Pulmonary HypertensionREVAMPNCT04559516
Remote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension
A study testing Exercise Intervention in people with Pulmonary Hypertension, run by University of Calgary at 1 site in Canada.
Trial summary
This study will determine the feasibility of a mobile application-based home exercise rehabilitation program for patients with pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2022to 3 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Peter Lougheed Centre (PLC), University of Calgary
Calgary, Alberta, T1Y 6J4
About this study
Official title: Remote Exercise Program deliVery Using A Mobile Phone Application for Patients With Pulmonary Arterial Hypertension (REVAMP): a Pilot Randomized Trial
This study will determine the feasibility of a mobile application-based home exercise rehabilitation program for patients with pulmonary hypertension.
Read the 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.
- Conditions
- Pulmonary Hypertension
- Being tested
- Exercise Intervention, Standard Care
- Keywords
- Pulmonary Rehabilitation, Mobile-based home exercise program
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
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 CareBehavioural
Participants will be provided usual care administered at the PH clinic at the University of Calgary and no supervised exercise session will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Mobile application-based home exercise intervention | Experimental | 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. Receives: Behavioral: Exercise Intervention |
| Standard care | Active comparator | 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. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (13)
Adverse events
Safety will be determined by patient-reported adverse events and serious adverse events.
Measured: 12 weeks
Change in six-minute walking distance (6MWD) from baseline (relative and absolute).
Measured according to American Thoracic Society guidelines for 6MWD
Measured: Baseline, 12 weeks
Change in maximal oxygen consumption (V'O2 peak)
Measured by incremental symptom-limited cardiopulmonary exercise test.
Measured: Baseline, 12 weeks
Change in oxygen pulse (O2 pulse)
Measured by incremental symptom-limited cardiopulmonary exercise test.
Measured: Baseline, 12 weeks
Change in ventilatory efficiency (V'E/V'CO2 slope and nadir)
Measured by incremental symptom-limited cardiopulmonary exercise test.
Measured: Baseline, 12 weeks
Change in echocardiographic markers of right ventricular size and function.
Measured with 2-dimensional and 3-dimensional transthoracic echocardiography
Measured: Baseline, 12 weeks
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.
Measured: Weekly for 12 weeks
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.
Measured: Weekly for 12 weeks
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).
Measured: Weekly for 12 weeks
Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP) from baseline.
NT-proBNP is a blood biomarker of right ventricular dysfunction.
Measured: Weekly for 12 weeks
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.
Measured: Weekly for 12 weeks
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.
Measured: Weekly for 12 weeks
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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start3 Nov 2022 (estimated)
- Primary completion3 Nov 2022 (estimated)
- Study completion3 Nov 2022 (estimated)
Why it stopped: Principal Investigator moved to different institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saskatchewan
- Responsible party
- Sponsor
- Investigators
- Jason Weatherald, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559516
- Sponsor's protocol ID
- REB20-0184
- Acronym
- REVAMP
- Status last verified
- May 2020
- First submitted
- 4 Sep 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Exercise Program deliVery Using A Mobile Phone Application for Patients With Pulmonary Arterial Hypertension (REVAMP): a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT04559516
- Acronym / sponsor ID
- REVAMP / REB20-0184
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Rehabilitation, Mobile-based home exercise program
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator moved to different institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Saskatchewan
- Study start
- 3 Nov 2022 (estimated)
- Primary completion
- 3 Nov 2022 (estimated)
- Study completion
- 3 Nov 2022 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile application-based home exercise intervention | Experimental | Behavioral: Exercise InterventionThe 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. |
| Standard care | Active comparator | Behavioral: Standard CareNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionThe 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. | Behavioural | Mobile application-based home exercise intervention |
| Standard CareParticipants will be provided usual care administered at the PH clinic at the University of Calgary and no supervised exercise session will be performed. | Behavioural | Standard care |
Primary outcome
Feasibility of the mobile application-based home exercise program
Time frame: 12 weeks
Feasibility will be defined as all of following: 1. Recruitment of 20 patients in an 10 month period (2 per month), 2. Consent ratio >30% (number who consent/number of eligible patients) 3. Dropout rate < 20% 4. 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
13 secondary outcomes
Adverse events
Time frame: 12 weeks
Change in six-minute walking distance (6MWD) from baseline (relative and absolute).
Time frame: Baseline, 12 weeks
Change in maximal oxygen consumption (V'O2 peak)
Time frame: Baseline, 12 weeks
Change in oxygen pulse (O2 pulse)
Time frame: Baseline, 12 weeks
Change in ventilatory efficiency (V'E/V'CO2 slope and nadir)
Time frame: Baseline, 12 weeks
Change in echocardiographic markers of right ventricular size and function.
Time frame: Baseline, 12 weeks
Change in EmPHasis-10 score from baseline.
Time frame: Weekly for 12 weeks
Change in PRAISE self-efficacy score.
Time frame: Weekly for 12 weeks
Change in Living with Pulmonary Hypertension score from baseline.
Time frame: Weekly for 12 weeks
Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP) from baseline.
Time frame: Weekly for 12 weeks
Proportion of patients improving at ≥1 World Health Organization/New York Heart Association (WHO/NYHA) functional class.
Time frame: Weekly for 12 weeks
Patient Satisfaction and Usability Questionnaire.
Time frame: Weekly for 12 weeks
Change in background step counts and/or actigraphy from baseline.
Time frame: Baseline, 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Weatherald, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Pulmonary Hypertension, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the mobile application-based home exercise program (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.