An interventional study of Communication with exercise therapist and mHealth-CR in Ischemia, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
545 studies on the registry are indexed under Ischemia; 72 are open to participants now.
This study's planned enrollment of 250 is above the median of 74 across 356 interventional studies indexed under Ischemia.
Browse Ischemia studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Communication with exercise therapist · Behavioral: mHealth-CR · Behavioral: Wearable activity monitoring device
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.
Behavioral: Wearable activity monitoring device
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 software (currently, from Corrie Health) will permit 1) participant data entry about exercise; 2) viewing of educational material pertinent to the condition.
Participants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.
Change in Seattle Angina Questionnaire (SAQ) score
The SAQ measures disease-related health status (functional status and quality of life) and has a four-week recall period. The SAQ generates a summary score (scale 0-100, 100 = full health, 0 = worst health).
Time frame: Baseline, Month 3
Change in Seattle Angina Questionnaire (SAQ) score
The SAQ measures disease-related health status (functional status and quality of life) and has a four-week recall period. The SAQ generates a summary score (scale 0-100, 100 = full health, 0 = worst health).
Time frame: Baseline, Month 12
Weekly percent completion of the mHealth-CR program
Weekly engagement will be measured as the fraction of the following elements completed each week: exercise therapy-directed activities, daily entry of exercise data and rated perceived exertion (RPE); completed weekly phone call with exercise therapist; at least one communication with exercise therapist (outside weekly phone call); reviewing educational video/text (which will vary by week). Competition will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all activities completed) incorporating values for each activity.
Time frame: Month 3
Change in step count
Step count is measured on a continuous basis and data will be obtained from the wearable activity monitoring device.
Time frame: Week 1, Month 3
Change in step count
Step count is measured on a continuous basis and data will be obtained from the wearable activity monitoring device.
Time frame: Week 1, Month 12
Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Time frame: Baseline, Month 3
Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Time frame: Baseline, Month 12
Change in visual analogue scale (VAS) score
VAS indicates the general health status (VAS; ranges from 0-100). Higher scores indicating the better health status.
Time frame: Baseline, Month 3
Change in visual analogue scale (VAS) score
VAS indicates the general health status (VAS; ranges from 0-100). Higher scores indicating the better health status.
Time frame: Baseline, Month 12
Change in patient Health Questionnaire - 8 Items (PHQ-8) score
The PHQ-8 is a self-reported measure of depressive symptoms composed of 8 Likert type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day), that refer to the presence of that symptom during the previous 2 weeks. The PHQ-8 final score is obtained by adding the score for each of the items, ranging from 0 to 24 (higher scores corresponding to higher levels of depression).
Time frame: Baseline, Month 3
Change in patient Health Questionnaire - 8 Items (PHQ-8) score
The PHQ-8 is a self-reported measure of depressive symptoms composed of 8 Likert type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day), that refer to the presence of that symptom during the previous 2 weeks. The PHQ-8 final score is obtained by adding the score for each of the items, ranging from 0 to 24 (higher scores corresponding to higher levels of depression).
Time frame: Baseline, Month 12
Change in exercise time on treadmill stress test
The treadmill stress test measures how well the participants heart works during physical activity. This test will take about 30 minutes in total, with about 10-15 minutes spent exercising.
Time frame: Baseline, Month 3
Change in rose Dyspnea Scale (RDS) score
The RDS is a questionnaire that assesses how much shortness of breath a patient experiences during daily activities. The scale has four items indicating whether patients experience breathlessness with different activities (scores range from 0 to 4, with higher scores indicating dyspnea with milder activities).
Time frame: Baseline, Month 3
Change in rose Dyspnea Scale (RDS) score
The RDS is a questionnaire that assesses how much shortness of breath a patient experiences during daily activities. The scale has four items indicating whether patients experience breathlessness with different activities (scores range from 0 to 4, with higher scores indicating dyspnea with milder activities).
Time frame: Baseline, Month 12
Change in perceived Stress Scale 4 (PSS-4) score
The PSS-4 is a self-reported questionnaire consisting of four questions designed to measure how stressful a person perceives their life to be over the past month. Scores range from 0 to 16, with higher scores indicating greater perceived stress levels.
Time frame: Baseline, Month 3
Change in perceived Stress Scale 4 (PSS-4) score
The PSS-4 is a self-reported questionnaire consisting of four questions designed to measure how stressful a person perceives their life to be over the past month. Scores range from 0 to 16, with higher scores indicating greater perceived stress levels.
Time frame: Baseline, Month 12
Number of cardiovascular hospitalizations
Outcome measure will be assessed through review of the electronic health record (EHR).
Time frame: Month 12
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: harmony.reynolds@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to harmony.reynolds@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Jul 2027, 28 months after the start.
Of 71 non-industry interventional studies with no phase under Ischemia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 46. This study's planned 28 months is below that.
Counting every sponsor, half of 82 studies reached it within 33 months; a quarter within 16 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.