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

Overview

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.

Full Title of Study: “Safety and Feasibility of a Novel In–Bed Resistance Training Device in Elderly Inpatients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: In–Bed Resistance Training Device
    • 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.
  • Active Comparator: Standard of Care
    • No resistance training device

Clinical Trial Outcome Measures

Primary Measures

  • AMPAC 6 Clicks Composite PT (range 11-18)
    • Time Frame: 1 Year
    • 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.

Secondary Measures

  • Grip Strength using a dynamometer
    • Time Frame: 30 seconds
    • Quantified by measuring the amount of static force that the hand can squeeze around a dynamometer
  • Modified 30 second sit to stand
    • Time Frame: 1 Year
    • Count of the number of times a patient is able to come to a modified standing position in 30 seconds
  • SF-12
    • Time Frame: 1 Year
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NYU Langone Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alex Moroz, Principal Investigator, New York Langone Medical Center

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