Back to resultsRemote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension (REVAMP)
Primary Purpose
Pulmonary Hypertension
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Intervention
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Rehabilitation, Mobile-based home exercise program
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old.
Either 2 OR 3
- 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.
- 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.
- Must own a mobile smart phone or tablet and have internet access at home.
- Stable doses of PAH medications for ≥3 months. Changes to diuretic doses or anticoagulation within 3 months are permitted.
Exclusion Criteria:
- 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.
- Syncope in previous 3 months.
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.
- 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.
- Active treatment for malignancy other than non-melanoma skin cancer in past 12 months.
- Life expectancy < 12 months.
- Actively listed for lung transplantation.
- Cognitive, sensory, or musculoskeletal limitation that precludes participation in an exercise program, according to the investigator.
Sites / Locations
- Peter Lougheed Centre (PLC), University of Calgary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile application-based home exercise intervention
Standard care
Arm 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.
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.
Outcomes
Primary Outcome Measures
Feasibility of the mobile application-based home exercise program
Feasibility will be defined as all of following:
Recruitment of 20 patients in an 10 month period (2 per month),
Consent ratio >30% (number who consent/number of eligible patients)
Dropout rate < 20%
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
Secondary Outcome Measures
Adverse events
Safety will be determined by patient-reported adverse events and serious adverse events.
Change in six-minute walking distance (6MWD) from baseline (relative and absolute).
Measured according to American Thoracic Society guidelines for 6MWD
Change in maximal oxygen consumption (V'O2 peak)
Measured by incremental symptom-limited cardiopulmonary exercise test.
Change in oxygen pulse (O2 pulse)
Measured by incremental symptom-limited cardiopulmonary exercise test.
Change in ventilatory efficiency (V'E/V'CO2 slope and nadir)
Measured by incremental symptom-limited cardiopulmonary exercise test.
Change in echocardiographic markers of right ventricular size and function.
Measured with 2-dimensional and 3-dimensional transthoracic echocardiography
Change in EmPHasis-10 score from baseline.
EmPHasis-10 is a simple 10-item disease-specific quality of life measurement. Scale 0-50. Higher EmPHasis-10 scores reflect worse quality of life.
Change in PRAISE self-efficacy score.
Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) score is a validated self-efficacy score designed for the pulmonary rehabilitation population and is composed of 15 items. Each item is scored from 1 to 4 with a total range from 15 to 60. Higher scores indicate higher levels of self-efficacy.
Change in Living with Pulmonary Hypertension score from baseline.
Living with Pulmonary Hypertension is a disease-specific quality of life score that is more widely validated than EmPHasis-10. Living with Pulmonary Hypertension questionnaire comprises 21 items and is responded to on a 6-point Likert scale ranging from 0 'No' to 5 'very much'. The total score ranges from 0 to 105. Higher scores indicate that the patients are more affected by their medical condition (worse quality of life).
Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP) from baseline.
NT-proBNP is a blood biomarker of right ventricular dysfunction.
Proportion of patients improving at ≥1 World Health Organization/New York Heart Association (WHO/NYHA) functional class.
WHO/NYHA functional class is a subjective measure of functional capacity and symptoms.
Patient Satisfaction and Usability Questionnaire.
This is a custom made questionnaire with qualitative open-ended questions and questions on a 5-point Likert scale from 1 (Very Dissatisfied) to 5 (Very Satisfied). Information will be used to refine the app and the exercise program for a subsequent trial.
Change in background step counts and/or actigraphy from baseline.
This will serve to monitor study groups for baseline activity level as well as overall increased activity according to allocation.
Full Information
NCT ID
NCT04559516
First Posted
September 4, 2020
Last Updated
November 4, 2022
Sponsor
University of Calgary
Collaborators
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT04559516
Brief Title
Remote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension
Acronym
REVAMP
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator moved to different institution.
Study Start Date
November 3, 2022 (Anticipated)
Primary Completion Date
November 3, 2022 (Anticipated)
Study Completion Date
November 3, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
University of Saskatchewan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary Rehabilitation, Mobile-based home exercise program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The principal investigator and co-investigator will be unaware of allocation until after the beginning of the exercise program. There will be no blinding after intervention begins, as is typical with studies of exercise intervention.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile application-based home exercise intervention
Arm Type
Experimental
Arm 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.
