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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Old Age; Debility

Intervention / Treatment
-----------------
* Other: In-Bed Resistance Training Device
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In--Bed Resistance Training Device<br>The present invention provides full body resistance training devices that attach to a planar edge, such as a footboard, headboard, or sideboard of a bed. The devices employ resistance bands for resistance training in both the incursion (force applying) and excursion (force releasing) phase of exercise. | Other: In-Bed Resistance Training Device<br>* Physical Therapy using the in bed training device<br>|
| Active Comparator: Standard of Care<br>No resistance training device | Other: Standard of Care<br>* Does not include early implementation of physical therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip Strength using a dynamometer | Quantified by measuring the amount of static force that the hand can squeeze around a dynamometer | 30 seconds | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deconditioning of elderly inpatients, loss of functionality