Old Age; Debility Clinical Trial
Official title:
Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
Verified date | April 2021 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | January 1, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Grip Strength using a dynamometer | Quantified by measuring the amount of static force that the hand can squeeze around a dynamometer | 30 seconds | |
Secondary | 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 | |
Secondary | 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 |
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