Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension
- Conditions
- FrailtyPulmonary Arterial Hypertension
- Interventions
- Behavioral: Low-Resistance Training
- Registration Number
- NCT06543745
- Lead Sponsor
- University of Pennsylvania
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All subjects Low-Resistance Training All subjects will participate in the low-resistance training
- Primary Outcome Measures
Name Time Method Feasibility of Recruitment Through study completion, an average of twice per year Feasibility of recruitment will be assessed by measuring recruitment rates
Short Performance Physical Battery (SPPB) and emPHasis-10 (E10) scores Between baseline and 12-week follow-up Investigators will use a change in score for SPPB and E10 scores, using Wilcoxon signed-rank test.
Patient/ Caregiver Exit Interview 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.
Adverse Events Between baseline and 12-week follow-up Safety will be assessed by way of the incidence of serious adverse events.
Feasibility of Study Through study completion, an average of twice per year Feasibility of the study will be assessed by measuring retention rates.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pennsyvania
🇺🇸Philadelphia, Pennsylvania, United States