Smartphone Delivered In-home Cardiopulmonary Rehabilitation

NCT02791685 | Completed

• 2 other identifiers: IRB000859382025P008772
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Disease; Coronary Artery Disease

Keywords

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (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.

  Week 12, Week 24

Secondary Outcomes (8)

• Change in Measure of Exercise Intensity (MET)

  Baseline, Week 12

• Change in Weight

  Baseline, Week 12

• Change in Body Mass Index (BMI)

  Baseline, Week 12

• Change in Blood Pressure

  Baseline, Week 12

• Change in A1c Level

  Baseline, Week 12

Study Arms (3)

Cardiac Rehabilitation - Movn Program

EXPERIMENTAL

Participants with coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD) who are eligible for cardiac rehabilitation will undergo an in-home program.

Behavioral: MULTIFIT Cardiac Rehabilitation

Pulmonary Rehabilitation - Movn Program

EXPERIMENTAL

Participants with stable chronic obstructive pulmonary disease (COPD) or hospitalized with an acute exacerbation of COPD will undergo an in-home pulmonary rehabilitation program.

Behavioral: Movn Pulmonary Rehabilitation

Traditional Cardiac Rehabilitation

ACTIVE COMPARATOR

Participants enrolled in a facility's traditional cardiac rehabilitation program will be seen at baseline and during a 12 and 24 week follow-up visit.

Behavioral: Standard of Care Cardiac Rehabilitation

Interventions

Movn Pulmonary Rehabilitation BEHAVIORAL

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.

Pulmonary Rehabilitation - Movn Program

Standard of Care Cardiac Rehabilitation BEHAVIORAL

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.

Traditional Cardiac Rehabilitation

MULTIFIT Cardiac Rehabilitation BEHAVIORAL

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.

Cardiac Rehabilitation - Movn Program

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Emory University: lead
• Atlanta VA Medical Center: collaborator

Study Sites (1)

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Related Publications (2)

• 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.

  PMID: 37700245 DERIVED

• 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.

  PMID: 30217377 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Amit J Shah, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 7, 2016
• Study Start: May 1, 2016
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)