Remote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension
NCT ID: NCT04559516
Last Updated: 2022-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-11-03
2022-11-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of Saskatchewan
OTHER
University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Jason Weatherald, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Peter Lougheed Centre (PLC), University of Calgary
Calgary, Alberta, Canada
Countries
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Other Identifiers
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REB20-0184
Identifier Type: -
Identifier Source: org_study_id
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