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Cardiovascular DiseaseNCT02791685

Smartphone Delivered In-home Cardiopulmonary Rehabilitation

A study testing MULTIFIT Cardiac Rehabilitation and Movn Pulmonary Rehabilitation in people with Cardiovascular Disease and Coronary Artery Disease, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to determine if a remote cardiac or pulmonary rehabilitation program delivered via a smartphone application and regular telephone calls will lead to improved delivery of cardiac rehabilitation compared to usual care. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MULTIFIT Cardiac Rehabilitation and Movn Pulmonary Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
1 siteUnited States
Study dates
May 2016to 3 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet eligibility for cardiac rehabilitation program as defined by Centers for Medicare \& Medicaid Services (CMS); they may also have stable CAD and be referred for cardiac rehab by their provider.
  • Following acute myocardial infarction (within the preceding 12 months)
  • Coronary artery bypass grafting (CABG)
  • Current stable angina pectoris
  • Heart valve repair or replacement
  • Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
  • Heart or heart-lung transplant
  • Other diagnosis by specific physician referral

Who cannot join

  • Unstable angina
  • Resting systolic blood pressure >200 mm Hg or resting diastolic blood pressure >110 mm Hg
  • Significant drop (>=20 mm Hg) in resting systolic blood pressure from the patient's average level that cannot be explained by medications
  • Moderate to severe aortic stenosis
  • Acute systemic illness or fever
  • Uncontrolled atrial or ventricular arrhythmias
Show all 15Show fewer
  • Symptomatic congestive heart failure (stage C)
  • Third-degree heart block without pacemaker
  • Active pericarditis or myocarditis
  • Recent venous thromboembolism (VTE, as determined by physician)
  • Current Thrombophlebitis
  • Uncontrolled diabetes (A1c > 7.0 or as determined by physician)
  • Orthopedic problems that would prohibit exercise
  • Other by specific physician instruction
  • Peripheral vascular disease (PVD; symptomatic or that would prohibit exercise)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Atlanta VA Medical Center

    Atlanta, Georgia, 30033

Other trials in United States

About this study

The goal of this study is to determine if a remote cardiac or pulmonary rehabilitation program delivered via a smartphone application and regular telephone calls will lead to improved delivery of cardiac rehabilitation compared to usual care. This includes increased adherence for eligible veterans, increased program completion, improved patient outcomes as measured by functional capacity, improved patient compliance in monitoring symptoms, improved self-efficacy and knowledge in managing disease and, a decreased rate of hospitalization and re-admissions.

Read the detailed description

This project aims to determine if a smartphone-delivered cardiac rehabilitation (CR) program could show similar clinical outcomes to in-person programs at a low cost in a large population of patients. Investigators will also assess the feasibility of tailoring a virtual CR program to a small sample of COPD participants who also stand to benefit in the absence of an established pulmonary rehabilitation (PR) program.

This is a non-randomized clinical trial of participants at the Atlanta Veterans Affairs Medical Center with an applicable diagnosis for cardiac or pulmonary rehabilitation versus usual care during the study period. We will evaluate the outcomes related to smartphone-enabled home base cardiopulmonary rehabilitation in those who choose the intervention and those who opt into home-based CR, traditional CR, or those who decline. Data from the past 5 years will also be evaluated to obtain a baseline event rate.

Investigators seek to address the following:

  1. Determine whether a home-based cardiac or pulmonary rehabilitation program delivered through smartphones is feasible and improves functional status.
  2. Determine if education and lifestyle counseling lead to increased adherence with prescribed follow-up, pharmacotherapy, quality of life, self-efficacy and lifestyle changes.
  3. Determine if a home-based cardiac or pulmonary rehabilitation program reduces health system utilization, including ED visits and readmission rates.
Being tested
MULTIFIT Cardiac Rehabilitation, Movn Pulmonary Rehabilitation, Standard of Care Cardiac Rehabilitation
Keywords
Cardiac Rehabilitation
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MULTIFIT Cardiac RehabilitationBehavioural

    MULTIFIT is a cardiac rehabilitation program delivered by the Movn smartphone application that will provide risk factor modification, prescribed exercises, education and counseling. The application will track activity using a built-in accelerometer or through connected devices such as a Fitbit for daily physical activity and management. Weight and blood pressure (BP) will be tracked by manual input or through wireless scales and BP monitors. The program will last for 12 weeks.

  • Movn Pulmonary RehabilitationBehavioural

    Movn pulmonary rehabilitation is a program delivered by the Movn smartphone application that includes targeted educational content and prescribed exercises with mild resistance training in addition to walking and other cardiovascular exercises. The application will track activity using a built-in accelerometer or through connected devices such as a Fitbit for daily physical activity and management. Weight and blood pressure (BP) will be tracked by manual input or through wireless scales and BP monitors. The program will last for 12 weeks.

  • Standard of Care Cardiac RehabilitationBehavioural

    Standard cardiac rehabilitation involves a facility's standard rehabilitation practices. Participants will be seen at baseline and during a 12 and 24 week follow-up visit.

