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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03595605
Other study ID # 17-01792
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 16, 2018
Est. completion date March 30, 2019

Study information

Verified date May 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will incorporate the use of wearable actigraphy devices (Fitbit) on research participants admitted to medicine inpatient units at Tisch Hospital and/or NYU Brooklyn. The investigator's sample size will be 600 randomized into two groups, with basic inclusion criteria including age greater than 65 years and pre-hospital ambulatory status. While both groups will be monitored in terms of their activity (specifically pedometer data), the intervention group will have twice daily encouragement of ambulation. Once a subject is enrolled, data will be collected daily and at time of discharge.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date March 30, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers No
Gender All
Age group 66 Years to 100 Years
Eligibility Inclusion Criteria:

- Admitted to acute inpatient medicine unit

- Ambulatory without assistive device prior to hospitalization

- Medical clearance to ambulate on the unit

- Active MyChart account or willing to activate MyChart account

- iOS or Android device

Exclusion Criteria:

- Patients less than or equal to 65 years old

- Not Admitted to acute inpatient medicine unit

- Ambulatory with assistive device prior to hospitalization

- No Medical clearance to ambulate on the unit

- Inactive MyChart account and not willing to activate MyChart account

- No iOS or Android device

In addition, an individual who meets any of the following criteria will be excluded from participation in this study:

- Oxygen requirement at rest

- Lower extremity prosthesis

- Admitted for joint replacement surgery

- History of frequent falls

- Admitted for syncope.

- If patients have specifically opted out of being contacted about research (visible in the Epic header while in their chart)

- Admitted from nursing home

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Ambulation
This group will be encouraged twice daily to ambulate
Other:
Standard of Care
Care as usual at inpatient NYU Langone

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine how many steps patients admitted to the medicine units are taking at baseline Steps will be measured using a wearable device (FitBit) designed to track number of steps for the duration of their hospital stay 1 Day
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