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OpenTrials
Completed

NCT Number: NCT04026802

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

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.

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Key information

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-Bed Resistance Training Device

Other

Physical Therapy using the in bed training device

Standard of care

Other

Does not include early implementation of physical therapy

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2019
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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