At-home Monitoring of Exercise Capacity for Pulmonary Hypertension

(DynAMITE Trial)

Overseen By Ryan j Anderson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Left heart disease, Chronic lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new app on the Apple Watch can track exercise ability in people with pulmonary arterial hypertension (PAH). Researchers aim to determine if participants can use the app at home to accurately measure walking distance and heart rate during a six-minute walk test (home-based six-minute walk test). The trial compares two groups: one starting new PAH medication and the other continuing their current medication. This trial suits those diagnosed with PAH who can complete a six-minute walk test. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance daily health management for PAH patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that the Walk.Talk.Track. app and Apple Watch are safe for monitoring exercise capacity?

Research shows that a six-minute walk test at home is generally safe for people with pulmonary hypertension. This test measures the distance walked in six minutes and can be conducted using a digital app. Studies have found this method safe, practical, and reliable for patients with pulmonary arterial hypertension.

One study found that using a digital app for this test is not only safe but also fairly accurate and helpful for doctors. No major safety issues have been reported when conducting the test at home. The test tracks heart rate, distance walked, and other health indicators without requiring a clinic visit.

Overall, current research supports the safety and usefulness of home-based six-minute walk tests, making it a promising option for managing pulmonary hypertension at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the at-home monitoring approach for pulmonary hypertension because it offers a new way to track exercise capacity through a simple, home-based 6-minute walk test. Unlike traditional methods that require frequent hospital visits, this approach allows patients to assess their condition in a comfortable and familiar environment, potentially leading to more consistent and accurate data. This method empowers patients by involving them directly in their care, making it easier to adjust treatments promptly and improving overall management of the condition.

What evidence suggests that this trial's methods could be effective for monitoring exercise capacity in pulmonary hypertension?

Research has shown that exercising at home can greatly benefit people with pulmonary arterial hypertension (PAH). One study found that home exercise increased the distance participants could walk in six minutes by an average of about 55 meters, marking a significant improvement. Another study demonstrated a 71-meter increase in walking distance after six months of home exercise. These findings suggest that home exercises can significantly enhance exercise capacity and benefit heart health in people with PAH. In this trial, participants will either start a new PAH medication or continue their previous regimen, with progress tracked using home tests like the six-minute walk test (6MWT). ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with WHO Group I Pulmonary Arterial Hypertension, including idiopathic, heritable forms and PAH associated with other conditions. Participants must be able to perform a 6-minute walk test and not have pulmonary hypertension due to heart disease, chronic lung disease, CTEPH, or unclear causes.

Inclusion Criteria

Do not meet exclusion criteria

I have been diagnosed with a specific type of high blood pressure in the lungs.

Exclusion Criteria

I cannot complete a 6-minute walk test.

I have high blood pressure in my lungs due to long-term lung disease.

I have been diagnosed with chronic blood clot-related lung high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Walk.Talk.Track. app and Apple Watch to monitor exercise capacity and heart rate during a 12-week period, with new or continued PAH medication

12 weeks

In-clinic visits and home-based monitoring

Follow-up

Participants are monitored for changes in 6-minute walk distance and heart rate recovery after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home-based 6 minute walk test

Trial Overview The study tests the accuracy of an app-based 6-minute walk test (WTT) using an Apple Watch in both clinic and home settings. It aims to see if this method can reliably measure exercise capacity and monitor changes after starting treatment in newly diagnosed patients.

How Is the Trial Designed?

Group I: Initiating a new PAH medication Experimental Treatment 1 Intervention

Participants will start a new PAH medication

Group II: Continuing previous PAH medication regimen Active Control 1 Intervention

Participants will continue the medication regimen that they were on prior to enrollment

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

PHaware

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

A 12-week pilot study involving 16 patients with pulmonary arterial hypertension (PAH) showed that outpatient exercise programs, including multidisciplinary rehabilitation and home walking, may improve hemodynamic function and quality of life.

The study found improvements in right ventricular function, pulmonary artery pressure, and muscle strength, indicating that exercise is feasible and safe for PAH patients, but further research is needed to confirm these benefits due to the small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The exercise in pulmonary arterial hypertension (ExPAH) study: A randomized controlled pilot of exercise training and multidisciplinary rehabilitation in pulmonary arterial hypertension. Chia, KSW., Shiner, CT., Brown, K., et al.[2022]

The incremental shuttle walking test effectively stratifies mortality risk in patients with pulmonary arterial hypertension (PAH), with a significant reduction in 1-year mortality observed as walking distance increases, from 32% at ≤30 meters to 1% at ≥430 meters.

This study analyzed data from 1,847 PAH patients and established specific distance thresholds for risk categorization, which can be integrated into existing risk assessment tools, demonstrating the test's potential as a simple and effective alternative to traditional maximal exercise testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximal Exercise Testing Using the Incremental Shuttle Walking Test Can Be Used to Risk-Stratify Patients with Pulmonary Arterial Hypertension. Lewis, RA., Billings, CG., Hurdman, JA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5337064/

Six-minute walk test in pulmonary arterial hypertension According to the latest ESC/ERS guidelines, a 6 MWD over 500 m indicates good prognosis, whereas a 6MWD less than 300 m indicates poor prognosis (11). There are ...

2. publications.ersnet.org publications.ersnet.org/content/errev/34/177/250102

Effectiveness and safety of home-based versus centre-based ... We included 19 studies. Compared with inactive controls, home-based exercise training improved the 6-min walk distance (mean difference (MD) 54.85 m, p<0.01) ...

3. journal.chestnet.org journal.chestnet.org/article/S0012-3692(22)01197-7/fulltext

Cardiac Effort to Compare Clinic and Remote 6-Minute Walk ... Results: Remote 6-min walk test distance was less than the clinic measurement, whereas there was no difference between clinic and remote testing ...

4. atsjournals.org atsjournals.org/doi/10.1164/rccm.201203-0480OC

The Minimal Important Difference in the 6-Minute Walk Test ... This study reports the minimal important difference for the 6MWT in PAH, thereby providing a framework for assessing clinical response to therapy.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8316895/

Effectiveness and safety of a simple home-based ... Physical training significantly improved 6MWT distance (by 71.38 ± 83.4 m after 6 months (p = 0.004), which remained increased after 12 months ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10805266/

Safety, feasibility and effectiveness of the remotely delivered ... Safety, feasibility and effectiveness of the remotely delivered Pulmonary Hypertension and Home-Based (PHAHB) physical activity intervention.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9707972/

Appraisal of digital home-based 6-Minute Walk Test for use ... Distance walked is the primary measurement outcome of the 6MWT, but the test can also include blood oxygen saturation, subjective effort, dyspnoea, and heart ...

8. medrxiv.org medrxiv.org/content/10.1101/2024.08.08.24311687v1

Safety, Feasibility, and Utility of Digital Mobile Six-Minute ... Conclusions App-based outpatient 6MWT is feasible, safe, reasonably accurate, likely clinically relevant, and reliable in PAH patients but long ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1053249814012960

Predicting outcomes in pulmonary arterial hypertension ... Improvement in the 6MWD was not associated with survival, but worsening of the 6MWD was strongly and significantly associated with poor prognosis.