Remote Exercise Program deliVery Using A Mobile Phone Application for Patients With Pulmonary Arterial Hypertension (REVAMP): a Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility of the mobile application-based home exercise program
研究概览
简要总结
This study will determine the feasibility of a mobile application-based home exercise rehabilitation program for patients with pulmonary hypertension.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Exercise Intervention (Behavioral)
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.
干预措施: Standard Care (Behavioral)
结局指标
主要结局
Feasibility of the mobile application-based home exercise program
时间窗: 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
次要结局
- Change in echocardiographic markers of right ventricular size and function.(Baseline, 12 weeks)
- Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP) from baseline.(Weekly for 12 weeks)
- Patient Satisfaction and Usability Questionnaire.(Weekly for 12 weeks)
- Change in PRAISE self-efficacy score.(Weekly for 12 weeks)
- Adverse events(12 weeks)
- Change in maximal oxygen consumption (V'O2 peak)(Baseline, 12 weeks)
- Change in oxygen pulse (O2 pulse)(Baseline, 12 weeks)
- Change in ventilatory efficiency (V'E/V'CO2 slope and nadir)(Baseline, 12 weeks)
- Change in EmPHasis-10 score from baseline.(Weekly for 12 weeks)
- Proportion of patients improving at ≥1 World Health Organization/New York Heart Association (WHO/NYHA) functional class.(Weekly for 12 weeks)
- Change in Living with Pulmonary Hypertension score from baseline.(Weekly for 12 weeks)
- Change in background step counts and/or actigraphy from baseline.(Baseline, 12 weeks)
- Change in six-minute walking distance (6MWD) from baseline (relative and absolute).(Baseline, 12 weeks)