Back to resultsSafety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
Primary Purpose
Old Age; Debility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Bed Resistance Training Device
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Old Age; Debility focused on measuring deconditioning of elderly inpatients, loss of functionality
Eligibility Criteria
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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
In--Bed Resistance Training Device
Standard of Care
Arm Description
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.
No resistance training device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Grip Strength using a dynamometer
Quantified by measuring the amount of static force that the hand can squeeze around a dynamometer
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04026802
Brief Title
Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
Official Title
Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age; Debility
Keywords
deconditioning of elderly inpatients, loss of functionality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In--Bed Resistance Training Device
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
No resistance training device
Intervention Type
Other
Intervention Name(s)
In-Bed Resistance Training Device
Intervention Description
Physical Therapy using the in bed training device
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Does not include early implementation of physical therapy
Primary Outcome Measure Information:
Title
AMPAC 6 Clicks Composite PT (range 11-18)
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Grip Strength using a dynamometer
Description
Quantified by measuring the amount of static force that the hand can squeeze around a dynamometer
Time Frame
30 seconds
Title
Modified 30 second sit to stand
Description
Count of the number of times a patient is able to come to a modified standing position in 30 seconds
Time Frame
1 Year
Title
SF-12
Description
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.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Moroz
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
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