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

NCT04026802 | Completed

• 1 other identifier: 18-01905
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Old Age; Debility

Keywords

deconditioning of elderly inpatients; loss of functionality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Grip Strength using a dynamometer

  30 seconds

• Modified 30 second sit to stand

  1 Year

• SF-12

  1 Year

Study Arms (2)

In--Bed Resistance Training Device

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

No resistance training device

Other: Standard of Care

Interventions

In-Bed Resistance Training Device OTHER

Physical Therapy using the in bed training device

In--Bed Resistance Training Device

Standard of Care OTHER

Does not include early implementation of physical therapy

Standard of Care

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alex Moroz

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 19, 2019
• Study Start: August 27, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

US (1)