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

NCT04559516 | Withdrawn

• 1 other identifier: REB20-0184
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Rehabilitation; Mobile-based home exercise program

Outcome Measures

Primary Outcomes (1)

• Feasibility of the mobile application-based home exercise program

  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

  12 weeks

Secondary Outcomes (13)

• Adverse events

  12 weeks

• Change in six-minute walking distance (6MWD) from baseline (relative and absolute).

  Baseline, 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

Study Arms (2)

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.

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.

Behavioral: Standard Care

Interventions

Exercise Intervention BEHAVIORAL

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.

Mobile application-based home exercise intervention

Standard Care BEHAVIORAL

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

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• University of Saskatchewan: collaborator

Study Sites (1)

Peter Lougheed Centre (PLC), University of Calgary

Calgary, Alberta, T1Y 6J4, Canada

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jason Weatherald, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 23, 2020
• Study Start: November 3, 2022
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: November 7, 2022

Record last verified: 2020-05

Locations

CA (1)