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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04026802
Enrollment
11
Registered
2019-07-19
Start date
2019-08-27
Completion date
2021-01-01
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Old Age; Debility

Keywords

deconditioning of elderly inpatients, loss of functionality

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.

Interventions

OTHERIn-Bed Resistance Training Device

Physical Therapy using the in bed training device

OTHERStandard of Care

Does not include early implementation of physical therapy

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AMPAC 6 Clicks Composite PT (range 11-18)1 YearThe 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

MeasureTime frameDescription
Grip Strength using a dynamometer30 secondsQuantified by measuring the amount of static force that the hand can squeeze around a dynamometer
Modified 30 second sit to stand1 YearCount of the number of times a patient is able to come to a modified standing position in 30 seconds
SF-121 YearTwo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026