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

University of Calgary

Status: Withdrawn

Conditions: Pulmonary Hypertension

Treatments: Behavioral: Exercise Intervention; Behavioral: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04559516

REB20-0184

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Mobile application-based home exercise intervention

Experimental group

Description:

The exercise program will be administered over 12 weeks through the Ethica mobile app. Participants will perform exercise sessions at home guided by instructional video accessed via Ethica, six days per week. The program will include a combination of education, endurance, strength, and respiratory muscle training. The Ethica mobile app will provide a daily alert and a daily exercise video. There will be background monitoring of step counts and actigraphy will be monitored for one week intervals at baseline, at week six, and at week twelve.

Treatment:

Behavioral: Exercise Intervention

Standard care

Active Comparator group

Description:

No supervised exercise session will be performed. Symptoms and quality of life will be monitored in the same manner as the intervention group, and participants will receive the same educational message alerts through the Ethica app as the exercise intervention group.

Treatment:

Behavioral: Standard Care