Implementing Resistance Exercise to Reduce Frailty for Older Adult

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02942992
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Actual Duration (Months): 16
• Patients Per Site Per Month: 7.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia	Behavioral: Resistance exercise	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Implementing Resistance Exercise to Reduce Frailty for Older Adult Medicaid Waiver Recipients
• Actual Study Start Date: Mar 30, 2017
• Actual Primary Completion Date: Aug 8, 2017
• Actual Study Completion Date: Jul 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Usual Care Group
Other: Intervention Intervention Group	Behavioral: Resistance exercise; resistance exercise

Outcome Measures

Primary Outcome Measures

1. Number of participants with frailty or pre-frailty as assessed by the SHARE-FI [26 weeks]

Secondary Outcome Measures

1. Scores of self-reported overall health as measured by the PROMIS-global health [26 weeks]

2. Quadriceps muscle strength as assessed by the 30 second chair rise test [26 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Margaret Danilovich, Instructor, Northwestern University
• ClinicalTrials.gov Identifier: NCT02942992
• Other Study ID Numbers: STU00201777
• First Posted: Oct 24, 2016
• Last Update Posted: Mar 13, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcopenia; Frailty

Study Results

No Results Posted as of Mar 13, 2019