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出境医 / 临床实验 / 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

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.

Condition or disease Intervention/treatment Phase
Old Age; Debility Other: In-Bed Resistance Training Device Other: Standard of Care Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
Actual Study Start Date : August 27, 2019
Actual Primary Completion Date : January 1, 2021
Actual Study Completion Date : January 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: In--Bed Resistance Training Device
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
Physical Therapy using the in bed training device
Active Comparator: Standard of Care
No resistance training device
 Other: Standard of Care
Does not include early implementation of physical therapy
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   70 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Alex Moroz New York Langone Medical Center
Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE August 27, 2019
Actual Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
Official Title  ICMJE Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Old Age; Debility
Intervention  ICMJE
  • Other: In-Bed Resistance Training Device
    Physical Therapy using the in bed training device
  • Other: Standard of Care
    Does not include early implementation of physical therapy
Study Arms  ICMJE
  • Experimental: In--Bed Resistance Training Device
    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.
    Intervention: Other: In-Bed Resistance Training Device
  • Active Comparator: Standard of Care
    No resistance training device
    Intervention: Other: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2021) 		11
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2019) 		155
Actual Study Completion Date  ICMJE January 1, 2021
Actual Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 100 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026802
Other Study ID Numbers  ICMJE 18-01905
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alex Moroz New York Langone Medical Center
PRS Account NYU Langone Health
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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