N/A
Completed N=49
A Mobile Health Intervention in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension · Idiopathic Pulmonary Arterial Hypertension · Heritable Pulmonary Arterial Hypertension · Associated Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT03069716 ↗
Enrolled (actual)
49
Serious AEs
4.8%
Results posted
Jun 2021
Primary outcomePrimary: Daily Step Count — 1409; -149 Steps
Summary
This study proposes the use of a mobile health intervention (utilizing a smart phone app) to encourage increased exercise in PAH patients. The study will be a randomized trial to examine feasibility of an mHealth (mobile device) Fitbit Charge HR and cell phone application intervention to improve step counts and increase participants activity level as compared to no intervention. The Fitbit Charge Heart Rate (HR) monitors activity and the cell phone application provides encouragement notifications to half the subjects while the other half do not receive encouragements.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Step Count |
1409; -149 | — |
| SECONDARY Six Minute Walk Test Distance |
3; -6 | — |
| SECONDARY Right Ventricle (RV) Strain |
-0.1; 0.4 | — |
| SECONDARY Percentage of Days Participants Met Their Daily Step Count Goal |
41; 24 | — |
| SECONDARY Daily Aerobic Time |
10; -16 | — |
| SECONDARY Change From Baseline at Week 12 in emPHasis-10 Questionnaire Score |
-3; 1.0 | — |
| SECONDARY Change From Baseline on the SF-36 Mental Component Summary (MCS) Score |
3.8; 1.5 | — |
| SECONDARY Change From Baseline to Week 12 in Borg Dyspnea Score |
-1.0; 0.0 | — |
| SECONDARY Resting Heart Rate |
0; 0 | — |
| SECONDARY Total Lean Mass |
0.1; 0.0 | — |
| SECONDARY Insulin Resistance |
0.3; 0.0 | — |
| SECONDARY BNP |
-2; 7 | — |
| SECONDARY Change From Baseline on the SF-36 Physical Component Summary (PCS) Score |
-0.8; -0.4 | — |
| SECONDARY Minutes of Moderate-vigorous Activity |
1.6; -0.6 | — |
| SECONDARY Visceral Fat Volume |
-67; 21 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 18 or older.
- Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
- Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included.
- Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan.
Exclusion Criteria
- Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition.
- Pregnancy.
- Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
- Forced vital capacity 1 diuretic adjustment in the prior three months.
- Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
Data sourced from ClinicalTrials.gov (NCT03069716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.