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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04559516
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Calgary
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jason Weatherald, MD
Principal Investigator Affiliation	University of Calgary
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension

Additional Details

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.

Arms & Interventions

Arms

Experimental: Mobile application-based home exercise intervention

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.

Active Comparator: Standard care

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.

Interventions

Behavioral: - Exercise Intervention

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.

Behavioral: - Standard Care

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.