Remote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension

University of Calgary

Overview

This study will determine the feasibility of a mobile application-based home exercise rehabilitation program for patients with pulmonary hypertension.

Pulmonary rehabilitation programs that incorporate exercise training are an important component of optimal medical care for pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), which improves exercise performance, quality of life, and may even modify disease progression. To date, no studies have utilized mobile health (mHealth) technology to provide exercise program interventions in the pulmonary hypertension population. Leveraging mobile technology, such as smartphones or tablets, to administer a home-based exercise rehabilitation program could improve patient access, satisfaction, and participation, while providing sustained physiologic benefits and incurring major cost savings compared to inpatient or outpatient-based supervised programs. This study hypothesis is that a home-based exercise program delivered by a mobile app will be feasible and safe for PAH/CTEPH patients. The secondary outcomes assessed will explore whether there are changes in exercise capacity, health-related quality of life, and right ventricular function, compared to standard care.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Pulmonary Hypertension

Interventions

Exercise InterventionBEHAVIORAL

The Ethica mobile app will provide a daily alert accompanied by a short educational statement about PAH, disease self-management tips, dietary and nutritional advice, goal setting, and a motivational statement to encourage patients. Participation with each session will be assessed by a mobile app-embedded survey administered at the end of the day. Patients will be presented with weekly alerts to complete validated patient-reported quality of life questionnaires using the EmPHasis-10 and the Living with Pulmonary Hypertension Questionnaire, as well as the PRAISE self-efficacy score for pulmonary rehabilitation. The app will also ask patients to report their WHO/NYHA functional class every week. Using in-app buttons, participants can log adverse events associated with each exercise session.

Standard CareBEHAVIORAL

Participants will be provided usual care administered at the PH clinic at the University of Calgary and no supervised exercise session will be performed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years old. Either 2 OR 3 2. Diagnosis of PAH by a right heart catheterization with documented mean pulmonary arterial pressure (mPAP) ≥ 20 mmHg, pulmonary arterial wedge pressure ≤ 15 mmHg and a pulmonary vascular resistance (PVR) \> 3 wood units. 3. Diagnosis of CTEPH with mPAP ≥ 20 mmHg, pulmonary arterial wedge pressure ≤ 15 mmHg and a pulmonary vascular resistance (PVR) \> 3 wood units. Evidence of thromboembolic occlusion of the pulmonary arterial system. The patient must be deemed inoperable for, or have persistent pulmonary hypertension after, thromboendarterectomy. 4. Must own a mobile smart phone or tablet and have internet access at home. 5. Stable doses of PAH medications for ≥3 months. Changes to diuretic doses or anticoagulation within 3 months are permitted. Exclusion Criteria: 1. High-risk PAH, defined as REVEAL 2.0 score ≥9 or high-risk according to the 2015 European Society of Cardiology/European Respiratory Society (ESC/ERS) guidelines table. 2. Syncope in previous 3 months. 3. Unstable coronary artery disease. * Canadian Cardiovascular Society Class ≥ II angina. * Myocardial infarction in the past 3 months. * Symptomatic coronary artery disease with ≥50% stenosis on angiogram. 4. Moderate obstructive lung disease defined as forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio \< 0.7 and FEV1 \< 70% predicted. 5. Active treatment for malignancy other than non-melanoma skin cancer in past 12 months. 6. Life expectancy \< 12 months. 7. Actively listed for lung transplantation. 8. Cognitive, sensory, or musculoskeletal limitation that precludes participation in an exercise program, according to the investigator.

Locations (1)

Peter Lougheed Centre (PLC), University of Calgary

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

Feasibility of the mobile application-based home exercise program

Feasibility will be defined as all of following: 1. Recruitment of 20 patients in an 10 month period (2 per month), 2. Consent ratio \>30% (number who consent/number of eligible patients) 3. Dropout rate \< 20% 4. Patient adherence to the exercise program \>50%. Adherence will be expressed as average number of sessions completed per week over a 3-month period. A total adherence of \>70% will be considered excellent, 50-70% will be considered acceptable

Time frame: 12 weeks

Secondary Outcomes

Adverse events

Safety will be determined by patient-reported adverse events and serious adverse events.

Time frame: 12 weeks

Change in six-minute walking distance (6MWD) from baseline (relative and absolute).

Measured according to American Thoracic Society guidelines for 6MWD

Time frame: Baseline, 12 weeks

Change in maximal oxygen consumption (V'O2 peak)

Measured by incremental symptom-limited cardiopulmonary exercise test.

Time frame: Baseline, 12 weeks

Change in oxygen pulse (O2 pulse)

Measured by incremental symptom-limited cardiopulmonary exercise test.

Time frame: Baseline, 12 weeks

Change in ventilatory efficiency (V'E/V'CO2 slope and nadir)

Measured by incremental symptom-limited cardiopulmonary exercise test.

Time frame: Baseline, 12 weeks

Change in echocardiographic markers of right ventricular size and function.

Data from ClinicalTrials.gov

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