Clinical trial NCT04559516: Remote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension
Official title: Remote Exercise Program deliVery Using A Mobile Phone Application for Patients With Pulmonary Arterial Hypertension (REVAMP): a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Rehabilitation
Mobile-based home exercise program
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Saskatchewan
First posted: 2020-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the mobile application-based home exercise program
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 12 weeks
measure: Change in six-minute walking distance (6MWD) from baseline (relative and absolute).
timeFrame: Baseline, 12 weeks
measure: Change in maximal oxygen consumption (V'O2 peak)
timeFrame: Baseline, 12 weeks
measure: Change in oxygen pulse (O2 pulse)
timeFrame: Baseline, 12 weeks
measure: Change in ventilatory efficiency (V'E/V'CO2 slope and nadir)
timeFrame: Baseline, 12 weeks
measure: Change in echocardiographic markers of right ventricular size and function.
timeFrame: Baseline, 12 weeks
measure: Change in EmPHasis-10 score from baseline.
timeFrame: Weekly for 12 weeks
measure: Change in PRAISE self-efficacy score.
timeFrame: Weekly for 12 weeks
measure: Change in Living with Pulmonary Hypertension score from baseline.
timeFrame: Weekly for 12 weeks
measure: Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP) from baseline.
timeFrame: Weekly for 12 weeks
measure: Proportion of patients improving at ≥1 World Health Organization/New York Heart Association (WHO/NYHA) functional class.
timeFrame: Weekly for 12 weeks
measure: Patient Satisfaction and Usability Questionnaire.
timeFrame: Weekly for 12 weeks
measure: Change in background step counts and/or actigraphy from baseline.
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre (PLC), University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jason Weatherald, MD
role: PRINCIPAL_INVESTIGATOR
References: