Back to resultsImplementing Resistance Exercise to Reduce Frailty for Older Adult
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance exercise
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
Inclusion criteria for Home Care Aides:
- Employees of Help at Home, with one eligible client
Inclusion criteria for clients:
- aged 65+ years
- receive HCA services two or more days per week
- English-speaking
- not currently participating in regular exercise as defined as 30 minutes three or more days per week, - - no health problems that contraindicate participation in exercise based on the EASY: Exercise Assessment and Screening for You
- Telephone Interview for Cognitive Status score > 26
Exclusion criteria for HCAs:
- no clients who enroll in the study
Exclusion criteria for clients:
- legally blind, no voluntary extremity movement
- physician does not provide clearance for participation
- classified as non-frail based on the SHARE-FI frailty testing
- Telephone Cognitive Status score < 25.
Sites / Locations
- Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Control
Intervention
Arm Description
Usual Care Group
Intervention Group
Outcomes
Primary Outcome Measures
Number of participants with frailty or pre-frailty as assessed by the SHARE-FI
Secondary Outcome Measures
Scores of self-reported overall health as measured by the PROMIS-global health
Quadriceps muscle strength as assessed by the 30 second chair rise test
Full Information
NCT ID
NCT02942992
First Posted
October 4, 2016
Last Updated
March 11, 2019
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT02942992
Brief Title
Implementing Resistance Exercise to Reduce Frailty for Older Adult
Official Title
Implementing Resistance Exercise to Reduce Frailty for Older Adult Medicaid Waiver Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
August 8, 2017 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
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
To develop an intervention specifically targeted for these clients who have the frailty syndrome. The Investigators propose to develop an exercise intervention that can reduce frailty in older adults to facilitate their ability to age-in-place. The long-term objective of this work is to develop a package of interventions that can be administered within the existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal of this proposal is to develop a resistance exercise intervention to reduce frailty in older adults receiving long term care services in their home through the Illinois Community Care Program, a HCBS Waiver Program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care Group
Arm Title
Intervention
Arm Type
Other
Arm Description
Intervention Group
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise
Intervention Description
resistance exercise
Primary Outcome Measure Information:
Title
Number of participants with frailty or pre-frailty as assessed by the SHARE-FI
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Scores of self-reported overall health as measured by the PROMIS-global health
Time Frame
26 weeks
Title
Quadriceps muscle strength as assessed by the 30 second chair rise test
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for Home Care Aides:
- Employees of Help at Home, with one eligible client
Inclusion criteria for clients:
aged 65+ years
receive HCA services two or more days per week
English-speaking
not currently participating in regular exercise as defined as 30 minutes three or more days per week, - - no health problems that contraindicate participation in exercise based on the EASY: Exercise Assessment and Screening for You
Telephone Interview for Cognitive Status score > 26
Exclusion criteria for HCAs:
- no clients who enroll in the study
Exclusion criteria for clients:
legally blind, no voluntary extremity movement
physician does not provide clearance for participation
classified as non-frail based on the SHARE-FI frailty testing
Telephone Cognitive Status score < 25.
Facility Information:
Facility Name
Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29696165
Citation
Danilovich MK, Diaz L, Ciolinio JD, Corcos DM. Functional resistance activities to impact frailty: A protocol for a randomized controlled trial involving home care aide and frail older adult dyads. Contemp Clin Trials Commun. 2017 May 12;7:28-32. doi: 10.1016/j.conctc.2017.05.006. eCollection 2017 Sep.
Results Reference
derived
Learn more about this trial
Implementing Resistance Exercise to Reduce Frailty for Older Adult
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