Study groups in NCT02791685
Study groupRoleWhat they receive
Cardiac Rehabilitation - Movn ProgramExperimentalParticipants with coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD) who are eligible for cardiac rehabilitation will undergo an in-home program.
Receives: Behavioral: MULTIFIT Cardiac Rehabilitation
Pulmonary Rehabilitation - Movn ProgramExperimentalParticipants with stable chronic obstructive pulmonary disease (COPD) or hospitalized with an acute exacerbation of COPD will undergo an in-home pulmonary rehabilitation program.
Receives: Behavioral: Movn Pulmonary Rehabilitation
Traditional Cardiac RehabilitationActive comparatorParticipants enrolled in a facility's traditional cardiac rehabilitation program will be seen at baseline and during a 12 and 24 week follow-up visit.
Receives: Behavioral: Standard of Care Cardiac Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Functional Capacity assessed by the Six Minute Walk Test (6MWT)

    The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

    Measured: Week 12, Week 24

Secondary outcomes (8)

  1. Change in Measure of Exercise Intensity (MET)

    An exercise test will be used to collect MET.

    Measured: Baseline, Week 12

  2. Change in Weight

    Weight will be measured in kilograms.

    Measured: Baseline, Week 12

  3. Change in Body Mass Index (BMI)

    Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.

    Measured: Baseline, Week 12

  4. Change in Blood Pressure

    Blood pressure is measured using a blood pressure cuff to the upper extremity. The top number, which is also the higher of the two numbers, measures the pressure in the arteries when the heart beats (systolic).The bottom number, which is also the lower of the two numbers, measures the pressure in the arteries between heartbeats (diastolic). Readings are measured as follows:

    Normal = systolic less than 120 and diastolic less than 80 Prehypertension = systolic 120 - 139 or diastolic 80 - 89 High Blood Pressure (Hypertension) Stage 1 = systolic 140 - 159 or diastolic 90 - 99 High Blood Pressure(Hypertension) Stage 2 = systolic 160 or higher or diastolic 100 or higher Hypertensive Crisis (Emergency care needed) systolic = higher than 180 or diastolic higher than 110

    Measured: Baseline, Week 12

  5. Change in A1c Level

    The A1C test is a blood test that provides information about a person's average levels of blood glucose, also called blood sugar, over the past 3 months.

    Levels are measured as follows:

    Normal = below 5.7 percent Diabetes = 6.5 percent or above Prediabetes = 5.7 to 6.4 percent

    Measured: Baseline, Week 12

  6. Change in Low-density Lipoprotein (LDL) Level

    LDL cholesterol is considered "bad" cholesterol because it contributes to plaque, a thick, hard deposit that can clog arteries and make them less flexible.

    Levels are measured as follows:

    < 100 mg/ dL = Optimal 100-129 mg/dL = Near optimal/above optimal 130-159 mg/dL = Borderline high 160-189 mg/dL = High >190 mg/dL = Very high

    Measured: Baseline, Week 12

  7. Change in Duke Activity Status Index (DASI) Score

    The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilizes self-reported physical work capacity to estimate peak metabolic equivalents. The DASI is scored by adding all activities performed together. A higher score indicates the ability to perform more physical activities.

    Measured: Baseline, Week 12

  8. Change in Patient Health Questionnaire (PHQ-9) Score

    The PHQ-9 is an instrument for screening, diagnosing, monitoring, and measuring the severity of depression.

    Score ranges from 5-9 indicate minimal depressive symptoms. Scores 10-14 may indicate minor depression, dysthymia, and mild major depression. Scores 15-19 indicate moderately severe, major depression. Scores greater than or equal to 20 indicate severe major depression.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion3 Mar 2022
  4. Study completion3 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02791685
Sponsor's protocol ID
IRB00085938
Other IDs
2025P008772
Status last verified
Jan 2026
First submitted
2 Jun 2016
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Harzand A, Alrohaibani A, Idris MY, Spence H, Parrish CG, Rout PK, Nazar R, Davis-Watts ML, Wright PP, Vakili AA, Abdelhamid S, Vathsangam H, Adesanya A, Park LG, Whooley MA, Wenger NK, Zafari AM, Shah AJ. Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial. BMC Cardiovasc Disord. 2023 Sep 12;23(1):453. doi: 10.1186/s12872-023-03471-w.

    PubMed 37700245

  • Harzand A, Witbrodt B, Davis-Watts ML, Alrohaibani A, Goese D, Wenger NK, Shah AJ, Zafari AM. Feasibility of a Smartphone-enabled Cardiac Rehabilitation Program in Male Veterans With Previous Clinical Evidence of Coronary Heart Disease. Am J Cardiol. 2018 Nov 1;122(9):1471-1476. doi: 10.1016/j.amjcard.2018.07.028. Epub 2018 Aug 4.

    PubMed 30217377

Questions about this trial

What is this clinical trial studying?

A study testing MULTIFIT Cardiac Rehabilitation and Movn Pulmonary Rehabilitation in people with Cardiovascular Disease and Coronary Artery Disease, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Functional Capacity assessed by the Six Minute Walk Test (6MWT) (time frame: Week 12, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02791685, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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