Recruiting

mHealth-CArdiac REhabilitation

Sponsor:

NYU Langone Health

Code:

NCT06829160

Conditions

Ischemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Communication with exercise therapist

mHealth-CR

Wearable activity monitoring device

Study Details

Brief summary:

This is a multi-site phase II, 2:1 pragmatic randomized trial of 250 participants within the NYU Langone Health (NYULH) and Emory University Medical Center system to evaluate mobile health cardiac rehabilitation (mHealth-CR) in patients who meet clinical criteria for INOCA (ischemia and no obstructive coronary disease on imaging). Participants will be randomized to mHealth-CR or usual care. The study intervention takes place for 3 months which is the time period for most traditional CR programs.

The overall study goals are threefold: 1) to evaluate whether an mHealth-CR intervention that includes activity tracking, weekly counseling, and exercise documentation, improves health status (i.e., symptoms, function, and quality of life) in patients with INOCA at 3 months; 2) to evaluate effects of the mHealth-CR intervention vs. usual care on physical activity and exercise capacity, general health status, and depressive symptoms (secondary endpoints). We will also evaluate effects on primary and secondary outcomes at 6 months and 1 year; and 3) to characterize engagement and elucidate any factors that limit engagement.

Conditions

Ischemia

Study ID

NCT06829160

Start date

Mar 21, 2025

Status verified date

Apr, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 and over
  • Diagnosis of Ischemia with Non-Obstructive Coronary Arteries (INOCA) based on evidence of ischemia and/or ischemic symptoms, plus non-obstructive Coronary artery disease (CAD) on computed tomography (CT) or invasive angiography

Exclusion Criteria:

  • Seattle Angina Questionnaire (SAQ) = 100
  • Non-ambulatory
  • Pregnant
  • Moderate or severe cognitive impairment
  • Unable/willing to provide consent
  • Incarcerated
  • Unable to use mHealth
  • Severe osteoarthritis or joint replacement within 3 months
  • Parkinsons disease or other movement disorders
  • Regular use of walker
  • Life expectancy < 12 months
  • Clinical judgement concerning other safety or non-adherence issues
  • Unable to read and communicate in English since the app content is currently only available in English.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mHealth-Cardiac Rehabilitation (CR)

Participants in the mHealth-CR arm will receive daily therapist-directed activity and weekly phone calls, use a mHealth-CR app to track activity, heart rate and access educational materials, and use a wearable wrist activity monitoring device (such as Fitbit or Apple Watch).

active comparator: Usual Care

Participants in usual care arm will receive standard medical care as determined by their physician. They will also use a wearable wrist activity monitoring device.

Interventions

Communication with exercise therapist

A personalized exercise program will be designed. The assigned therapist will identify potential barriers to this plan and develop mitigation strategies. The assigned therapist will then make phone contact with participants weekly for the duration of the study. Exercise recommendations will be titrated during calls based on review of activity data.

mHealth-CR

mHealth-CR software (currently, from Corrie Health) will permit 1) participant data entry about exercise; 2) viewing of educational material pertinent to the condition.

Wearable activity monitoring device

Participants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.

Primary outcome measure

  • Change in Seattle Angina Questionnaire (SAQ) score [ Time Frame: Baseline, Month 3 ]
  • Change in Seattle Angina Questionnaire (SAQ) score [ Time Frame: Baseline, Month 12 ]
  • Weekly percent completion of the mHealth-CR program [ Time Frame: Month 3 ]

Central Contacts and Locations

Central contacts

Harmony Reynolds, MD

212-263-7751INOCA@nyulangone.org

John Dodson, MD

212-263-7751INOCA@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • INOCA
  • ANOCA
  • Ischemia
  • no obstructive coronary artery disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-04-23.