Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction (AMI)
• Interventions: Behavioral: Home-based physical therapy; Behavioral: Usual Care

• Registration Number: NCT02804906
• Lead Sponsor: NYU Langone Health

Brief Summary

This pilot feasibility study will test whether a home-based cardiac rehabilitation intervention, using physical therapist visits combined with mobile health technology, will prevent decline in high-risk patients post acute myocardial infarction (AMI). Participants will be randomized to either an intervention arm (home-based physical therapy), or a control (usual care) arm. Prior to discharge, participants in the intervention arm will receive a 1-hour educational session by a research physical therapist that includes information on cardiac risk factor management, postoperative recovery, education on medication adherence, and a prescription for home exercise that is tailored to each patient's baseline abilities and limitations. Participants assigned to the control arm will receive a 30-minute counseling session on risk factor modification prior to discharge, in addition to usual care post-AMI.

Detailed Description

All participants enrolled in this research study will receive the FDA-approved FitBit Flex, a wearable activity monitoring device which will objectively measure physical activity and sedentary behavior in the period post-hospital discharge. Daily activity monitoring will include: number of steps, distance traveled, calories burned, number of active minutes.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Primary Completion: 2018-12-14
• Study Completion: 2019-01-14
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Clinical diagnosis of acute myocardial infarction (AMI).

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Exclusion Criteria

• moderate to severe cognitive impairment; non-ambulatory
• severe heart failure (NYHA Class IV); decisional impairment as assessed by the University of California
• San Diego Brief Assessment of Capacity to Consent (UBACC) 22, if the RC questions capacity; very limited life expectancy (e.g. anticipated discharge to hospice)
• non-English/non-Spanish speaking.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-Based Physical Therapy	Home-based physical therapy	-
Control-30-minute counseling session	Usual Care	Participants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge.

Primary Outcome Measures

Name	Time	Method
Activities of Daily Living (ADL) Decline	5 Weeks	Assessment of the functional dependence or independence in carrying out activities of daily living, including bathing, dressing, toileting, transferring, continence, and feeding.

Secondary Outcome Measures

Name	Time	Method
Mortality Rate	5 Weeks
Hospital readmission rate	5 Weeks
Decline in self-perceived physical health (measured by SF-12 PCS)	5 Weeks	Health status measure that addresses both physical and mental health.
Mean time spent in sedentary activity	5 Weeks

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States