Number: NCT06543745

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Arterial Hypertension Frailty Hypertension, Pulmonary Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsyvania

Philadelphia, Pennsylvania, 19103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-Resistance Training

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

Primary outcomes

  1. Adverse Events

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

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

  2. Feasibility of Recruitment

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

    Feasibility of recruitment will be assessed by measuring recruitment rates

  3. Feasibility of Study

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

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

  4. Short Performance Physical Battery (SPPB) and emPHasis-10 (E10) scores

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

    Investigators will use a change in score for SPPB and E10 scores, using Wilcoxon signed-rank test.

  5. Patient/ Caregiver Exit Interview

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

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: RESIST-PH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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