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Clinical Trials/NCT02804906
NCT02804906
Completed
N/A

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

NYU Langone Health1 site in 1 country27 target enrollmentJune 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Myocardial Infarction (AMI)
Sponsor
NYU Langone Health
Enrollment
27
Locations
1
Primary Endpoint
Activities of Daily Living (ADL) Decline
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
January 14, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of acute myocardial infarction (AMI).

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.

Outcomes

Primary Outcomes

Activities of Daily Living (ADL) Decline

Time Frame: 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 Outcomes

  • Mortality Rate(5 Weeks)
  • Decline in self-perceived physical health (measured by SF-12 PCS)(5 Weeks)
  • Mean time spent in sedentary activity(5 Weeks)
  • Hospital readmission rate(5 Weeks)

Study Sites (1)

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