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Progressive Multi-Component (PMC) for Aging Adults
N/A
Waitlist Available
Led By Jennifer E Stevens-Lapsley, MPT, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up quantification of falls, ed visits, nursing home days, and hospitalizations at 30, 60, 90, and 180 days post randomization
Awards & highlights
Summary
This research study explores the effects of a progressive, multi-component intervention following a stay in the hospital or rehabilitation facility. The purpose of this research study is to compare a multi-component intervention (higher intensity exercise, nutritional supplementation, and greater emphasis on functionally enhanced care transitions) with usual care physical therapy.
Eligible Conditions
- Aging Adults
- Physical Deconditioning
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ quantification of falls, ed visits, nursing home days, and hospitalizations at 30, 60, 90, and 180 days post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~quantification of falls, ed visits, nursing home days, and hospitalizations at 30, 60, 90, and 180 days post randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Short Physical Performance Battery (SPPB)
Secondary study objectives
ActivPAL
Falls Efficacy Scale-International
Fast walking speed (4MW)
+4 moreOther study objectives
Falls, Emergency Department visits, nursing home days, hospitalizations
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Progressive Multi-Component (PMC)Experimental Treatment1 Intervention
High intensity strength training protocol, daily protein supplementation, functionally enhanced transitions of care
Group II: Enhanced Usual Care (EUC)Active Control1 Intervention
Low intensity rehabilitation protocol, standard education for nutrition, standard transitions of care
Name of Participant Arm updated to "Enhanced Usual Care" from "Usual Care" effective 8/16/18 to distinguish from Passive Comparator "True Usual Care" group.
Group III: True Usual Care (TUC)Active Control1 Intervention
Real-world home health rehabilitation, real-world education for nutrition, real-world transitions of care, non-randomized observation
Participants in the "True Usual Care" group will receive physical therapy following discharge from acute hospitalization. Activities and number of visits are not protocolized and are provided by real world home health care providers per physician orders.
Participant Arm added effective 8/16/18.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Progressive Multi-Component (PMC)
2016
N/A
~360
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,255 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
598 Previous Clinical Trials
10,377,806 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,481 Total Patients Enrolled
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