Arm Title
Standard care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Participants will be provided usual care administered at the PH clinic at the University of Calgary and no supervised exercise session will be performed.
Primary Outcome Measure Information:
Title
Feasibility of the mobile application-based home exercise program
Description
Feasibility will be defined as all of following:
Recruitment of 20 patients in an 10 month period (2 per month),
Consent ratio >30% (number who consent/number of eligible patients)
Dropout rate < 20%
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 Outcome Measure Information:
Title
Adverse events
Description
Safety will be determined by patient-reported adverse events and serious adverse events.
Time Frame
12 weeks
Title
Change in six-minute walking distance (6MWD) from baseline (relative and absolute).
Description
Measured according to American Thoracic Society guidelines for 6MWD
Time Frame
Baseline, 12 weeks
Title
Change in maximal oxygen consumption (V'O2 peak)
Description
Measured by incremental symptom-limited cardiopulmonary exercise test.
Time Frame
Baseline, 12 weeks
Title
Change in oxygen pulse (O2 pulse)
Description
Measured by incremental symptom-limited cardiopulmonary exercise test.
Time Frame
Baseline, 12 weeks
Title
Change in ventilatory efficiency (V'E/V'CO2 slope and nadir)
Description
Measured by incremental symptom-limited cardiopulmonary exercise test.
Time Frame
Baseline, 12 weeks
Title
Change in echocardiographic markers of right ventricular size and function.
Description
Measured with 2-dimensional and 3-dimensional transthoracic echocardiography
Time Frame
Baseline, 12 weeks
Title
Change in EmPHasis-10 score from baseline.
Description
EmPHasis-10 is a simple 10-item disease-specific quality of life measurement. Scale 0-50. Higher EmPHasis-10 scores reflect worse quality of life.
Time Frame
Weekly for 12 weeks
Title
Change in PRAISE self-efficacy score.
Description
Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) score is a validated self-efficacy score designed for the pulmonary rehabilitation population and is composed of 15 items. Each item is scored from 1 to 4 with a total range from 15 to 60. Higher scores indicate higher levels of self-efficacy.
Time Frame
Weekly for 12 weeks
Title
Change in Living with Pulmonary Hypertension score from baseline.
Description
Living with Pulmonary Hypertension is a disease-specific quality of life score that is more widely validated than EmPHasis-10. Living with Pulmonary Hypertension questionnaire comprises 21 items and is responded to on a 6-point Likert scale ranging from 0 'No' to 5 'very much'. The total score ranges from 0 to 105. Higher scores indicate that the patients are more affected by their medical condition (worse quality of life).
Time Frame
Weekly for 12 weeks
Title
Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP) from baseline.
Description
NT-proBNP is a blood biomarker of right ventricular dysfunction.
Time Frame
Weekly for 12 weeks
Title
Proportion of patients improving at ≥1 World Health Organization/New York Heart Association (WHO/NYHA) functional class.
Description
WHO/NYHA functional class is a subjective measure of functional capacity and symptoms.
Time Frame
Weekly for 12 weeks
Title
Patient Satisfaction and Usability Questionnaire.
Description
This is a custom made questionnaire with qualitative open-ended questions and questions on a 5-point Likert scale from 1 (Very Dissatisfied) to 5 (Very Satisfied). Information will be used to refine the app and the exercise program for a subsequent trial.
Time Frame
Weekly for 12 weeks
Title
Change in background step counts and/or actigraphy from baseline.
Description
This will serve to monitor study groups for baseline activity level as well as overall increased activity according to allocation.
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old.
Either 2 OR 3
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.
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.
Must own a mobile smart phone or tablet and have internet access at home.
Stable doses of PAH medications for ≥3 months. Changes to diuretic doses or anticoagulation within 3 months are permitted.
Exclusion Criteria:
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.
Syncope in previous 3 months.
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.
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.
Active treatment for malignancy other than non-melanoma skin cancer in past 12 months.
Life expectancy < 12 months.
Actively listed for lung transplantation.
Cognitive, sensory, or musculoskeletal limitation that precludes participation in an exercise program, according to the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Weatherald, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter Lougheed Centre (PLC), University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Remote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension
We'll reach out to this number within 24 hrs