Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients

Old Age; Debility Clinical Trial

Official title:

Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026802
• Other study ID #: 18-01905
• Status: Completed
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to decrease deconditioning of elderly inpatients in acute care institutions and to assess the safety and feasibility of a newly developed resistance training device. Investigators believe this device will help hospitalized seniors maintain their independence by preventing the loss of functionality from deconditioning and improve value of care through decreased length of stay and utilization of care. Current therapy will be complemented with a new in--bed resistance training device to target weak elderly patients and standardize progressive resistance training in facilities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients greater than or equal to 70 years old
• Admitted to acute inpatient medicine unit at NYU Langone Health (17E and 17W) from - -
• - - Emergency Department
• Receiving Physical Therapy
• Initial AMPAC 6 clicks score 11-18
• English Speaking

Exclusion Criteria:

• ICU level care
• Acute cardiac risk (including recent acute MI and stroke, unstable arrhythmias, or uncontrolled hypertension)
• Exercise-limiting physical disability (ie rotator cuff injury, neurologic impairment)
• Severe cognitive impairment (1) No significant dementia or delirium (2) Patient able to accept readiness for PT and comprehend education
• Contact Precautions

Related Conditions & MeSH terms

• Old Age; Debility

Intervention

Other:
• In-Bed Resistance Training Device
Physical Therapy using the in bed training device
• Standard of Care
Does not include early implementation of physical therapy

Locations

Country	Name	City	State
United States	NYU Langone Health	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	AMPAC 6 Clicks Composite PT (range 11-18)	The AM - PAC measures 3 functional domains: basic mobility, daily activities and applied cognition . It may be used for assessment in adults with a wide range of diagnoses and levels of performance in the 3 domains . The '6 - Clicks' instruments may have advantages over the instruments previously developed for the acute care setting in that they are simple and quick to complete, provide a transparent measure of patients' capabilities in functional areas important for prioritization of therapy resources , and use Item Response Theory to derive a common metric that can be linked with other short forms derived from the AM - PAC instrument.	1 Year
Secondary	Grip Strength using a dynamometer	Quantified by measuring the amount of static force that the hand can squeeze around a dynamometer	30 seconds
Secondary	Modified 30 second sit to stand	Count of the number of times a patient is able to come to a modified standing position in 30 seconds	1 Year
Secondary	SF-12	Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.	1 Year